Effect of Multi-Strain Probiotics as an Anti-Obesity Among Overweight and Obese Saudi Adults
Phase: PHASE3
Conditions: Obesity, Adult
Sponsor: King Saud University

Protocol E-20-5503                                                                                                           Confidential 
 
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Cover letter 
 
 
 
 
 
Protocol Title: 
Effect of Multi-Strain Probiotics as an Anti-Obesity 
among Overweight and Obese Saudi Adults 
 
 
Issued on  
6/8/2021 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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PROTOCOL TEMPLATE 
 
Instructions to User: 
1. Sections and text that are in regular font and that have not been 
highlighted in grey represent standard language.  In general, these sections 
should be present in your final protocol and the language should not be 
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and language may be necessary to meet the needs of your protocol.  Please 
review the language carefully to make sure that it is accurate for your study. 
2. Sections that are highlighted in grey, but that have regular font, represent 
sections or information that needs to be customized as applicable to your study, 
but the language that is present is generally considered to be standard if that 
section (or procedure) applies to your protocol. 
3. Sections that are highlighted in grey, and where the text is italicized, 
represent instructions with some example text.  All require complete 
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5. When your protocol is complete, review it to ensure that all highlighting and 
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SAMIRA MOHAMMED ALMALKI 
Clinical Research Protocol 
Academic study (Doctor of Philosophy degree) 
Protocol Number: 
E-20-5503  
Version Date: 
5/8/2021 
Investigational Product: 
Hexbio Probiotic supplementation  
Development Phase: 
3 phace 
Sponsor: 
Samira Almalki 
College of Food Science and Agriculture, King Saud 
University  
Riyadh 
Funding Organization: 
Non-fund 
Principal Investigator: 
Name: Prof. Hanan Abdullah Al Fawaz  
 
Telephone: 0118055890  
 
 
E-mail: halfawaz@ ksu.edu.sa   
Medical Monitor: 
Name: Dr. Mariam Eid Al- Juhani  
 
Telephone: 058 144 4264 
 
 
 
E-mail: maljohani@ksu.edu.sa   
Coordinating Center: 
If applicable 
 
Approval: 
Health Science College on Human Subjects (H-01-R-002)   
 
PI. Prof. Hanan Abdullah Al Fawaz 
 
6/8/2021 
This confidential information about an investigational product is provided for the exclusive use of 
investigators of this product and is subject to recall at any time.  The information in this document 
may not be disclosed unless federal or state law or regulations require such disclosure.  Subject to the 
foregoing, this information may be disclosed only to those persons involved in the study who have a 
need to know, with the obligation not to further disseminate this information.   

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PROTOCOL AGREEMENT 
 
I have read the protocol specified below. In my formal capacity as Investigator, my duties 
include ensuring the safety of the study subjects enrolled under my supervision and 
providing Samira Almalki with complete and timely information, as outlined in the 
protocol.  It is understood that all information pertaining to the study will be held strictly 
confidential and that this confidentiality requirement applies to all study staff at this site. 
Furthermore, on behalf of the study staff and myself, I agree to maintain the procedures 
required to carry out the study in accordance with accepted GCP principles and to abide 
by the terms of this protocol. 
 
Protocol Number:  E-20-5503 
 
Protocol Title: Effect of Multi-Strain Probiotics as an Anti-Obesity among Overweight and Obese Saudi 
Adults  
 
 
 
5/8/2021 
Investigator Signature  
 
Date 
PhD student: Samira Mohammed Almalki 
Print Name and Title 
Site # 
1 
 
Site Name 
Occupational clinic, King Khaled Hospital University
Address 
King Saud University 
Phone Number 
0542839259 

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TABLE OF CONTENTS 
 
1 
BACKGROUND .................................................................................................................. 4 
1.1 
Overview of Non-Clinical Studies ............................................................................... 11 
1.2 
Overview of Clinical Studies ....................................................................................... 11 
2 
STUDY RATIONALE ........................................................................................................ 11 
2.1 
Risk / Benefit Assessment ........................................................................................... 12 
3 
STUDY OBJECTIVES ....................................................................................................... 12 
3.1 
Primary Objective ........................................................................................................ 12 
3.2 
Secondary Objectives .................................................................................................. 12 
4 
STUDY DESIGN ................................................................................................................. 12 
4.1 
Study Overview ........................................................................................................... 12 
5 
CRITERIA FOR EVALUATION ...................................................................................... 13 
5.1 
Primary Efficacy Endpoint .......................................................................................... 13 
5.2 
Secondary Efficacy Endpoints ..................................................................................... 13 
5.3 
Safety Evaluations ....................................................................................................... 13 
5.4 
Other Evaluations (include only if applicable) ............................................................ 13 
6 
SUBJECT SELECTION ..................................................................................................... 13 
6.1 
Study Population .......................................................................................................... 13 
6.2 
Inclusion Criteria ......................................................................................................... 13 
6.3 
Exclusion Criteria ........................................................................................................ 14 
7 
CONCURRENT MEDICATIONS .................................................................................... 14 
7.1 
Allowed ........................................................................................................................ 14 
7.2 
Prohibited
 
Error! Bookmark not defined. 
8 
STUDY TREATMENTS ..................................................................................................... 14 
8.1 
Method of Assigning Subjects to Treatment Groups ................................................... 14 
8.2 
Blinding ....................................................................................................................... 15 
8.3 
Test and Control Formulation ...................................................................................... 15 
8.4 
Supply of Study Medication at the Site ....................................................................... 17 
8.5 
Study Medication Accountability ................................................................................ 18 
8.6 
Measures of Treatment Compliance ............................................................................ 18 
9 
STUDY PROCEDURES AND GUIDELINES ................................................................. 18 
9.1 
Clinical Assessments ................................................................................................... 18 
9.2 
Clinical Laboratory Measurements (include sections as appropriate) ......................... 19 
9.3 
Pharmacokinetic Measurements .................................................................................. 20 
9.4 
Research Laboratory Measurements (include sections as appropriate) ....................... 20 
10 EVALUATIONS BY VISIT ............................................................................................... 20 
10.1 Visit 1 (Day/Week/Month #) ....................................................................................... 20 

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10.2 Visit 2 (Day/Week/Month # include visit window) ..................................................... 21 
10.3 Visit 3 (Day/Week/Month # include visit window)
 
Error! Bookmark not defined. 
10.4 Visit 4 (Day/Week/Month # include visit window)
 
Error! Bookmark not defined. 
10.5 Visit 5 (Follow-up or Day/Week/Month # include visit window)
 
Error! Bookmark not defined. 
10.6 Early Withdrawal Visit ................................................................................................ 21 
11 ADVERSE EXPERIENCE REPORTING AND DOCUMENTATION ........................ 21 
11.1 Adverse Events ............................................................................................................ 21 
11.2 Serious Adverse Experiences (SAE) ........................................................................... 21 
11.3 Protocol Defined Important Medical Findings Requiring Real Time Reporting ........ 22 
11.4 Medical Monitoring ..................................................................................................... 22 
11.5 Safety Management Plan ............................................................................................. 4 
12 DISCONTINUATION AND REPLACEMENT OF SUBJECTS ................................... 22 
12.1 Withdrawal of Subjects ................................................................................................ 22 
12.3 Replacement of Subjects .............................................................................................. 23 
13 PROTOCOL VIOLATIONS .............................................................................................. 23 
14 DATA SAFETY MONITORING (OPTIONAL SECTION – INCLUDE WHEN 
APPROPRIATE) ........................................................................................................................ 24 
15 STATISTICAL METHODS AND CONSIDERATIONS ................................................ 24 
15.1 Data Sets Analyzed ...................................................................................................... 24 
15.2 Demographic and Baseline Characteristics ................................................................. 24 
15.3 Analysis of Primary Endpoint ...................................................................................... 24 
15.4 Analysis of Secondary Endpoints ................................................................................ 24 
15.5 Interim Analysis ........................................................................................................... 24 
15.6 Sample Size and Randomization ................................................................................. 24 
16 DATA COLLECTION, RETENTION AND MONITORING ........................................ 25 
16.1 Data Collection Instruments ........................................................................................ 25 
16.2 Data Management Procedures ..................................................................................... 25 
16.3 Data Quality Control and Reporting ............................................................................ 25 
16.4 Archival of Data ........................................................................................................... 25 
16.5 Availability and Retention of Investigational Records ................................................ 25 
16.6 Monitoring ................................................................................................................... 26 
16.7 Subject Confidentiality ................................................................................................ 26 
17 ADMINISTRATIVE, ETHICAL, REGULATORY CONSIDERATIONS ................... 26 
17.1 Protocol Amendments .................................................................................................. 26 
17.2 Institutional Review Boards and Independent Ethics Committees .............................. 26 
17.3 Informed Consent Form ............................................................................................... 27 

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17.4 Publications .................................................................................................................. 27 
17.5 Investigator Responsibilities ........................................................................................ 27 
 

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LIST OF ABBREVIATIONS 
Add all other abbreviations referenced in the protocol and delete any not referenced in 
the protocol. 
AE 
adverse event 
ALT 
alanine aminotransferase 
AST 
aspartate aminotransferase 
BUN 
blood urea nitrogen 
CFR 
Code of Federal Regulations 
CRF 
case report form 
CRP 
C-reactive protein 
DMC 
Data Monitoring Committee 
DSMB 
Data Safety Monitoring Board 
ESR 
erythrocyte sedimentation rate 
FDA 
Food and Drug Administration 
FEF25%-75% 
forced expiratory flow 
FEV1 
forced expiratory volume over one second 
FVC 
forced vital capacity 
GCP 
Good Clinical Practice 
GGT 
gamma-glutamyl transferase 
HIPAA 
Health Insurance Portability and Accountability Act of 1996 
ICF 
informed consent form 
ICH 
International Conference on Harmonisation 
IEC 
Independent Ethics Committee 
IL-8 
Interleukin-8 
IRB 
Institutional Review Board 
IV 
intravenous 
LDH 
lactate dehydrogenase 
mEq 
milliequivalent 
PI 
Principal Investigator 
PK 
pharmacokinetic 
SAE 
serious adverse experience 
SGOT 
serum glutamic oxaloacetic transaminase 
SGPT 
serum glutamate pyruvate transaminase 

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PROTOCOL SYNOPSIS 
TITLE 
Effect of Multi-Strain Probiotics as an Anti-Obesity among Overweight and Obese 
Saudi Adults  
SPONSOR 
Self-Funded (Investigator Investment)  
FUNDING 
ORGANIZATION 
Non-funded 
NUMBER OF SITES 
One 
RATIONALE 
Regulating microbiota is considered a potential therapeutic 
avenue for obesity through many different mechanisms. 
Exacerbate obesity and associated risk factors are noticed in our 
society among many social segments for different ages. On the 
treatment side, most obesity surgery treatments are expensive, prone to 
failure, and have many side effects, which is a health and economic 
burden on our government. 
Since limited studies have been conducted internationally on 
human subjects, more investigation is needed in this field. Locally, 
much fewer works on humans are done. Therefore, this study sheds 
light on the investigation of the anti-obesity effect of probiotic 
supplementation.  
 
STUDY DESIGN 
This is a randomized, double-blind, placebo-controlled phase 3 study. 
PRIMARY 
OBJECTIVE 
Study the anti-obesity effect of consuming multi-Strain 
probiotic supplementation on weight loss for overweight and obese 
adults. 
 
SECONDARY 
OBJECTIVES 
1. Investigate the effect of probiotics on reducing 
Lipopolysaccharides LPS. 
2. Determine the effect of probiotics on liver functions. 
3. Study the association between probiotics and food intake. 
4. Evaluate the role of gender difference in response to probiotic.  
 
NUMBER OF 
SUBJECTS 
90 
SUBJECT 
SELECTION 
CRITERIA 
Inclusion Criteria: 
1. Adult’s male and female ages between 19 to 40 years. 
2. BMI (in kg/m
2
) from 25 to 35, (WHO, n. d.) WC > 88 cm
 
(women) or > 102 cm (men) (lean et al, 1995). 
3. Stable body weight in the previous month of the trial. 
 
 
Exclusion Criteria: 

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• 
Participants who suffer from diseases and on treatment, such as 
immune system diseases or thyroid disorders.  
• 
Pregnant women or who plans to be pregnant. 
• 
Participants who had gastrointestinal surgery. 
• 
Hormone replacement therapy. 
• 
Participants who taking antibiotic. 
• 
Participants who consume probiotic or prebiotic supplementation 
regularly.  
 
 
TEST PRODUCT, 
DOSE, AND ROUTE 
OF 
ADMINISTRATION 
Product: (HEXBIO®) containing MCP® BCMC® strains 
Each sachet containing 3g / 90 billion CFU 
Oral consumption. 
 Two sachets per day, by dissolving the sachet content in a glass of 
room-temperature water, one before breakfast and one before going to 
bed, for three months length. 
 
CONTROL 
PRODUCT, DOSE 
AND ROUTE OF 
ADMINISTRATION 
The placebo sachets containing only the excipients, i.e., maize starch 
and maltodextrins. The placebo was indistinguishable in color, smell, 
and taste from the probiotic formulation. All participants will be asked 
to consume two sachets per day, one before breakfast and one before 
going to bed, after dissolving the content in a glass of room-
temperature water. 
DURATION OF 
SUBJECT 
PARTICIPATION 
AND DURATION OF 
STUDY 
Subjects will be on study for up to 3 months 
Screening:  In the beginning of study 
Treatment:  3 months  
Follow-up:  3 months 
The total duration of the study is expected to be 6 months for subject 
recruitment and 6 for final subject follow-up. 
PRIMARY ENDPOINT 
• 
The primary outcome is the relative change in WC measurement 
from baseline to end-of-treatment. 
SECONDARY 
ENDPOINTS 
• 
Other obesity-related outcomes included body weight, WC, and 
hip circumference (HC). 
STATISTICS 
Primary Analysis Plan 
The primary outcome of this study is the difference in waist 
circumference between groups after 12 weeks of supplementation. 
The analysis of this study will include all the patients using intention 
to treat (ITT) methodology. Waist circumference of two groups after 
12 weeks of supplementation will be examined for statistical 
significant using repeated measures ANOVA. 

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Rationale for Number 
of Subjects 
The study population depends on the study result of Gomes and his 
colleagues who used the G-Power software (version 3.0.10) to 
calculate the sample size. The primary outcome in that study is the 
difference in waist circumference between groups. The power 
calculation requires 17 participants in each group (95% power; 5% 
type I error) to detect a difference in waist circumference (Gomes et 
al, 2018). In this study, to avoid any later drop-off, both groups will 
be set to have 45 participants. 
 

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1 
BACKGROUND 
There are many studies indicated that some strains  are involved successfully in weight 
reduction especially Bifidobacterium and Lactobacillus species. HEXBIO® is a 
formulation containing six microorganism strains (Lactobacillus acidophilus 
BCMC®12130, Lactobacillus casei subsp BCMC®12313, Lactobacillus lactis 
BCMC®12451, Bifidobacterium bifidum BCMC®02290, Bifidobacterium infantis 
BCMC®02129, and Bifidobacterium longum BCMC®02120). All the six microorganism 
strains in HEXBIO® have been proven to be gastric acid resistant and bile salt resistant, 
thus able to survive via intestinal tract transit. The product has been tested in 18 clinical 
trials and thus far there has been no adverse effects for human consumption reported.  
 
1.1 
Overview of Non-Clinical Studies 
The acute toxicity of HEXBIO® have been tested via acute oral toxicity study and test 
reports concluded that the product can be considered as Category 5 (unclassified); 
whereby the LD50 cut- off value is equal or more than 5000mg/kg (> 5000mg/kg) body 
weight. The 6 microorganism strains in HEXBIO® have been assessed via in-vitro studies 
for their tolerance to bile salt, tolerance to gastric acid and their ability to exhibit the Bile 
Salt Hydrolase (BSH) enzyme. All 6 microorganism strains has been proven to be both 
bile salt tolerant, gastric acid tolerant, and able to exhibit the BSH enzyme.  
1.2 
Overview of Clinical Studies 
There are many published Clinical Trials with HEXBIO®. For example, Mahadzir, et. al., 
(2017) conducted a double-blind randomized controlled trial to study the effect of 
HEXBIO® on body weight. The result was insignificant; however, the length of study 
was only 4 weeks. The Investigator’s Brochure is attached in the CD. 
2 
STUDY RATIONALE 
There are growing interests in the effectiveness of probiotics for treating chronic 
diseases. Regulating microbiota is considered a potential therapeutic avenue for obesity 
through many different mechanisms. 
Exacerbate obesity and associated risk factors are noticed in our society among 
many social segments for different ages. On the treatment side, most obesity surgery 
treatments are expensive, prone to failure, and have many side effects, which is a health and 
economic burden on our government. 
Since limited studies have been conducted internationally on human subjects, more 
investigation is needed in this field. Locally, much fewer works on humans are done. 
Therefore, this study sheds light on the investigation of the anti-obesity effect of probiotic 
supplementation.  

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2.1 
Risk / Benefit Assessment 
Understanding the composition of gut microbiota helps to find appropriate solutions to 
control the increasing weight. In animal studies, physical and biochemical parameters, 
metabolic and inflammatory markers, and alterations in GM diversity revealed beneficial 
results against obesity whereas the results in humans are still rare.  Alteration of the GM 
via applying natural or supplementation probiotic is considered as a new and promising 
therapeutic intervention treating human obesity. 
3 
STUDY OBJECTIVES 
3.1 
Primary Objective 
The primary objective is to Study the anti-obesity effect of consuming multi-Strain 
probiotic supplementation on overweight and obese adults. 
3.2 
Secondary Objectives 
1. Evaluate the anti-obesity effect of multi-Strain probiotic supplementation  
2. Investigate the effect of probiotics on reducing Lipopolysaccharides LPS. 
3. Determine the effect of probiotics on liver functions. 
4. Study the association between probiotics and food intake. 
5. Evaluate the role of gender difference in response to probiotic.  
4 
STUDY DESIGN 
4.1 
Study Overview 
This is a single center, double-blind, placebo-controlled, randomized, trial.  Subjects 
number will be 90 participants.  Each subject will be administered a one dose of probiotic 
supplementation, two times per day, for three months, consisting each time of stable doses 
of active or placebo.   
  Subjects will be assigned to the treatment in random order.  Evaluations will be taken at 
baseline and at the end of study. 
Screening data will be reviewed to determine subject eligibility.  Subjects who meet all 
inclusion criteria and none of the exclusion criteria will be entered into the study. 
The following treatment regimens will be used: 
• Experimental treatment is Hexbio sachet containing 3g / 90 billion CFU 
• Placebo sachets containing only the excipients, i.e., maize starch and maltodextrins. The 
placebo was indistinguishable in color, smell, and taste from the probiotic formulation.  
Total duration of subject participation will be three months.  Total duration of the study is 
expected to be six months. 

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5 
CRITERIA FOR EVALUATION 
5.1 
Primary Efficacy Endpoint 
The primary outcome is the relative change in WC measurement from baseline to end-of-
treatment. 
5.2 
Secondary Efficacy Endpoints 
Other obesity-related outcomes included body weight, WC, and hip circumference (HC). 
5.3 
Safety Evaluations 
• Increasing in Antioxidants enzymes including superoxide dismutase (SOD), catalase, 
and glutathione peroxidase (GPx). 
• Decreasing in both Aspartate Transaminase (AST) and Alanine transaminase (ALT). 
• Decreasing in lipopolysaccharide LPS, which is known also as endotoxin. 
• Decreasing in blood analysis including glycated hemoglobin (HA1c) and lipid profile 
(TC, HDL-C, and TG) 
5.4 
Other Evaluations (include only if applicable) 
Primary Efficacy Endpoint: The primary outcome is the relative change in WC 
measurement from baseline to end-of-treatment. 
Secondary Efficacy Endpoints: Other obesity-related outcomes included body weight, 
WC, and hip circumference (HC). 
 
6 
SUBJECT SELECTION 
6.1 
Study Population 
Subjects with BMI (in kg/m2) from 25 to 35 who meet the inclusion and exclusion criteria 
will be eligible for participation in this study.   
6.2 
Inclusion Criteria 
1. Adult’s male and female ages between 19 to 40 years. 
2. BMI (in kg/m
2
) from 25 to 35, or  WC > 88 cm
 
(women) or > 102 cm (men). 
3. Stable body weight in the previous month of the trial. That can be detected by 
asking the participants about their weight; slight change doesn't matter. Also, case 
report study includes questions related to the weight, for example: Have you 

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enrolled in any diet during the past three weeks? That can also help to detect the 
stability of weight. 
4. Written informed consent (and assent when applicable) obtained from subject or 
subject’s legal representative and ability for subject to comply with the 
requirements of the study. 
6.3 
Exclusion Criteria 
• 
Participants who suffer from diseases and on treatment, such as immune system 
diseases or thyroid disorders.  
• 
Pregnant women or who plans to be pregnant. That can be achefed by asking 
participant wether they are pregnant or planning to become pregnant, If the answer is 
yes, the participant will be excluded. Other females, who are not planning to be 
pregnant, should use any of contraceptive methods. The studies didn’t mention to any 
interfering between probiotic and contraceptive, so woman who use contraceptive will 
not be excluded. 
• 
Participants who had gastrointestinal surgery. 
• 
Hormone replacement therapy. 
• 
Participants who taking antibiotic. 
• 
Participants who consume probiotic or prebiotic supplementation regularly.  
 
7 
CONCURRENT MEDICATIONS 
All subjects should be maintained on the same medications throughout the entire study 
period, as medically feasible, with no introduction of new chronic therapies. 
7.1 
Allowed Medications and Treatments 
All subjects should be free from any chronic diseases which require medications. 
8 
STUDY TREATMENTS 
8.1 
Method of Assigning Subjects to Treatment Groups 
In allocation process, a randomization center will be involved in randomizing the 
participants in two groups, also there will be allocation concealment, according to the 
following steps: 
• Hexbio company will provide sachets which only have alphabet Q or R. 

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• In the beginning of the study, participants will be given a unique number by the 
research phlebotomist. 
• The randomization scheme will be computer generated in which all participants 
will be allocated (1:1) in two different groups, group Q and group R. 
• After completing the intervention, a request letter will be sent to the company in 
order to unblind the study. 
• Then the company lab will send an unblinding letter to inform us which alphabet is 
probiotic or placebo. 
8.2 
Blinding 
Due to the objectives of the study, the identity of test and control treatments will not be 
known to investigators, research staff, or patients.  The following study procedures will be 
in place to ensure double-blind administration of study treatments: 
• Access to the randomization code will be strictly controlled.   
• Packaging and labeling of test and control treatments will be identical to maintain the 
blind.  
• Due to necessity of evaluate the activity of treatment product, both packages( with 
different letters) will be sent to microbiology lab to determine the activity of strains, 
the result will be blind without mention to any letter. 
• Full blinding is done after the last participant of the intervention is done. The 
investigator will send an email to the company asking for unblinding. 
 
The study blind will be broken on completion of the clinical study and after the study 
database has been locked. Investigators will be made aware of their subjects treatment 
assignments after all participant finish the treatment duration, three months. 
During the study, the blind may be broken only in emergencies when knowledge of the 
patient’s treatment group is necessary for further patient management. When possible, the 
Investigator should discuss the emergency with the Medical Monitor prior to unblinding.   
For blinding in emergency case, the investigator has 2 options: 
1. Have direct contact with the company (mobile) personnel in charge of blinding 
(preferrable) 
2. Assign a 3rd individual not included in the team to whom the company will share the 
blinding information. 
 
8.3 
Formulation of Test and Control Products 
Company’s name: B-CROBES LABORATORY SDN. BHD.  

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Product : HEXBIO® MCP® Granule (Original Flavour)  
Generic Name : MCP® BCMC® strains  
Trade Name : HEXBIO® 
8.3.1 
Formulation of Test Product 
HEXBIO® is a cream-coloured, original flavoured granular powder containing 6 
microorganism strains. The microorganisms / active ingredients in HEXBIO® are; 
Lactobacillus acidophilus BCMC®12130, Lactobacillus casei subsp BCMC®12313, 
Lactobacillus lactis BCMC®12451, Bifidobacterium bifidum BCMC®02290, 
Bifidobacterium infantis BCMC®02129, and Bifidobacterium longum BCMC®02120.  
 
Table X: Formulation and Measured pH of XXX and Placebo 
 
Hexbio 
Placebo 
Active 
Ingredient, 
mg/mL 
Lactobacillus acidophilus BCMC®12130, 107 mg 
 Lactobacillus casei subsp BCMC®12313, 107 mg 
Lactobacillus lactis BCMC®12451, 107 mg 
Bifidobacterium bifidum BCMC®02290, 107 mg 
Bifidobacterium infantis BCMC®02129, 107 mg 
Bifidobacterium longum BCMC®02120. 107 mg 
 
excipients, i.e., 
maize starch and 
maltodextrins 
3 g 
 
8.3.2 
Formulation of Control Product 
 
A placebo containing similar granule appearance as the treatment without 6 probiotic 
strains will be provided by the Sponsor in a plain box containing 6 zipper bags (10 sachets 
in each zipper bag). Each sachet is for single use and ready for administration. 
8.3.3 
Packaging and Labeling 
 
Packaging: Study drug is supplied in cartons containing 1,200 single use sachets. The 
sachets will be packaged in sets of 10 enclosed within a transparent zipper bag. Six zipper 
bags will be contained in one plain box labeled with instruction for use and storage. 
Twenty plain boxes will be contained in each carton. 

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Labeling: Each plain box of study drug (not carton) will be labeled with the required 
FDA warning statement, the protocol number, a treatment number, the name of the 
sponsors, and directions for patient use and storage. Each sachet will be labeled with OA-
R-01 or OA-Q-01 and Expiry date. 
 
8.4 
Supply of Study Drug at the Site 
The Sponsor will ship the supplementation after all required regulatory documentation has 
been received by the Sponsor and a contract has been executed. 
8.4.1 
Dosage/Dosage Regimen 
 
8.4.2 
Dispensing 
Investigator will dispense the product at study site. 
8.4.3 
Administration Instructions  
One sachet to be taken orally twice daily. Before or after meal, pour one sachet directly 
into the mouth. Drink a glass of water. 
 
8.5 
Supply of Study Drug at the Site 
Once the sponsor received the written request from the investigator, the sponsor will 
arrange the production of study drug which takes 1-2 months. The investigator will need 
to send a written notice and request for additional study drug if it is necessary in advance 
so the sponsor will arrange for production accordingly. 
 
B-CROBES LABORATORY SDN. BHD. (588778-K) 
18 & 20, Lintasan Perajurit 17G, Taman Teknologi Industri & Perusahaan Ipoh, 31400 
Ipoh, Perak, Malaysia. 
Contact Number: +603-5636 1708 
OA-R-01 
Study no. 
  
Treatment no. 
  
Dosage form 
3g of granules per sachet 
Instructions for Use 
1 sachet to be taken twice daily. Can be taken before or after meal. Drink a glass of 
water. 
Route of Administration 
Oral 
Storage Conditions 
Storage below 25oC. Protect from sunlight and moisture. 
Pack size 
60 sachets per box 
Expiry Date 
  
NOT FOR SALE. KEEP OUT OF REACH OF CHILDREN 
 
 
 

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8.5.1 
Storage 
Study drug should be stored by the study site at room temperature below 25ºC with air 
conditioning. If the temperature of study drug storage in the clinic/pharmacy exceeds 
25ºC, this should be reported to the Sponsor or designee and captured as a deviation. 
Subjects will be instructed to store the medication in original packaging (plain box and 
protected from sunlight) at room temperature below 25ºC according to the instructions 
outlined on the Drug Administration Instructions. 
 
8.6 
Study Drug Accountability 
An accurate and current accounting of the dispensing and return of study supplement for 
each subject if there is any side effect. All those details will be recorded by a member of 
the study site staff. The study monitor will verify these documents specially in the first 
week of the intervention. 
8.7 
Measures of Treatment Compliance 
Subjects will be asked to keep a participant’s diary noting the day and date they take their 
study probiotic supplement and any adverse events. They will be asked to bring their diary 
to next study visit along with all used and unused probiotic or placebo sachets. 
9 
STUDY PROCEDURES AND GUIDELINES 
A Schedule of Events representing the required testing procedures to be performed for the 
duration of the study is diagrammed in Appendix 1. 
Prior to conducting any study-related activities, written informed consent and the Health 
Insurance Portability must be signed and dated by the subject. 
 
9.1 
Clinical Assessments 
9.1.1 
Concomitant Medications 
Inapplicable, participants should be healthy. 
9.1.2 Demographics  
Demographic information (date of birth, gender, income, education, professional 
status, and social status) will be recorded at screening.
 
9.1.3 Medical History  
Relevant medical history will be recorded at Screening. 

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9.1.4 
Physical Examination 
A complete physical examination will be performed by co-investigator who is a physician 
at Visit 1.  Qualified staff (MD, NP, RN, and PA) may complete the abbreviated physical 
exam at next visit.   
9.1.5 
Vital Signs 
Body temperature, blood pressure, pulse and respirations will be performed after resting 
for 5 minutes at Visits 1 &2. 
9.1.6 
Oximetry 
Inapplicable 
9.1.7 
Spirometry 
Inapplicable 
9.1.8 
Other Clinical Procedures 
Inapplicable 
9.1.9 
Adverse Events 
Information regarding occurrence of adverse events will be captured throughout the study. 
Duration (start and stop dates and times), severity/grade, outcome, treatment and relation 
to the supplementation will be recorded on the case report form (CRF). 
9.2 
Clinical Laboratory Measurements (include sections as appropriate) 
9.2.1 
Hematology 
Inapplicable 
9.2.2 
Blood Chemistry Profile 
The blood analysis including glycated hemoglobin (HA1c) and lipid profile (TC, HDL-C, 
and TG). Other blood analysis include: LPS, Aspartate Transaminase (AST), Alanine 
transaminase (ALT), superoxide dismutase (SOD), catalase, and glutathione peroxidase 
(GPx). 
9.2.3 
Pregnancy Test 
Inapplicable 
9.2.4 
Urinalysis 
Inapplicable 

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9.3 
Pharmacokinetic Measurements 
All analyses will be done in the CBCD, KSU using colorimetric method. Regular 
blood analysis will be taken at baseline and at the end of the study, then are kept into plan 
red covered tubes. All blood samples will be centrifuged (3500 × 5 mins) to separate serum 
samples. All tubes should be placed vertically for 45 minutes until the sample is completely 
coagulated, then transported to CBCD, KSU for further analysis.  
9.4 
Research Laboratory Measurements (include sections as appropriate) 
Inapplicable 
9.4.1 
Cell Count and Differential 
Inapplicable 
9.4.2 
Sputum Cytokine Measurements 
Inapplicable 
10 EVALUATIONS BY VISIT 
10.1 Visit 1 in the beginning of study: 
1. 
Review the study with the subject and obtain written informed consent. 
2. 
Assign the subject a unique screening number. 
3. 
Record demographics data. 
4. 
Record medical history, including:  
• 
Stability of weight in the last three months prior the study. 
• 
Having any of the following diseases: Thyroid disorders, Diabetes type-1, 
Diabetes type-2, (Any type of disease) Cancer, Neurological disorders, 
psychiatric disorders, or other. 
• 
Having any of weight loss surgeries. 
• 
Enrolling in any diet during the past three weeks. 
• 
Taking antibiotics in the past 3 weeks. 
• 
Taking any probiotic supplements regularly for the past 3 months. 
• 
For ladies: 
 -Are you planning to become pregnant in the next three months? 
- Are you taking any hormonal therapy? 
5. 
Perform a complete physical examination. 
6. 
Explain the possible side effect. 
7. 
Perform and record results of blood pressure testing. 
8. 
Collect blood for clinical laboratory. 
9. 
Allocation process which includes randomizing the participants in two groups and 
allocation concealment. 
10. Taking food frequency record for probiotics & prebiotics. 
11. Taking 24-hour record. 

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12. Taking anthropometric measurements. 
13. Taking physical activities. 
10.2 Visit 2 at the end of the study (3 months length) 
1. 
Perform an abbreviated physical examination 
2. 
Perform and record results of blood pressure testing. 
3. 
Collect blood for clinical laboratory. 
4. 
Taking 24-hour record 
5. 
Taking anthropometric measurements. 
6. 
Taking physical activities. 
10.3 Early Withdrawal Visit 
1. 
Record any Adverse Experiences and/or review subject diary for adverse 
experiences and exclusionary medication use. 
2. 
Record changes to concomitant medications. 
3. 
Perform complete physical examination. 
4. 
Perform and record vital signs. 
11 ADVERSE EXPERIENCE REPORTING AND DOCUMENTATION 
11.1 Adverse Events 
In general, using probiotic products may cause mild bowel discomfort and diarrhea in the 
first few days or maximum one week for some people. All these symptoms will disappear 
later. 
AE Severity 
Probiotic products are considered over the counter drugs (OTC) which don’t require  
doctor's prescription. Many clinical trials proved that Hexbio product doesn't cause any 
AE severity, that clearly explained in investigator's brochure. However, participant can 
stop participating at any time, recording reasons as possible. 
 
AE Relationship to Study Drug 
AE include possible bowel discomfort and mild diarrhea. 
 
11.2 Serious Adverse Experiences (SAE) 
Using probiotic products doesn't cause any SAE. 

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11.2.1 Serious Adverse Experience Reporting 
Probiotic products are safe, however, if there are any SAEs, they will be documented 
(whether related to study drug or not).  The collection period for all SAEs will begin after 
informed consent is obtained and end after procedures for the final study visit have been 
completed. 
In accordance with the standard operating procedures and policies of the local Institutional 
Review Board (IRB), the site investigator will report SAEs to the IRB.   
11.3 Protocol Defined Important Medical Findings Requiring Real Time Reporting 
Inapplicable 
11.4 Medical Monitoring 
Dr. Mariam Eid Al- Juhani should be contacted directly at these numbers to report 
medical concerns or questions regarding safety. 
Phone: 0581444264 
   
12 DISCONTINUATION AND REPLACEMENT OF SUBJECTS 
12.1 Early Discontinuation of Study Drug  
A subject may be discontinued from study treatment at any time if the subject, the 
investigator, or the Sponsor feels that it is not in the subject’s best interest to continue.  
The following is a list of possible reasons for study treatment discontinuation:  
1. Subject withdrawal of consent (or assent) 
2. Subject is not compliant with study procedures 
3. Adverse event that in the opinion of the investigator would be in the best interest 
of the subject to discontinue study treatment 
4. Protocol violation requiring discontinuation of study treatment 
5. Lost to follow-up 
6. Sponsor request for early termination of study 
7. Positive pregnancy test (females) 
If a subject is withdrawn from treatment due to an adverse event, the subject will be 
followed and treated by the Investigator until the abnormal parameter or symptom has 
resolved or stabilized.   

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All subjects who discontinue study treatment should come in for an early discontinuation 
visit as soon as possible and then should be encouraged to complete all remaining 
scheduled visits and procedures. 
All subjects are free to withdraw from participation at any time, for any reason, specified 
or unspecified, and without prejudice. 
Reasonable attempts will be made by the investigator to provide a reason for subject 
withdrawals.  The reason for the subject’s withdrawal from the study will be specified in 
the subject’s source documents. 
12.3 
Withdrawal of Subjects from the Study 
A subject may be withdrawn from the study at any time if the subject, the investigator, or 
the Sponsor feels that it is not in the subject’s best interest to continue.   
All subjects are free to withdraw from participation at any time, for any reason, specified 
or unspecified, and without prejudice. 
Reasonable attempts will be made by the investigator to provide a reason for subject 
withdrawals.  The reason for the subject’s withdrawal from the study will be specified in 
the subject’s source documents.  As noted above, subjects who discontinue study 
treatment early (i.e., they withdraw prior to Visit 2) can have an early discontinuation 
visit.  
 
12.4 Replacement of Subjects 
Subjects who withdraw from the study treatment will not be replaced.   
Subjects who withdraw from the study will not be replaced.   
 
13 PROTOCOL VIOLATIONS 
A protocol violation occurs when the subject, investigator, or Sponsor fails to adhere to 
significant protocol requirements affecting the inclusion, exclusion, subject safety and 
primary endpoint criteria.  Protocol violations for this study include, but are not limited to, 
the following: 
1. Failure to meet inclusion/exclusion criteria 
2. Use of a prohibited concomitant medication 
3. Not follow the role, (for example do not follow the health guideline). 
4. Not use the probiotic according to the description. 
Failure to comply with Good Clinical Practice (GCP) guidelines will also result in a 
protocol violation. The Sponsor will determine if a protocol violation will result in 
withdrawal of a subject. 

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When a protocol violation occurs, it will be discussed with the investigator and a Protocol 
Violation Form detailing the violation will be generated. This form will be signed by a 
Sponsor representative and the Investigator. A copy of the form will be filed in the site’s 
regulatory binder and in the Sponsor’s files. 
14 DATA SAFETY MONITORING (OPTIONAL SECTION – INCLUDE WHEN 
APPROPRIATE) 
Inapplicable 
15 STATISTICAL METHODS AND CONSIDERATIONS 
The primary outcome of this study is the difference in waist circumference 
between groups after 12 weeks of supplementation. The analysis of this study 
will include all the patients using intention to treat (ITT) methodology. Waist 
circumference of two groups after 12 weeks of supplementation will be 
examined for statistical significant using repeated measures ANOVA. 
 
15.1 Data Sets Analyzed 
All eligible subjects will be included in each analysis. 
15.2 Demographic and Baseline Characteristics 
Demographic information (date of birth, gender, income, education, professional 
status, and social status) will be recorded at screening.
 
15.3 Analysis of Primary Endpoint 
ANOVA 
15.4 Analysis of Secondary Endpoints 
ANOVA 
15.5 Interim Analysis 
All analysis will be done at the end of the intervention. 
15.6 Sample Size and Randomization 
The study population depends on the study result of Gomes and his colleagues who used 
the G-Power software (version 3.0.10) to calculate the sample size. The primary outcome 
in that study is the difference in waist circumference between groups. The power 
calculation requires 17 participants in each group (95% power; 5% type I error) to detect a 
difference in waist circumference (Gomes et al, 2018). In this study, to avoid any later 
drop-off, both groups will be set to have 45 participants. 

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16 DATA COLLECTION, RETENTION AND MONITORING 
16.1 Data Collection Instruments 
The Investigator will prepare and maintain adequate and accurate source documents 
designed to record all observations and other pertinent data for each subject treated with the 
study drug.   
Study personnel at each site will enter data from source documents corresponding to a 
subject’s visit into the protocol-specific electronic, Case Report Form (eCRF) and paper 
CRF when the information corresponding to that visit is available.  Subjects will not be 
identified by name in the study documents to be collected by the Sponsor (or designee) 
but will be identified by a subject number. 
For eCRFs: If a correction is required for an eCRF, the time and date stamps track the 
person entering or updating eCRF data and creates an electronic audit trail.  For paper 
CRFs:  If a correction is made on a CRF, the study staff member will line through the 
incorrect data, write in the correct data and initial and date the change. 
The Investigator is responsible for all information collected on subjects enrolled in this 
study.  All data collected during the course of this study must be reviewed and verified for 
completeness and accuracy by the Investigator 
Data Management Procedures 
The data will be kept in paper documents and e-documents, the study doesn't have 
database. 
16.2 Data Quality Control and Reporting 
Inapplicable 
16.3 Archival of Data 
All data will be kept in both: 
 Electronic documents, in which can be reached by principal investigator and other 
investigators only. 
  Paper documents which can be kept in a locked file cabinet until 2 years at least after the 
study, then they will be disposed. 
16.4 Availability and Retention of Investigational Records 
The Investigator must make study data accessible to the monitor, other authorized 
representatives of the Sponsor (or designee), as IRB and S FDA, inspectors upon request.  
A file for each subject must be maintained that includes the signed Informed Consent, and 
copies of all source documentation related to that subject.  The Investigator must ensure 
the reliability and availability of source documents from which the information on the 
CRF was derived. 

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All study documents (patient files, signed informed consent forms, copies of CRFs, Study 
File Notebook, etc.) must be kept secured for a period of two years following study.  
There may be other circumstances for which the Sponsor is required to maintain study 
records and, therefore, the Sponsor should be contacted prior to removing study records 
for any reason. 
16.5 Monitoring 
Appropriate regulatory authorities, such as the SFAD and Clinic Manager, may conduct 
monitoring visits to conduct on-site monitoring and/or audits of all appropriate study 
documents. 
16.6 Subject Confidentiality 
In order to maintain subject confidentiality, only a site number, subject number and 
subject initials will identify all study subjects on CRFs and other documentation submitted 
to the Sponsor.  Additional subject confidentiality issues (if applicable) are covered in the 
Clinical Study Agreement. 
17 ADMINISTRATIVE, ETHICAL, REGULATORY CONSIDERATIONS 
To maintain confidentiality, all laboratory specimens, evaluation forms, reports and other 
records will be identified by a coded number and initials only.  All study records will be 
kept in a locked file cabinet and code sheets linking a patient’s name to a patient 
identification number will be stored separately in another locked file cabinet.  Clinical 
information will not be released without written permission of the subject, except as 
necessary for monitoring by the SFDA.  The Investigator must also comply with all 
applicable privacy regulations. 
17.1 Protocol Amendments 
Any amendment to the protocol will be written by the Sponsor.  Protocol amendments 
cannot be implemented without prior written IRB approval except as necessary to 
eliminate immediate safety hazards to patients.  A protocol amendment intended to 
eliminate an apparent immediate hazard to patients may be implemented immediately, 
provided the IRBs are notified within five working days. 
17.2 Institutional Review Boards and Independent Ethics Committees 
The protocol and consent form are reviewed and approved by the IRB prior to study 
initiation.  Serious adverse experiences regardless of causality will be reported to the IRB 
in accordance with the standard operating procedures and policies of the IRB, and the 
Investigator will keep the IRB informed as to the progress of the study.  The Investigator 
will obtain assurance of IRB compliance with regulations. 
Any documents that the IRB may need to fulfill its responsibilities (such as protocol, 
protocol amendments, Investigator’s Brochure, consent forms, information concerning 
patient recruitment, payment or compensation procedures, or other pertinent information) 

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will be submitted to the IRB.  The IRB written unconditional approval of the study 
protocol and the informed consent form will be in the possession of the Investigator 
before the study is initiated.  The IRB unconditional approval statement will be 
transmitted by the Investigator to the Sponsor or designee prior to the shipment of study 
supplies to the site.  This approval must refer to the study by exact protocol title and 
number and should identify the documents reviewed and the date of review. 
Protocol and/or informed consent modifications or changes may not be initiated without 
prior written IRB approval except when necessary to eliminate immediate hazards to the 
patients or when the change(s) involves only logistical or administrative aspects of the 
study.  Such modifications will be submitted to the IRB and written verification that the 
modification was submitted and subsequently approved should be obtained.   
The IRB must be informed of revisions to other documents originally submitted for 
review; serious and/or unexpected adverse experiences occurring during the study in 
accordance with the standard operating procedures and policies of the IRB; new 
information that may affect adversely the safety of the patients of the conduct of the study; 
an annual update and/or request for re-approval; and when the study has been completed. 
17.3 Informed Consent Form  
The Investigator will prepare the informed consent form and provide the documents to the 
Sponsor or designee for approval prior to submission to the IRB.  The consent form 
generated by the Investigator must be acceptable to the Sponsor and be approved by the 
IRB.  The written consent document will embody the elements of informed consent as 
described in the International Conference on Harmonisation and will also comply with 
local regulations. The Investigator will send an IRB -approved copy of the Informed 
Consent Form to the Sponsor (or designee) for the study file. 
A properly executed, written, informed consent will be obtained from each subject prior to 
entering the subject into the trial.  Information should be given in both oral and written 
form and subjects must be given ample opportunity to inquire about details of the study.  
If appropriate and required by the local IRB, assent from the subject will also be obtained.  
A copy of the signed consent form will be given to the subject or legal representative of 
the subject and the original will be maintained with the subject’s records. 
17.4 Publications  
The preparation and submittal for publication of manuscripts containing the study results 
shall be in accordance with a process determined by mutual written agreement among the 
study Sponsor and participating institutions.  The publication or presentation of any study 
results shall comply with all applicable privacy laws.  
17.5 Investigator Responsibilities 
By signing the Agreement of Investigator form, the Investigator agrees to: 

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1. Conduct the study in accordance with the protocol and only make changes after 
notifying the Sponsor (or designee), except when to protect the safety, rights or 
welfare of subjects. 
2. Personally conduct or supervise the study (or investigation). 
3. Ensure that the requirements relating to obtaining informed consent and IRB review 
and approval meet federal guidelines. 
4. Report to the Sponsor or designee any AEs that occur in the course of the study. 
5. Ensure that all associates, colleagues and employees assisting in the conduct of the 
study are informed about their obligations in meeting the above commitments. 
6. Maintain adequate and accurate records and to make those records available for 
inspection with the Sponsor (or designee). 
7. Ensure that an IRB that complies with the. 
8. Promptly report to the IRB and the Sponsor (or designee) all changes in the research 
activity and all unanticipated problems involving risks to subjects or others (to 
include amendments and IND safety reports). 
9. Seek IRB approval before any changes are made in the research study, except when 
necessary to eliminate hazards to the patients/subjects. 
10. Comply with all other requirements regarding the obligations of clinical investigators 
and all other pertinent requirements. 
 

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APPENDIX 1.  EXAMPLE OF SCHEDULE OF STUDY VISITS 
 
VISIT 1 
(Day/Week/Month #)a 
VISIT 2 
(Day/Week/Month #)a 
Informed Consent 
X 
 
Medical History 
X 
 
Complete Physical Exam 
X 
 
Abbreviated Physical Exam 
 
X 
Height  
X 
X 
Weight  
X 
X 
Vital Signs  
X 
X 
Oximetry 
 
 
Spirometry 
 
 
Pharmacokinetics 
 
X 
Chemistry 
X 
X 
Pregnancy Test (Urine or Serum)  
 
 
Hematology 
 
 
ESR 
 
 
C-Reactive Protein 
 
 
Urinalysis 
 
 
Randomization 
X 
 
Dispensing or Administration of 
Study Drug 
X 
X 
Counting of Returned Study Drug 
 
X 
Initiate Subject Diary 
X 
 

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Subject Diary Review 
 
X 
Concomitant Medication Review 
X 
X 
Adverse Experiences 
 
 
a  
±2 days

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Protocol Template © CFFT TDN   Effective: 12 SEP 2007 
Required Components of Informed Consent 
 
Informed consent is not a single event or just a form to be signed; it is an educational 
process that takes place between the investigator and the prospective subject. The basic 
elements of the consent process include:  
full disclosure of the nature of the research and the participant's involvement, 
adequate comprehension on the part of the potential participant, and 
the participant's voluntary choice to participate. 
 
It is the investigator’s responsibility to document that the informed consent process has 
taken place, and an informed consent form is the standard for documenting the process for 
research projects involving human participants.  
 
Consent forms must contain all the required components of informed consent as defined in 
SOP 9: Informed Consent Options, Processes, and Documentation and summarized below. 
The consent form must be written in language that is easy for a potential participant to 
understand and assures that individual’s comprehension. Therefore, avoiding technical 
terms and complex sentences, even for the educated layperson, is very important.  
 
When the participant population is not homogeneous, different consent documents may be 
required for different groups of people. If the research population will include participants 
under 18 years of age, then the IRB will expect investigators to use an assent form and a 
parental permission form instead (see SOP 11: Informed Consent, Enrollment, and Other 
Considerations for Research Involving Children). Similarly, research with cognitively or 
decisionally impaired individuals will require documented consent from another party—
namely that person’s legally authorized representative (see SOP 9, section 8 and/or SOP 
10: xxx).  
 
The IRB also recognizes that there are instances when documenting written informed 
consent is not appropriate to a research project. Alternatives to using a signed form for 
documenting informed consent are detailed in SOP 9.  
 
Regardless of the method of documenting informed consent, however, the process of 
obtaining informed consent should always contain the same required components.  
 
Helpful guidelines for constructing an effective consent form:  
Use common, ordinary language instead of technical, academic terms. Ideally we would 
like consent forms to be written an 8th grade reading level. A helpful gage is to consider if 
one’s 13 year-old cousin would be able to understand the research after reading the consent 
form. 
Try to keep the sentences as short and simple as possible. Write in the second person using 
you/your pronouns. For example: "You are being asked to participate in a research 
project…," "If you have questions later, you may contact…," or "You will be given a copy 
of this form to keep for your records." 

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Protocol Template © CFFT TDN   Effective: 12 SEP 2007 
Do not use assumptive statements such as "You understand that ..." or "You have been told 
that...." 
Use adequate white space so that the form is easy to read, and avoid using small fonts to 
squeeze all the text onto one page. 
Headings for paragraphs are helpful and make the form easier to read and understand. 
 
 
Required Elements of Informed Consent Forms:  
1. A clear, concise explanation of the purposes of the research, including the name of the 
study and prominent use of the term "research." (Note: the IRB can waive this element if 
the study requires deception. In such cases, a debriefing statement should also be used to 
inform participants at an appropriate time after their involvement in the study.)  
2. An explanation of what will be happening to the participant during the study, and an 
indication of the participant's time commitment for each component.  
3. Description of the risks, side effects or discomforts of the study procedures. For instance, 
even though it is not considered a risky procedure, a needle stick to draw blood may cause 
brief pain or discomfort. For social science and behavioral research, though risks usually do 
not extend beyond the possible loss of confidentiality and/or mild emotional distress, these 
should also be made clear to prospective participants.  
 
 If it appears that there are no real risks to participation, state, "We do not anticipate any 
risks to you participating other than those encountered in daily life." Please see our Sample 
Consent Form for an example of appropriate wording of a risk statement.  
4. Description of any potential benefits from participating.  
 
 For individual participants, these should be limited to direct benefits: information about 
better coping skills, awareness of available support or resources, or any other personal gain 
other than financial rewards. (Learning about how experiments are conducted, receiving a 
gift, or earning extra credit for being a research participant are NOT recognized as benefits. 
Gifts, extra credit for courses, and reimbursement for expenses are considered 
compensation.) If there are no direct benefits, simply indicate that there are none.  
 
 For indirect benefits to society or scientific knowledge, statements such as "…information 
from this study may benefit other people now or in the future…" or "…we hope to learn 
more about ________ …" are appropriate.  
5. A statement that the participant's involvement is voluntary, the participant may refuse to 
participate before the study begins, discontinue at any time, or skip any questions that may 
make him/her feel uncomfortable, with no penalty to him/her, and no effect on the 
compensation earned before withdrawing, or their academic standing, record, or 
relationship with the university.  
6. A statement that the participant is allowed to ask questions concerning the study, both 
before agreeing to be involved and during the course of the study. See required contact 
information in #11 below.  
7. A description of how the participant's confidentiality will be protected.  
8. A description of what will be done with the data once the study is completed.  

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9. An indication that recording devices, audio or visual, are being used (when applicable).  
 
 Be sure to describe what will be done with the any video or audio tapes upon the 
completion of the study (destroyed, erased, archived, etc.), and when (after transcription, 3 
years, 5 years, etc.).  
 
 Also, provide a separate signature line on the consent form for the participant to agree to 
be video/audio taped or photographed, if the recording is optional for participation. For 
example:  
 
 Please sign below if you are willing to have this interview recorded on tape (specify audio 
or video). You may still participate in this study if you are not willing to have the interview 
recorded.  
 
 I am willing to have this interview recorded on tape:  
 
 Signed: __________________________________________  
 
 Date: ____________________________________________  
10. An indication that the participant shall receive a copy of the signed and dated consent 
form.  
11. The name(s) of the investigator(s) and contact information.  
12. An indication that the participant may contact the Institutional Review Board for 
Human Participants (IRB) with any concerns or complaints. Additionally, a statement 
indicating that participants can report their concerns or complaints anonymously through.  
13. A "statement of consent" and the name and signature of the participant.  
14. The name signature of the person obtaining consent.  
15. At the bottom of the form the following statement: "This consent form will be kept by 
the researcher for at least three years beyond the end of the study and was approved by the 
IRB on [date]."