The Effect of an Intestinal Adsorbent on Hydrogen and Methane Breath Testing, in Patients With Abdominal and Reflux Symptoms, on Long Term Proton Pump Inhibitor Therapy
Phase: NA
Conditions: Gastroesophageal Reflux, Small Intestinal Bacterial Overgrowth
Sponsor: Dr Anthony Hobson

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The Functional Gut Clinic 
22 Upper Wimpole Street 
London 
W1 G 6NB 
Phone: + 44 (0)207 486 7777 
Fax: + 44 (0)20 7224 1486 
Mobile: +44 (0)7850114966 
Email: admin@thefunctionalgutclinic.com 
 
Principle Investigator – Dr Anthony R. Hobson Ph.D. - Consultant Clinical Scientist 
 
 
 
Pilot Study – The effect of an intestinal adsorbent on hydrogen and methane 
breath testing, in patients with abdominal and reflux symptoms, on long 
term proton pump inhibitor therapy  
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Title of Study 
The effect of an intestinal adsorbent on hydrogen and methane breath testing, in patients with 
abdominal and reflux symptoms, on long term PPI therapy  
 
Study Sites 
The Functional Gut Clinic Manchester – 9th Floor, 73-79 King Street, Manchester, M2 4NG 
 
Objective  
To determine the effect of Silicolgel on hydrogen and methane breath testing in patients on long 
term PPI therapy with reflux and abdominal symptoms.  
 
Methodology 
This protocol describes a pilot study, using an uncontrolled, open label single-armed design, 
consisting of two distinct periods (pre-treatment and treatment). Participants visiting a 
gastroenterologist at The Functional Gut Clinic or recruited through advertising on social media 
platforms should be eligible for the study as long as they have no concomitant exclusionary 
disease and meet inclusion criteria for the study.  
This pilot study will be used to explore the question outlined in the objective and to determine the 
feasibility of carrying out a larger randomised controlled trial   
 
Study timeline 
 
 
 
 
 
 
 
 
Background 
Proton pump inhibitors (PPIs) are the most commonly prescribed drugs worldwide and have 
shown impressive efficacy in the reduction of oesophageal mucosal damage associated with 
GORD and symptoms relating to GORD (1, 2). There is, however, growing evidence to show a 
large percentage of patients receiving long term PPI therapy, develop IBS type symptoms such as 
abdominal discomfort, pain, bloating, belching and altered bowel habit (3, 4). It has been proposed 
that the development of these symptoms may be linked to shifts in the location, concentration and 
species of gastrointestinal micro flora. Inhibition of gastric acid secretion, through PPI therapy, has 
been linked to small intestinal bacterial overgrowth in several studies (5-7). A meta-analysis 
interrogating the relationship between PPI use and SIBO, confirmed there was a significant 
relationship between PPI therapy and SIBO (8).  
 
Recruitment 
Screening 
Informed consent 
Low residue diet 
HMBT  
Baseline questionnaires 
Days 2-11 
 
 
Day 0 
Day 1 (visit 1) 
Pre-enrolment 
Silicolgel three times daily 
HMBT 
End of study questionnaires 
Day 12 (visit 2) 
Low residue diet 
Pre-treatment period 
        Treatment Period 
              
Treatment period 

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Figure 1 : Symptom pattern change in long term PPI users (*P<0.05, **p<0.01, ***p<0.001) (4).   
SIBO is by definition a concentration of  ≥1 × 105 coliform bacteria cfu per ml from a jejunal aspirate, 
however there is debate whether 1 × 103 cfu/ml may be more appropriate to define SIBO (9). Jejunal 
aspirate as a method of diagnosis is however expensive and highly invasive, therefore hydrogen and 
methane breath testing (HMBT) is most commonly used to diagnose SIBO in the clinical setting. HMBT 
utilises the gases produced by intestinal microflora to determine whether SIBO or dysbiosis is present 
in a patient. These microbiota not only produce gases during fermentation of ingested sugars, but 
other waste products, such as water and short chain fatty acids, which can alter conditions in the small 
bowel, causing troublesome abdominal symptoms (10).  
Silicolgel is a liquid gel containing silicon dioxide as hydrated silicic acid in a colloidal form. The particles 
of polymeric Silicic acid are highly adsorptive due to large particle surface area and negatively charged 
surface hydroxyl groups. This allows Silicolgel, when ingested, to encompass large volumes of 
intestinal gases, inorganic molecules, water and organic molecules such as the waste products of 
bacterial fermentation. The efficacy of Silicolgel has been demonstrated in an (unpublished) study by 
Dr Erling Thom -Medstat Research, Lillestrom, Norway. Also an observational study of Silicea gel, a 
medical device with almost identical formulation to Silicolgel, demonstrated a significant reduction in 
both upper and lower abdominal symptoms  over a 6 week treatment period (11). 
This study has been designed to establish whether Silicolgel effects HMBT values and upper and lower 
GI symptoms, in patient’s on long term PPIs, with persistent reflux and abdominal symptoms.  
Proposed timeline 
 6-months to complete recruitment and lab analysis. 
Ethical Considerations 
The study will be submitted to the Greater Manchester Research Ethics Committee (REC) for approval. 
Proposed budget 
40 lactulose HMBT tests and analysis (£10,000); Administrative costs for writing and submitting 
regulatory approvals + calling patients, sending out kits and questionnaires £1000 – Total costs - 
£11,000 

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Statistical Methods 
Sample size calculation: As this is a pilot study to determine proof of concept, a sample size of 20 will 
be used.  
Statistical analysis:  
Primary outcome: Mean change in cumulative total breath hydrogen and methane, from baseline 
HMBT to end of study HMBT, will be calculated statistically using 2 tailed Paired T-test.  
Secondary outcomes:  
• 
Difference between baseline and end of study IBS-SSS scores will be calculated statistically 
using 2 tailed Paired T-test.  
• 
Difference between baseline and end of study reflux scores will be calculated statistically using 
2 tailed Paired T-test.  
• 
Change in bowel habit and abdominal symptoms from baseline to end of study as measured 
by daily bowel diaries 
Study Timelines 
Recruitment 
Participants will be recruited through gastroenterology clinics at the Functional Gut Clinic as well as 
through advertisement on several social media platforms. If potential participants register interest, 
they will be provided with a patient information sheet and consent form to review for at least 24 
hours. A screening questionnaire will be carried out to establish whether they are eligible to enter the 
study. If participants are eligible and have reviewed the study information, they will be enrolled into 
the study on giving a signature of informed consent.  
Day 0  
Once participants have enrolled on the study, they will arrange a date to visit the clinic to complete a 
hydrogen and methane breath test (HMBT), the test will be completed on day 1. The day before the 
trial, day 0, the participant will be required to follow a specific low residue diet as part of breath 
testing preparation (appendix 1).  
Day 1  
On day 1 of the trial, participants will visit The Functional Gut Clinic (FGC) to complete a HMBT 
following FGC protocol (appendix 2). Participants will also be asked to complete a Reflux 
questionnaire (appendix 3), IBS-SSS questionnaire (appendix 4) and Bristol stool questionnaire 
(appendix 5). Following completion of the HMBT and questionnaires, participants will be given a 10 
day supply of the blinded product Silicolgel and provided with instructions on how to use the 
product (appendix 6).  
Day 2-11 
Participants will be asked to commence ingestion of Silicolgel on study days 2 – 11, as per 
instructions. Participants will take 15ml of Silicolgel three times daily, 1 hour before meals. On day 
11 participants will be required to complete a low residue diet in preparation for HMBT on day 12. 

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Day 12 (end of study visit) 
Participants will visit The Functional Gut Clinic (FGC) to carry out a repeat HMBT following FGC 
protocol (appendix 2). Participants will also be asked to repeat the Reflux questionnaire (appendix 
3), IBS-SSS questionnaire (appendix 4) and bowel habit questionnaire (appendix 5). Completion of 
the repeat breath test and questionnaires will mark the end of the study for the patient. 
 
Eligibility  
 
Inclusion Criteria 
 
1. Participant has provided written informed consent before participating in the study after 
being given a full description of the study and prior to any study-specific procedures being 
performed. 
2. Patient has been taking PPI therapy for >6 months 
3. Patient reports bloating ≥3 on screening questionnaire 
4. Patient reports one of the following ≥3 on screening questionnaire - belching, heartburn, 
nausea, reflux sensation  
5. Participant is a male or non-pregnant female and is age 18 years of age or above  
6. Participant is able to communicate well with the Investigator and to comply with the 
requirements for the entire study. 
7. Patient has capacity to understand written English  
8. Patient agrees to follow pre-test diet for 24 hours before giving test sample (Appendix A). 
9. Participant agrees to refrain from strenuous physical activity on the day of the breath test.  
10. Participant agrees to refrain from smoking on the day of the breath test 
11. Participant agrees to an overnight fast on the night before the breath test. Food and drink 
must be withheld until after all breath test samples have been taken. 
12. Participant agrees to not take any probiotic for 7 days before the breath test. 
13. Participant has a body mass index (BMI) between 18.5 and 34.9kg/m2 (bounds included). 
 
Exclusion criteria 
 
1. Participant reports using any prohibited medication, medical device or supplementation 
2. Participant has taken antibiotics or undergone colonoscopy/sigmoidoscopy in the 4 weeks 
prior to enrolment.  
3. Participant has a diagnosis of any organic gastrointestinal disease, including inflammatory 
bowel disease, coeliac disease and diverticulitis.  
4. Participant has known mechanical obstruction of the GI tract 
5. Participant has diabetes 
6. Participant has any hepatic disease  
7. Participant has any disease of the CNS 
8. Participant is involved in this study as an Investigator, sub-Investigator, study coordinator, 
other study staff, or Sponsor member. 
9. Participant has had previous abdominal or colorectal surgery except appendectomy, 
cholecystectomy, or hysterectomy. 
10. Participant has previously taken Silicolgel in the past month 
11. Participant has a known hypersensitivity to any of the ingredients of Silicolgel  
12. Participant suffers regularly from constipation 

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13. Participant is involved in any other research projects either currently or during the   previous 
month  
 
 
Test Product, Planned Doses, Mode of Administration and duration of treatment 
 
Silicolgel 15ml, oral administration. Total Participation is expected to last 12 days, with a 10-day 
treatment period. During the treatment period participants will take 15ml Silicolgel three times 
daily. Silicolgel should be taken one hour before meals. Silicolgel may be taken undiluted or diluted 
with water. Due to its inability to be absorbed into the blood stream and physical not 
pharmacological mechanism, SIlicolgel is considered a class IIa medical device according to the 
Medical Device Directive 93/42/EEC Annex rule 5. 
 
The bottle must be shaken before each administration. The bottle of Silicolgel should be stored 
above 2⁰C. After opening the bottle, the product should be consumed within 3 months, and it should 
not be used after the date given on the label.  
 
 
Blinding procedure 
 
All participants will be blinded to the study device. Silicolgel bottles will be labelled without any 
Silicolgel branding or product ingredients. Study participants will be made aware that the product is 
a CE marked medical device that works via intestinal adsorption. Any potential side effects of the 
product will also be disclosed to the patient.  
  
 
Study Outcome Assessments 
 
Primary outcome assessment 
 
Mean change in cumulative total breath hydrogen and methane, will be determined from baseline 
HMBT to end of study HMBT. Cumulative total hydrogen and cumulative total methane will be 
calculated independently of one each other. Breath hydrogen and breath methane will be measured 
in units of parts per million (ppm). Statistical significance will be determined using a paired t-test 
(p<0.05).  
Each HMBT samples will be analysed using gas chromatography analysis on the day of the breath 
test being carried out. Breath carbon dioxide will also be measured in order to verify the validity of 
each sample and apply a correction factor. A correction factor above 2.5 (CO2 < 2%) is considered an 
invalid sample.  
 
Secondary outcome assessment 
 
Reflux Questionnaire (Appendix 3) 
 
The Reflux Questionnaire is a validated questionnaire that will be used to determine severity of 
upper GI symptoms. The questionnaire is made up of 16 questions, each scored 0 to 5. The total of 
these 16 questions will be calculated to determine symptom severity. Mean difference in scores 
from baseline reflux questionnaire and end of study reflux questionnaire will be determined using a 
paired t-test, to determine significance (p<0.05). 

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Irritable Bowel Syndrome Symptom Severity Score (IBS-SSS) (Appendix 4) 
 
The IBS-SSS is a validated questionnaire that will be used to determine severity of abdominal and 
bowel symptoms. The questionnaire is comprised of 7 questions, 5 of which are scored from 0 to 10. 
The total of these 5 questions will be calculated and multiplied by 10 to determine symptom 
severity. Mean difference in scores from baseline IBS-SSS and end of study IBS-SSS will be 
determined using a paired t-test, to determine significance (p<0.05).  
 
 
 
Bristol stool chart (Appendix 5) 
 
The Bristol stool chart will be used by participants stool frequency and consistency. Participants will 
be asked to identify their stool type during the past 7 days using the chart and describe their stool 
frequency. Mean difference in stool frequency and consistency from baseline and end of study will 
be determined using a paired t-test, to determine significance (p<0.05).  
 
Safety Outcome Assessments 
 
Definitions 
 
Types of AEs associated with medical devices and applicable for this study are defined in accordance 
with the European Commission guidelines on medical devices. 
 
Adverse events 
 
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs 
(including an abnormal laboratory finding) in subjects, users or other persons whether or not related 
to the investigational medical device.   
 
NOTE 1: This includes events related to the procedures involved (any procedure in the clinical 
investigation plan).   
NOTE2: For users or other persons this is restricted to events related to the investigational medical 
device.   
 
Adverse Device Effect (ADE)   
  
AE related to the use of an investigational medical device.  
 
NOTE 1: This includes any AE resulting from insufficiencies or inadequacies in the instructions for 
use, the deployment, the implantation, the installation, the operation, or any malfunction of the 
investigational medical device.  
NOTE 2: This includes any event that is a result of a use error or intentional misuse 
 
 
Serious Adverse Device Effect (SADE)   
 
Adverse device effect that has resulted in any of the consequences characteristic of a serious AE. 
 
Serious Adverse Event  

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AE that: 
 a) led to a death,  
b) led to a serious deterioration in health that either:   
1. resulted in a life-threatening illness or injury, or  
2. resulted in a permanent impairment of a body structure or a body function, or  
3. required in-patient hospitalisation or prolongation of existing hospitalisation, or  
4. resulted in medical or surgical intervention to prevent life threatening illness or injury or 
permanent impairment to a body structure or a body function.   
c) led to foetal distress, foetal death or a congenital abnormality or birth defect.   
  
NOTE 1: This includes device deficiencies that might have led to a SAE if a) suitable action had not 
been taken or b) intervention had not been made or c) if circumstances had been less fortunate. 
These are handled under the SAE reporting system.  
 
NOTE 2: A planned hospitalisation for pre-existing condition, or a procedure required by the Clinical 
Investigation Plan, without a serious deterioration in health, is not considered to be a SAE. 
 
 
 
Unanticipated Serious Adverse Device Effect (USADE)   
  
Serious adverse device effect which by its nature, incidence, severity or outcome has not been 
identified in the current version of the risk analysis report or product safety information.  
 
NOTE: Anticipated: an effect which by its nature, incidence, severity or outcome has been previously 
identified in the risk analysis report 
 
Expected Adverse Events and Adverse Events of Special Interest  
  
According to the standard Package Information Leaflet, SIlicolgel does not have any known side 
effects or adverse events.  
 
 
Reporting and reporting of adverse events 
 
Investigational procedures and treatment  
  
AEs will be collected throughout the study from screening visit until week 24. If an AE is reported by 
the patient, the relationship of the event to the study treatment or procedures should be assessed 
by the local PI, or a delegated sub-PI or nurse. The following information will be recorded for all AEs:  
  
• 
Medical term of the AE (SNOMED CT terminology) 
 
 
 
 
• 
 Start date and date of resolution  
• 
Seriousness  
• 
Severity  
• 
Study treatment action  
• 
Outcome  
• 
Relationship with the study treatment 
• 
 Expectedness  
  

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SADEs, SAEs, and USADEs should always be recorded in the CRF and reported to the Sponsor using 
the Sponsor’s SAE reporting form. Any SAEs that occur during the screening period that resulted 
from the administration of any study procedures and are unexpected, should also be reported. The 
form should be emailed to enquiries@fwmedical.co.uk (Jill Stuart) within 24 hours of the site team 
becoming aware of the event, and the Principle Investigator should be copied in this email 
(anthony@thefunctionalgutclinic.com). If the site does not receive an acknowledgement of the 
receipt of the report within 24 hours, they should immediately contact the Principle investigator.  
  
The Sponsor should also report all serious adverse events, whether initially considered to be device 
related or not, immediately to the MHRA 
 
 
 
Concomitant medication, medical device or supplementation 
 
Restrictions regarding concomitant medicines are described below. All concomitant medicines taken 
from the time of informed consent at the Screening Visit through the End of Treatment Visit will be 
recorded on the appropriate concomitant medicine page of the participant’s CRF. 
 
28 days prior to Visit 1 
 
1) Participants must have not taken any oral or parenteral antibiotic medication at least 28 
days prior to visit 1. Participants must not commence any antibiotic therapy from signature 
of informed consent until after the end of study visit or have withdrawn participation 
2) Participants must not have used Silicolgel at least 28 days prior to visit 1.  
 
7 days prior to visit 1 
 
1) Participants must not have used laxative therapy at least 7 days prior to visit 1 and not use 
any laxative therapy for the duration of the study. 
2) Participants must not have taken a probiotic product at least 7 days prior to visit 1 and must 
refrain from using any probiotics until after the end of study visit or have withdrawn 
participation.  
 
From Day 0 to end study  
 
All medicines, medical devices and supplementation listed in this section are excluded from day 0 for 
the duration of the study.  
 
1) Any investigational drugs. 
2) All narcotics either alone or in combination (e.g., tramadol, codeine, morphine, 
propoxyphene, loperamide, diphenoxylate, and paregoric). 
3) Any medicine that is known to cause diarrhoea  
4) Any over-the-counter or prescription laxative, suppository, or enema. 
5) Any anti-spasmodic medication 
6) Any other medical advice with adsorptive properties 
7) Any medical device affecting gastrointestinal motility 
8) Antidepressants unless the participant has been on a stable dose for at least 1 month before 
visit 1 and there is no plan to change dose during the investigation.  
 
 

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Study Operations 
 
Good Clinical Practice  
 
This study will be conducted according to the protocol and in compliance with ICH GCP, the ethical 
principles stated in the Declaration of Helsinki, and other applicable regulatory requirements.  
 
The Investigator confirms the above by signing the protocol. 
 
Termination of Participants 
 
Participants will be informed that they have the right to withdraw from the study at any time for any 
reason, without prejudice to their medical care. The Investigator will make reasonable efforts to 
keep each participant in the study. However, if the Investigator removes a participant from the study 
or if the participant declines further participation, the evaluations required at the end of study visit 
should be performed if possible. All evaluations and observations, together with the description of 
the reason(s) for study withdrawal, must be recorded on the appropriate page of the participant’s 
CRF. 
 
The following are justifiable reasons for the Investigator to withdraw a participant from the study:  
• The occurrence of an AE;  
• Withdrawal of consent;  
• Unforeseen events: any event that, based on the Investigator’s judgement, makes further 
treatment inadvisable;  
• Serious violation of the study (including persistent participant attendance failure and non-
compliance).  
  
An effort must be made to determine why a participant fails to return for the necessary visits or is 
dropped from the study. Regardless of the reason for termination, all data available for the 
participant at the time of discontinuation of follow-up should be recorded where applicable on the 
CRF. All reasons for discontinuation of treatment should be documented. 
 
Financial Disclosure 
 
Relevant financial disclosures will be included in the submission to the ethical committee. 
 
Essential Documents 
 
1) Current, signed curricula vitae of the Investigator and all sub-Investigators;  
2) Copy of current medical license of the Investigator and all sub-Investigators (as 
applicable);  
3) Copy of Research Ethics Committee (REC) approved Participant information sheet;  
4) Evidence of Sponsor insurance or indemnity;  
5) Copy of the REC approval letter for the protocol and informed consent;  
6) Copy of the REC-approved informed consent document to be used;  
7) Copy of the REC approval of recruitment advertising (if applicable);  
8) A list of REC members and their qualifications, and a description of the committee’s 
working procedures. 

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During the study, the Investigator must maintain the following essential/administrative documents 
related to the study:  
1) Copy of the signed Protocol Signature Page 
2) Copy of financial disclosure form(s) for the Investigator and all sub-Investigators 
3) Curricula vitae of any new Investigator(s) and/or sub-Investigators involved in the study 
4) Adverse Event Reports  
5) Updates of laboratory/technical procedures/tests 
a. Normal value(s)/range(s) 
b. Certification 
c. Accreditation 
d. Established quality control and/or external quality assessment 
e. Other validation (where required) 
6) Responsibility Log 
7) Other logs (screening, enrolment, etc.) 
8) Signed ICFs 
9) Validated questionnaires 
10) CRFs 
 
Case Report Forms and data management  
 
All data relating to the study will be recorded in the participant’s CRF. The CRFs are to be completed 
at the time of the participant’s visit, except for results of tests performed outside the Investigator’s 
office. CRF data should indicate the participant’s participation in the study and should document the 
dates and details of study procedures, AEs, all observations, and participant status. The Investigator 
is responsible for verifying that all data entries on the CRFs are accurate and correct and ensure that 
all data are entered in a timely manner, as soon as possible after information is collected. An 
explanation should be provided for all missing data. The Investigator must provide his or her formal 
approval of all the information on the CRFs and changes to the CRFs to endorse the final submitted 
data for the participants for which he or she is responsible. 
 
The CRFs will be in the form of paper and will be stored initially in locked filing cabinets in the 
Functional Gut Clinic and subsequently archived. 
 
A record of participant screen failures will be maintained for participants who do not qualify for 
enrolment, including the reason for the failure 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Reference List 
 
1. 
Edwards SJ, Lind T, Lundell L. Systematic review of proton pump inhibitors for the acute 
treatment of reflux oesophagitis. Aliment Pharmacol Ther. 2001;15(11):1729-36. 
2. 
Edwards SJ, Lind T, Lundell L. Systematic review: proton pump inhibitors (PPIs) for the 
healing of reflux oesophagitis - a comparison of esomeprazole with other PPIs. Aliment Pharmacol 
Ther. 2006;24(5):743-50. 
3. 
Schmulson MJ, Frati-Munari AC. Bowel symptoms in patients that receive proton pump 
inhibitors. Results of a multicenter survey in Mexico. Rev Gastroenterol Mex. 2018. 
4. 
Compare D, Pica L, Rocco A, De Giorgi F, Cuomo R, Sarnelli G, et al. Effects of long-term PPI 
treatment on producing bowel symptoms and SIBO. Eur J Clin Invest. 2011;41(4):380-6. 
5. 
Fried M, Siegrist H, Frei R, Froehlich F, Duroux P, Thorens J, et al. Duodenal bacterial 
overgrowth during treatment in outpatients with omeprazole. Gut. 1994;35(1):23-6. 
6. 
Thorens J, Froehlich F, Schwizer W, Saraga E, Bille J, Gyr K, et al. Bacterial overgrowth during 
treatment with omeprazole compared with cimetidine: a prospective randomised double blind 
study. Gut. 1996;39(1):54-9. 
7. 
Williams C, McColl KE. Review article: proton pump inhibitors and bacterial overgrowth. 
Aliment Pharmacol Ther. 2006;23(1):3-10. 
8. 
Lo WK, Chan WW. Proton pump inhibitor use and the risk of small intestinal bacterial 
overgrowth: a meta-analysis. Clin Gastroenterol Hepatol. 2013;11(5):483-90. 
9. 
Sachdev AH, Pimentel M. Gastrointestinal bacterial overgrowth: pathogenesis and clinical 
significance. Ther Adv Chronic Dis. 2013;4(5):223-31. 
10. 
Dukowicz AC, Lacy BE, Levine GM. Small intestinal bacterial overgrowth: a comprehensive 
review. Gastroenterol Hepatol (N Y). 2007;3(2):112-22. 
11. 
Uehleke B, Ortiz M, Stange R. Silicea gastrointestinal gel improves gastrointestinal disorders: 
a non-controlled, pilot clinical study. Gastroenterol Res Pract. 2012;2012:750750. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Appendix 1 – Patient Information sheet for HMBT and patient preparation  
Hydrogen & Methane Breath Test - Small 
Intestinal Bacterial Overgrowth (SIBO) 
What is a Hydrogen & Methane Breath Test? 
Breath testing is used to detect abnormal growth of bacteria within the small intestine, or small 
intestinal bacterial overgrowth (SIBO). SIBO can cause a variety of symptoms including diarrhoea, 
nausea, bloating, gas and abdominal cramps.  
The breath test detects hydrogen and methane, which are gases produced by intestinal bacteria. 
Bacteria normally found in the large intestine produce these gases through fermentation of 
carbohydrates or sugars. Some of the gas produced by bacteria is absorbed by the intestine whereby 
it enters the blood and is transported to the lungs. The gases are then exhaled via the lungs through 
breathing and can be collected in a tube for analysis.  
In SIBO, the small intestinal bacteria ferment the sugars before the body has had chance to digest 
them and this produces an early rise in gas, detected in the breath.  
What are the benefits of having this test? 
This test will help your doctor understand whether SIBO is causing your symptoms and aid them in 
determining what treatment is best suited to you. 
Are there any risks associated with this test? 
There are no real risks associated with this test. You may experience some of your usual symptoms 
throughout the test, this is normal.  
What preparation is required for this test? 
For four weeks before the test— 
Do not take any antibiotics 
For one week before the test— 
Do not take any:  
 
• 
Laxatives or Stool Softeners – Movicol, Dulcolax, Senna etc 
• 
Stool Bulking Agents – Metamucil, Citrucel etc  
• 
Motility Agents – Prucalopride, Linaclotide etc  
• 
Probiotics – VSL#3, Actimel, Yakult etc 
• 
Intestinal adsorbants  
You can continue taking any other essential medicines. 

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Additionally, there must be a period of one week between any tests which require cleansing of the 
bowel e.g. colonoscopy, barium enema, before having a breath test. 
The day before the test— 
You must follow the ‘white food diet’ which consists of only the following foods and drinks: 
• 
Plain white bread 
• 
Plain white rice 
• 
White potatoes (no skin) 
• 
Baked/Grilled white meat or white fish (no oily fish) 
• 
Maximum of 2 eggs 
• 
Water 
• 
Non-flavoured black coffee (no milk) 
• 
Non-flavoured black tea (no milk and no herbal teas) 
• 
1tbsp butter/margarine/oil 
• 
Salt to flavour food   
Do not eat or drink anything else, eating prohibited foods could give false results for the test.  
For 12 hours before the test— 
Apart from water you must stop eating and drinking and fast for 12 hours before the test.  
The day of your test— 
Apart from up to 500ml/1 pint of water you should not eat or drink anything in the morning before 
your test.  
Do not smoke or chew gum on the morning of the test.   
You may take your essential medications with a small amount of water but do not take anything that 
could affect your bowel (see previous list). 
You may brush your teeth, but please try not to swallow any toothpaste.  
If you are diabetic requiring insulin or diabetes medicine, please contact us for information about 
adjusting your morning dose. 
What happens during the test? 
At your appointment the physiologist will explain how the test works, what SIBO is and ask you to 
describe your symptoms. Please feel free to ask any questions you may have about the test procedure 
at this stage. 
You will then be asked to give a baseline breath sample by blowing into a test tube through a straw. 
The test substrate, which is a non-digestible sugar, will be mixed with water and given to you to drink. 
Breath samples will then be collected every 15 minutes. During this time, you will be invited to sit in 
our waiting room which has wi-fi and television. Please do not eat, chew gum, smoke, sleep or exercise 
during your test. Throughout the test the physiologist will note any symptoms that occur. 

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The test will last 2 hours and 15 minutes. 
You may return to your usual diet and activity after the test 
Appendix 2 
HYDROGEN & METHANE BREATH TEST PROTOCOL 
 
PURPOSE 
To provide guidelines for all staff assisting with or performing this procedure. 
 
POLICY 
Hydrogen & Methane Breath Testing 
 
PROCEDURE 
 
INDICATIONS: 
1. Investigation of Small Intestinal Bacterial Overgrowth 
2. Investigation of Colonic Dysbiosis 
 
ABSOLUTE CONTRAINDICATIONS 
1. Post-prandial hypoglycaemia 
2. Failure to give consent 
 
RELATIVE CONTRAINDICATIONS 
 
1. Failure of patient to follow pre-study diet 
2. Non-adherence to cessation of smoking 
3. Failure of patient to fast for 12 hours prior to the study 
4. Antibiotic therapy in the previous 4 weeks 
 
EQUIPMENT 
 
• 
Functional Gut Diagnostics Breath Test Kit containing  
- 
10 collection tubes 
- 
10 collection tube labels 
- 
1 straw 
- 
1 
substrate 
sachet 
(lactulose/glucose/lactose/fructose) 
- 
2 bubble wrap pouches 
- 
Symptoms score sheet 
• 
Consent form and clinical history sheet 
• 
Plastic cups  
• 
Drinking water 
 
Before the procedure  
 
• 
Check the patient details including a contact telephone number 

16 – Version 2 09/05/2019 
 
• 
Obtain the patients history using the clinical history sheet. This should include: symptoms, 
duration, 
previous 
medical 
and 
surgical 
history, 
medication, 
previous 
treatments/diagnostic procedures and any known allergies 
• 
Confirm the patient has stopped required medication, followed the pre-study diet and 
fasted for the past 12 hours. 
• 
Explain the test procedure, benefits and risk of the test and obtain written consent using 
the consent form. 
 
Procedure Method 
 
• 
Collect a baseline breath sample by asking the patient to insert the straw halfway into the 
tube and breath through the straw until they see condensation. They can then remove the 
straw and replace the cap. 
• 
Ensure to fill out all the information on the collection tube label and adhere to each tube 
after sample collection. 
• 
Ask the patient if they are experiencing any symptoms (specifically bloating, nausea or 
abdominal pain) at the beginning of the test. Ask them to rate each symptom on a scale of 
0 – 10 (with 0 being no symptoms and 10 being severe symptoms) and record the results 
on the symptom score sheet. 
• 
Mix the substrate sachet with 200ml drinking water and instruct the patient to drink it. 
• 
Continue to take samples and note symptoms every 15 minutes until 10 samples have been 
collected (full test duration is 2 hours and 15 minutes). Invite the patient to sit in the waiting 
room for the rest of their test. 
• 
When collecting the 10th sample, invite the patient back into the clinic room and explain 
that results will be sent out electronically to the referring doctor in 48 hours. 
• 
Ask if they have any questions 
 
After the procedure 
 
• 
Ensure all 10 collection tubes are labelled correctly and pack them into the bubble wrap 
pouches. Put the pouches and the symptom sheet back into the kit box and post back to 
Functional Gut Diagnostics. 
• 
Dispose of the plastic cup and straw. 
 
Reporting the results 
• 
Once the Functional Gut Diagnostics technical report is uploaded to DGL, an TFGC cover 
letter will be written using the report template. This will be saved and sent as a PDF file. 
• 
Templates are available on each TFGC laptop/ computer on the desktop and have been 
emailed to each member of staff at TFGC.  
 
Clinic risk assessment 
• 
A clinical risk assessment has been made regarding this procedure which is available as a 
hard copy in the Clinic Registry folder and has been emailed to each member of staff at 
TFGC.  
 
How the results will be communicated? 
• 
If the patient consents, during the consent process, to allowing TFGC to email reports to 
the referring consultant then this will be the only option. 

17 – Version 2 09/05/2019 
 
• 
If the referrer or patient requests another method then the use of fax will be used.  
• 
TFGC is a diagnostic clinic and all reports/results will be sent to the referring consultant.  
 
 
 
Appendix 3 – Reflux Questionnaire 
Reflux Questionnaire  
 
Patient Name:                                                                                                             Date:  
GERD-HRQL Questionnaire 
 On PPIs      Off PPIs     If off, for how long? _________________ days/weeks/months 
Scale:  
0 = No symptom 
1 = Symptoms noticeable but not bothersome 
2 = Symptoms noticeable but not bothersome everyday 
3 = Symptoms bothersome everyday 
4 = Symptoms affect daily activity 
5 = Symptoms are incapacitating  
Please check the box to the right of each question to best describe your experience over the past 2 
weeks; 
1. How bad is the heartburn?                                                                                  
2. How is the heartburn when lying down?                                                          
3. How bad is the heartburn when standing up?                                                 
4. Heartburn after meals?                                                                                        
5. Does heartburn change your diet?                                                                     
6. Does heartburn wake you from sleep?                                                             
 
                                                                                                                                  Heartburn score =  
 
7. How bad is the regurgitation? 
8. Regurgitation when lying down?  
9. Regurgitation when standing up? 
10. Regurgitation after meals? 
11. Does regurgitation change your diet? 
12. Does regurgitation wake you from sleep? 
 
                                                                                                                           Regurgitation score = 
 
13. Do you have difficulty swallowing? 
□0   □1   □2   □3   □4   □5 
□0   □1   □2   □3   □4   □5 
□0   □1   □2   □3   □4   □5 
□0   □1   □2   □3   □4   □5 
□0   □1   □2   □3   □4   □5 
□0   □1   □2   □3   □4   □5 
□0   □1   □2   □3   □4   □5 
□0   □1   □2   □3   □4   □5 
□0   □1   □2   □3   □4   □5 
□0   □1   □2   □3   □4   □5 
□0   □1   □2   □3   □4   □5 
□0   □1   □2   □3   □4   □5 
□0   □1   □2   □3   □4   □5 
□0   □1   □2   □3   □4   □5 
□0   □1   □2   □3   □4   □5 

18 – Version 2 09/05/2019 
 
14. Do you have pain with swallowing? 
15. If you take medication, does this affect your daily life? 
16. How satisfied are you with your present condition?  
□ Satisfied       □ Neutral       □ Dissatisfied  
                                                                 Total score (inc. heartburn and regurgitation scores) =                                 

19 – Version 2 09/05/2019 
 
Appendix 4 – Irritable Bowel Syndrome Symptom Severity Score (IBS-SSS) 
 

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Appendix 5 – Bristol Stool Questionnaire  
 
1) Over the last 7 days, how would you describe the frequency of your bowel movements?  
                  More than 3 a day 
                  1-3 a day 
                  3-6 a week  
                  Less than 3 a week 
 
2) Using the Bristol Stool Chart above, how would you describe your average bowel movement 
over the last 7 days?  
                Type 1       Type 2       Type 3       Type 4       Type 5       Type 6       Type 7