A Prospective Exploratory Study on the Value of Bio-electrical Impedance Analysis in Irritable Bowel Syndrome
Phase: NA
Conditions: Irritable Bowel Syndrome
Sponsor: Universitair Ziekenhuis Brussel

Version 1.0     19 DEC 2021 
 
Study Protocol  
 
Study Title: 
A prospective exploratory study on the value of bio-
electrical impedance analysis in IBS. 
Study Acronym: 
BIA-IBS 
Phase of Development: 
Exploratory study 
Protocol Number: 
Protocol Version and Date: 
1.0, December 19th 2021 
EudraCT Registry Number: 
ClinicTrials.gov Registry Number:  
NCT05744258 
Indication: 
 
 
 
 
IBS 
 
 
Investigational product: 
 
 
None  
 
 
 
 
Sponsor: 
Prof. Dr. Sébastien Kindt 
Coordinating/Principal Investigator: 
Prof. Dr. Sébastien Kindt 
 
 
The information contained in this document is the property of the Sponsor/Coordinating Investiga-
tor and may not be reproduced, published or disclosed to others without written authorization of 
the Sponsor/Coordinating Investigator. 
PROTOCOL SIGNATURE PAGE 
 
Protocol Version and date: v1.0, 19 December 2021  
 
 
Protocol Title: A prospective exploratory study on the value of bio-electrical impedance analy-
sis in IBS.  
 
Sponsor: Prof. Dr. Sébastien Kindt 
 
 
 
 
 
Principal Investigator: Prof. Dr. Sébastien Kindt 
 
 
I agree: 
- 
to assume responsibility for the proper conduct of this study 
- 
to conduct the study in compliance with this protocol and any future amendments  
- 
not to implement any deviations from or changes to the protocol without prior review 
and written approval from the Ethics Committee, except where necessary to eliminate 
an immediate hazard to the subjects, or for administrative aspects of the study (where 
permitted by all applicable regulatory requirements) 
- 
that I am thoroughly familiar with the appropriate use of the investigational drug, as 
described in this protocol 
- 
to ensure that all persons assisting me with the study are adequately informed about 
the investigational drug and their study-related duties and functions as described in the 
protocol 
- 
that I am aware of and will comply with the current good clinical practice (GCP) guide-
lines and ethical principles outlined in the Declaration of Helsinki 
- 
to conduct the study in accordance with all applicable laws and regulations 
 
 
 
 
Printed name                                                      Signature                                         Date 

Version 1.0     19 DEC 2021 
 
Table of Contents 
1 Inhoud  
PROTOCOL SIGNATURE PAGE........................................................................................................... 1 
Table of Contents ............................................................................................................................ 2 
2 
Trial Registration/Protocol Summary ....................................................................................... 4 
3 
Protocol Version History .......................................................................................................... 6 
4 
Sponsor/Coordinating Investigator Information ....................................................................... 6 
5 
List of Abbreviations ................................................................................................................ 6 
6 
Introduction ............................................................................................................................. 6 
6.1 
Overview of Disease Pathogenesis ................................................................................................. 6 
6.2 
Epidemiology .................................................................................................................................... 7 
6.3 
Current Treatments .......................................................................................................................... 7 
6.4 
Study Rationale and Purpose .......................................................................................................... 7 
6.5 
Rationale for Study Design............................................................................................................... 8 
Study Schematic and Schedule of Activities ..................................................................................... 9 
6.6 
Study Schematic .............................................................................................................................. 9 
6.7 
Study Activities ............................................................................................................................... 10 
7 
Study Objectives and endpoints ............................................................................................. 10 
7.1 
Primary Objective ........................................................................................................................... 10 
7.2 
Secondary Objectives .................................................................................................................... 10 
7.3 
Endpoints ....................................................................................................................................... 10 
8 
Investigational Plan................................................................................................................ 11 
8.1 
Overall Study Design ...................................................................................................................... 11 
8.2 
Study Duration for Subjects............................................................................................................ 11 
8.2.1 
Screening ................................................................................................................................... 11 
8.2.2 
First visit ..................................................................................................................................... 11 
8.2.3 
Subsequent visits ....................................................................................................................... 11 
8.2.4 
Early Study Termination ............................................................................................................. 12 
8.2.5 
End of Study............................................................................................................................... 12 
9 
Selection of Subjects .............................................................................................................. 12 

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9.1 
Selection of Study Population ........................................................................................................ 12 
9.2 
Inclusion Criteria ............................................................................................................................. 12 
9.3 
Exclusion Criteria ........................................................................................................................... 12 
9.4 
Contraception/Pregnancy Avoidance ............................................................................................. 12 
10 
Study Assessments and Procedures ....................................................................................... 13 
10.1 
Study Assessments ........................................................................................................................ 13 
10.1.1 
Screening ............................................................................................................................... 13 
10.1.2 
First visit ................................................................................................................................. 13 
10.1.3 
Subsequent visits................................................................................................................... 13 
10.2 
Assessment Types ......................................................................................................................... 13 
10.2.1 
Clinical parameters ................................................................................................................ 13 
10.2.2 
Physical Examination ............................................................................................................ 14 
10.2.3 
IBS status .............................................................................................................................. 14 
10.2.4 
Psychological status .............................................................................................................. 14 
10.2.5 
Symptom severity .................................................................................................................. 14 
10.2.6 
Dietary and FODMAP intake ................................................................................................. 14 
10.2.7 
Physical activity ..................................................................................................................... 14 
10.2.8 
Bio-electrical Impedance Analysis ......................................................................................... 14 
11 
Data Collection and Management .......................................................................................... 15 
11.1 
Monitoring ....................................................................................................................................... 15 
11.2 
Data Collection ............................................................................................................................... 15 
11.3 
Database Management and Quality Control .................................................................................. 15 
11.4 
Statistical Considerations and Data Analysis ................................................................................. 16 
12 
Ethical Considerations ........................................................................................................... 16 
12.1 
Ethical conduct of the study ........................................................................................................... 16 
12.1.1 
Declaration of Helsinki ........................................................................................................... 16 
12.1.2 
Ethics Committee................................................................................................................... 16 
12.2 
Informed Consent ........................................................................................................................... 16 
12.3 
Patient and Study Data Protection ................................................................................................. 16 
12.4 
Subject Identification ...................................................................................................................... 16 
12.5 
Conflict of Interest .......................................................................................................................... 17 
13 
Finance and Insurance ........................................................................................................... 17 
14 
Reporting and Dissemination................................................................................................. 17 
15 
Conflict of interest statement ................................................................................................ 17 
16 
References ............................................................................................................................. 17 
 

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2 Trial Registration/Protocol Summary 
 
Information 
EudraCT number: 
Date of registration: 
 
Clinical Trial  
Authorization (CTA) 
from FAMHP (FAGG) 
Date of approval: 
 
ClinicalTrials.gov: 
 
Official Title: 
An prospective exploratory study on the value of bio-electrical imped-
ance analysis in IBS. 
Study Phase/Type: 
I 
Condition: 
IBS 
Objectives: 
The primary objective is to compare the BIA parameters including physical an-
gle (PhA) between IBS and healthy individuals. 
The secondary objectives are double: 
- 
Correlation of PhA with different parameters implicated in IBS patho-
physiology in IBS patients and healthy subjects. 
- 
Evolution of PhA according to response to therapy. 
Investigational Prod-
uct: 
None 
Interventions: 
Bio-electrical impedance analysis, questionnaires 
Endpoints: 
The primary endpoint of this study is to explore whether PhA differs 
between IBS patients and healthy volunteers at visit 1. 
 
The secondary endpoints are divided in two parts. 
The first part explores correlations at initial presentation among IBS 
patients and healthy subjects: 
- 
Correlation of PhA with IPAQ 
- 
Multiple regression of IBS status with multiple independent 
variables (PhA, IPAQ, dietary and FODMAP intake, psychologi-
cal variables, gender) 
- 
Differences in fecal microbiome between groups 
 
In the second part, we want to explore changes of PhA according to 
changes in IBS-SSS in IBS patients only. 
Study population: 
IBS patients 
Number of patients: 
20 IBS patients and 20 healthy subjects 
Overview of  
study design: 
Prospective exploratory study 
Statistical  
Considerations: 
 
Sponsor: 
Prof. Dr. Sébastien Kindt 
Country(ies) of  
Recruitment: 
Belgium 
Inclusion Criteria: 
IBS patients: 
- 
Patients aged 18 - 75 years; 
- 
Fulfilling the ROME IV criteria for IBS; 
 
For healthy volunteers: 
- 
Patients aged 18 - 75 years; 
Exclusion Criteria: 
- 
Clinical suspicion of an organic disorder different from IBS (patients 
can be included when this disorder had been excluded); 
- 
Known inflammatory bowel disorder; 
- 
Known major intestinal motility disorder; 

Version 1.0     19 DEC 2021 
 
- 
Alcohol (defined as more than 14 U per week) or other substance 
abuse; 
- 
Active psychiatric disorder; 
- 
Known systemic or auto-immune disorder with implication for the GI 
system; 
- 
Prior abdominal surgery (with the exception of cholecystectomy or ap-
pendectomy); 
- 
Any prior diagnosis of cancer other than basocellular carcinoma; 
- 
Current chemotherapy; 
- 
History of gastro-enteritis in the past 12 weeks; 
- 
Dietary supplements unless taken at a stable dose for more than 12 
weeks; 
- 
Treatment with neuromodulators (one neuromodulator taken at a sta-
ble dose for more than 12 weeks is allowed); 
- 
Pregnancy. 
Date of first  
enrolment: 
 
Target sample size: 
20 IBS patients and 20 healthy subjects 
 
 
 

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3 Protocol Version History 
 
Version No. 
Approval Date Lead EC 
Release Date 
 
 
 
 
 
 
 
 
 
 
4 Sponsor/Coordinating Investigator Information 
 
Coordinating Investigator  
Prof. Dr. Sébastien Kindt 
Sponsor 
Principal Investigator 
 
Prof. Dr. Sébastien Kindt 
Co-investigators 
 
 
 
 
 
Additional co-researchers  
 
 
 
Statistician  
 
 
 
 
Laboratory (ies) 
Pharmacy  
 
 
 
  
Study Coordinator  
 
Marijke De Wolf - Virgini Van Buggenhout 
Study sites and co-investigators 
5 List of Abbreviations 
4dFD  
 
Four Day Food Diary 
BIA 
 
 
Bio-electrical Impedance Analysis 
FODMAP 
 
Fructo, oligo-, di-, polysacchardies and polyols 
HRV  
 
Heart Rate Variability 
IBS 
 
 
Irritable Bowel Syndrome 
IBS-SSS 
 
IBS-Symptom Severity Scale 
IPAQ  
 
Internation Physical Activity Questionnaire 
6 Introduction 
6.1 
Overview of Disease Pathogenesis 
In many aspects, irritable bowel syndrome (IBS) remains a mystery. According to the Rome IV 
consensus, it is defined as abdominal pain for 3 days a week present since at least 3 months with 
onset at least 6 months earlier (Lacy 2016). The abdominal pain needs to be associated with two of 
the following: change in stool form, change in stool frequency or associated with defecation. The 
aetiology as well as the pathophysiology are uncertain. Studies attribute a role to prior infection, 
low-grade inflammation, genetic susceptibility, psychological influences and disturbances of the 
brain-gut axis. As a result of the unclear pathophysiology, a multitude of therapeutic interventions 
are available, varying from promotion of a healthy lifestyle, dietary modifications, treatments tar-
geting the gut microbiome, antispasmodics, prokinetic or anti-kinetic treatments as well as psycho-
logical interventions.  
 

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All guidelines recommend lifestyle modifications with increased physical activity, when treating 
IBS. While the beneficial effects of increased physical exercise have been demonstrated (Johannes-
son 2011), research on the underlying mechanisms underlying this positive effect remain scarce. Di-
etary modifications, changes in the gut microbiome (Claus 2021), improved intestinal barrier func-
tion (Dalton 2019, Pasini 2019), decreased stress response (Caplin 2021), increased vagal tone 
(Bonaz 2016), improved mental well-being (Hale 2021, Grocke-Dewey 2021) have been proposed. 
Further complicating this equation, endurance athletes also report IBS-like symptoms (Killian 
2019). However, it remains unknown whether the same pathophysiology is involved as compared to 
IBS patients with a sedentary lifestyle. Increased intestinal permeability has been implicated. 
 
Apart from the uncertainties about the pathophysiological mechanisms, the absence of an objective 
marker to diagnose or to follow-up the evolution of IBS represents a major drawback in IBS re-
search. Diagnosis of IBS largely relies on the clinical symptoms and absence of alarm features. No 
diagnostic test confirms or refutes the diagnosis. Moreover, response to therapy is measured as the 
improvement of symptoms, which is again susceptible to subjective interpretation by the subject. 
Current research focuses on different candidate markers (Nakov 2021) such as volatile organic 
compounds, faecal or serum biomarkers. 
Phase Angle (PhA) is a new marker for body cell mass and frailty, derived from Bioelectrical Im-
pedance Analysis (BIA). It has been shown to provide insight into the muscle mass in health and 
disease at different age (Marini 2012, Rodriguez-Rodriguez 2016, Zanforlini 2019). PhA is consid-
ered a potential marker of oxidative and inflammatory processes (da Silva 2022). More recently, its 
role as a screening tool for physical fitness in obese adults was demonstrated (Streb 2020). Consid-
ering the putative role of physical inactivity, dietary factors such as Fructo-, oligo-, di-, polysaccha-
rides and polyols (FODMAP) and low grade inflammation in IBS symptoms as well as physical fit-
ness, PhA might act as a marker for the disease and/ or its evolution during treatment. 
 
6.2 
Epidemiology 
Up to 5% of the worldwide population suffers from IBS when diagnosed based on the Rome IV cri-
teria. This number increases even more when applying the Rome III criteria, as this diagnosis 
doesn’t restrict the cardinal symptom to abdominal pain, but also allows for abdominal discomfort. 
On the other hand, a sedentary lifestyle is frequently observed in Western countries. Physical inac-
tivity has been associated with major conditions including obesity, atherosclerosis, non-alcoholic 
fatty liver disease and diabetes, and might as well be implicated in the pathophysiology of IBS. 
 
6.3 
Current Treatments 
Current treatment of IBS can be broadly divided into lifestyle modifications, dietary interventions, 
medical treatment and non-pharmaceutical psychological interventions, including cognitive behav-
ioral therapy. Despite the fact that lifestyle modifications are included in virtually all guidelines, re-
search in the role of physical activity remains underassessed as compared to the other interventions. 
 
6.4 
Study Rationale and Purpose 
The study aim is to investigate the BIA parameters in general, and PhA in particular in IBS patients 
and to compare these with values from healthy controls, while assessing the relationship with other 
confounding parameters in IBS: psychological parameters, physical activity, dietary pattern (with 

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special interest in FODMAP intake). In a second phase, the evolution of the BIA parameters will be 
analyzed according to response to therapy. 
6.5 
Rationale for Study Design 
The role and significance of bio-electrical impedance analysis has not been studied in IBS. There-
fore, we designed this exploratory study to assess its potential role in the diagnosis and follow-up of 
treatment in IBS. 
 
 
 
 
 

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Study Schematic and Schedule of Activities 
6.6 
Study Schematic 
 
 
 
Visit 1 
Screening 
Visit X 
Inclusion/exclusion 
ROME IV 
BIA 
IBS-SSS 
Clinical parameters 
Psychological questionnaires 
IPAQ 
4dFD 
 
Intervention  
4dFD     Four-day Food Diary 
BIA        Bio-electrical Impedance Analysis 
IBS-SSS  IBS-Symptom Severity Scale 
BIA 
IBS-SSS 
Clinical parameters 
IPAQ 
4dFD 
 

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6.7 
Study Activities 
 
Screening 
Visit 1 
Subsequent visits (for 
patients) 
Inclusion/exclusion 
X 
 
 
Informed consent 
X 
 
 
Rome IV 
X 
 
 
Clinical parameters 
 
X 
X 
Intervention type 
 
X 
X 
Psychological ques-
tionnaires 
 
X 
 
IPAQ 
 
X 
X 
Four Day Food Diary 
 
X 
X 
BIA 
 
X 
X 
IBS-SSS 
 
X 
X 
 
7 Study Objectives and endpoints 
7.1 
Primary Objective 
The primary objective is to compare the BIA parameters including PhA between IBS and healthy 
individuals. 
7.2 
Secondary Objectives 
The secondary objectives are double: 
- 
Correlation of PhA with different parameters implicated in IBS pathophysiology in IBS pa-
tients and healthy subjects. 
- 
Evolution of PhA according to response to therapy. 
 
7.3 
Endpoints 
The primary endpoint of this study is to explore whether PhA differs between IBS patients and 
healthy volunteers at visit 1. 
 
The secondary endpoints are multiple and are divided in two parts. 
The first part explores correlations at initial presentation among IBS patients and healthy subjects: 
- 
Correlation of PhA with IPAQ 
- 
Multiple regression of IBS status with multiple independent variables (PhA, IPAQ, dietary 
and FODMAP intake, psychological variables, gender) 
 
In the second part, we want to explore changes of PhA according to changes in IBS-SSS in IBS pa-
tients only. 

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8 Investigational Plan 
8.1 
Overall Study Design 
Explorative non-interventional prospective study. The choice of therapeutic intervention are deter-
mined at the discretion of the gastro-enterologist according to standard clinical practice. Several in-
terventions are scheduled in addition to standard clinical practice. 
 
8.2 
Study Duration for Subjects 
8.2.1 
Screening 
Screening will last about 15 minutes to check the subject’s eligibility either as IBS patient or 
healthy subject. Informed consent will be obtained. 
Eligible subjects will receive instruction on how to fill in the 4dFD. The 4dFD should be filled in 
during the week following the first visit. 
 
8.2.2 
First visit 
Participants will be instructed to refrain from eating, drinking and smoking for 6h before attending 
the first visit. Clinical parameters will be recorded.  
 
During first visit, participants will fill in several questionnaires: 
- 
IBS-SSS 
- 
Psychological parameters: 
o GAD-7 
o PHQ-9 
o PHQ-15 
o VSI 
- 
IPAQ 
 
BIA will be performed. 
The first visit will last 30 minutes. 
8.2.3 
Subsequent visits 
Only IBS patients will attend subsequent visits. 
The 4dFD should be filled in during the week preceeding the visit. 
As much as possible, visits will take place on the same day as the visit to the outpatient clinic. Pa-
tients will be instructed to refrain from eating, drinking and smoking for 6h before attending the 
visit.  During these visits the prescribed intervention will be recorded. 
During the subsequent visits, IBS patients will fill in several questionnaires: 
- 
IBS-SSS 
- 
IPAQ 
 
BIA will be performed. 
Each subsequent visit will last 30 minutes. 

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8.2.4 
Early Study Termination 
No early study termination visit is required in this explorative non-interventional study. 
8.2.5 
End of Study 
The study ends when the last study participant quits the study. 
9 Selection of Subjects 
9.1 
Selection of Study Population 
IBS patients will be recruited from the outpatient clinic at the Department of Gastroenterology and 
Hepatology of UZ Brussels. IBS is defined according to ROME IV criteria. 
Healthy subjects will be recruited by advertisement. 
9.2 
Inclusion Criteria  
IBS patients: 
- 
Patients aged 18 - 75 years; 
- 
Fulfilling the ROME IV criteria for IBS; 
 
For healthy volunteers: 
- 
Patients aged 18 - 75 years; 
 
9.3 
Exclusion Criteria 
- 
Clinical suspicion of an organic disorder different from IBS (patients can be included when 
this disorder had been excluded); 
- 
Known inflammatory bowel disorder; 
- 
Known major intestinal motility disorder; 
- 
Alcohol (defined as more than 14 U per week) or other substance abuse; 
- 
Active psychiatric disorder; 
- 
Known systemic or auto-immune disorder with implication for the GI system; 
- 
Prior abdominal surgery (with the exception of cholecystectomy or appendectomy); 
- 
Any prior diagnosis of cancer other than basocellular carcinoma; 
- 
Current chemotherapy; 
- 
History of gastro-enteritis in the past 12 weeks; 
- 
Dietary supplements unless taken at a stable dose for more than 12 weeks; 
- 
Treatment with neuromodulators (one neuromodulator taken at a stable dose for more than 
12 weeks is allowed); 
- 
Pregnancy. 
 
9.4 
Contraception/Pregnancy Avoidance 
As no intervention is planned, there is no specific requirement for contraception. However, no fur-
ther data will be collected from pregnant subjects. 
 

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10 Study Assessments and Procedures 
10.1 
Study Assessments 
10.1.1 
Screening 
At screening a subject’s eligibility will be reviewed. Patients should fulfill the ROME IV criteria 
for IBS. This also includes a physical examination to rule out indications of a possible organic 
cause for the abdominal symptoms. If another cause of the symptoms is suspected based on history 
or clinical examination, it should be ruled out before inclusion. 
Informed consent will be obtained during the screening visit prior to scheduling study assessments. 
Instructions about how to fill in the 4DFD will be provided. 
10.1.2 
First visit 
Study participants should be fasting for 6h when attending the first visit. 
 
The 4dFD should be filled in during the week preceding the visit. 
Clinical parameters of both IBS patients and healthy subjects will be recorded during the first visit. 
 
During first visit, participants will fill in several questionnaires: 
- 
IBS-SSS 
- 
Psychological parameters: 
o GAD-7 
o PHQ-9 
o PHQ-15 
o VSI 
- 
IPAQ 
 
BIA will be performed. 
 
10.1.3 
Subsequent visits 
Only IBS patients will attend subsequent visits. They should be fasting for 6h. 
The 4dFD should be filled in during the week preceding the visit. 
Clinical parameters of IBS patients will be recorded. 
 
During subsequent visits, participants will fill in 2 questionnaires: 
- 
IBS-SSS 
- 
IPAQ 
 
BIA will be performed. 
 
10.2 
Assessment Types  
10.2.1 
Clinical parameters 
Body length (cm) will be recorded during the first visit. 

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Body weight (kg), waist circumference (cm), systolic and diastolic blood pressure (mmHg), heart 
rate (bpm) will be recorded during each visit. Body mass index will be calculated. 
10.2.2 
Physical Examination  
A physical examination will be performed during each visit in order to exclude a possible organic 
cause of the abdominal symptoms. 
 
10.2.3 
IBS status 
Presence of IBS will be established based on the ROME IV criteria (appendix 6). IBS will be sub-
typed according to the predominant stool pattern. 
 
10.2.4 
Psychological status 
Presence of anxiety, depression and somatization will be evaluated by resp. the PHQ-9, the GAD-7 
(Spitzer 2006) and PHQ-15 (Kroenke 2002) (appendices 2-4). Gut-directed anxiety will be assessed 
by the VSI (Labus 2004) (appendix 1). Evaluation of psychological status will be performed during 
the first visit. 
 
10.2.5 
Symptom severity 
Symptom severity will be assessed by the IBS-SSS (Francis 1997) during each visit (appendix 7). 
 
10.2.6 
Dietary and FODMAP intake 
Dietary and FODMAP intake will be evaluated by the 4dFD (appendix 8) at each visit. 
 
10.2.7 
Physical activity 
Physical activity will be assessed by the International Physical Activity Questionnaire (IPAQ) (Ap-
pendix 5). 
 
10.2.8 
Bio-electrical Impedance Analysis 
Bio-electrical Impedance Analysis will be performed by trained personnel. BIA will be performed 
after fasting for at least 6 hours. Subjects should refrain from intensive physical activity the day be-
fore the measurement. For women, measurements will be performed outside menstruating periods. 
Subjects will lay down on an examination couch with bare feet. Any jewelry will be removed. 
Reactance and resistance will be obtained. Phase angle will be calculated according to the formula: 
 
PhA (°) = (reactance/ resistance° x (180°/π). 
 
Body composition, including muscle mass and percentage body fat will be calculated. 

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11 Data Collection and Management 
11.1 
Monitoring  
The study may be inspected by regulatory authorities, including internal audits from the study cen-
ter of UZ Brussels. The investigators agree by written consent with this protocol to fully co-operate 
and support audits and inspections compliance checks by allowing individuals to have access to all 
the study documentation. 
11.2 
Data Collection 
The investigator will ensure careful entry in the CRF of the clinical data required by the study pro-
tocol, checking for concordance with the source documents. The CRF will be filled out in English. 
Correction to the CRF must be carried out by the investigator or a designated member of the staff. 
All questions in the CRF should be answered in full. The investigator must provide a reasonable ex-
planation of all missing data. 
The CRF will be completed and signed by the investigator. 
 
11.3 
Database Management and Quality Control  
The investigator should ensure the accuracy, completeness, legibility, and timeliness of the data re-
ported to the sponsor in the eCRF and in all required reports. 
The investigator must keep source documents for each subject in the study. All information on the 
eCRF must be traceable to these source documents, which are generally stored in the subject's med-
ical file. The source documents should contain all demographic and medical information, including 
laboratory data, ECGs, etc., and the original signed informed consent forms. 
Data reported on the eCRF that derive from source documents should be consistent with the source 
documents or the discrepancies should be explained. 
The investigator and the sponsor should maintain the study documents as specified in the “Essential 
Documents for the Conduct of a Clinical Trial” chapter 8 of ICH-GCP and as required by the appli-
cable regulatory requirement(s). 
These are documents which individually and collectively permit evaluation of a study and the qual-
ity of the data produced and include groups of documents, generated before the study commences, 
during the clinical study, and after termination of the study and include but are not limited to: study 
protocol, amendments, submission and approval of EC, raw data of subjects including lab tests, in-
surance contracts, signed informed consent forms, confidential subjects identification code, eCRF, 
curricula vitae of the investigator and other participants in the study, study staff lists and responsi-
bilities, monitoring reports and final study report. 
The investigator and the sponsor should take measures to prevent accidental or premature destruc-
tion of these documents. 
The investigator and the sponsor must retain study documents as long as needed to comply with 
ICH-GCP, national and international regulations. By signing the protocol, the investigator and the 
sponsor agree to adhere to these requirements. 
 

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11.4 
Statistical Considerations and Data Analysis 
In this explorative study assessing the applicability of BIA as a diagnostic modality or tool for ob-
jective evaluation of treatment response, 20 IBS subjects and 20 healthy volunteers will be re-
cruited. Based on the results, a larger study will be considered. 
Data collection and analysis will be performed by the study team. 
 
12 Ethical Considerations 
12.1 
Ethical conduct of the study 
12.1.1 
Declaration of Helsinki 
This study will be performed in accordance with the Declaration of Helsinki, International Confer-
ence on Harmonisation (ICH) Good Clinical Practice (GCP) guidelines and local laws and regula-
tion as recommended by the European Community. 
 
12.1.2 
Ethics Committee 
Approval will be obtained from the appropriate regulatory authority in Belgium prior to the start of 
the study, in this case the Ethical Committee of UZ Brussel. Investigators and personnel are respon-
sible for acting in accordance with their local regulatory requirements. 
The study will start on-site only after approval by the local ethical committee. 
 
12.2 
Informed Consent 
All eligible patients should provide a signed and dated informed consent before inclusion into this 
study. 
 
12.3 
Patient and Study Data Protection  
The eCRF will serve as the principal source of data. Source documentation serves to substantiate 
the integrity of the study data, confirms observations that are recorded and confirms the existence of 
the study participants. 
These data will be checked with adequate precautions to ensure to confidentiality and compliance 
with applicable data privacy protection laws and regulations. Personnel with responsibilities requir-
ing access to these personal data agree to keep the data confidential. 
 
12.4 
Subject Identification  
The site will affirm and uphold the principle of the patient’s right to protection against the invasion 
of privacy.  Throughout this study and any subsequent data analyses, all data will be identified only 
by protocol number and ID number. 
Only the treating physician will keep the ICF and identity of the patient and healthy subject.  
 

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The Data Protection Officer (DPO) will be informed about the database required to perform this 
study. This included information concerning the goal, the expected number of patients, the type of 
data that are recorded and the person responsible for the database, according to Belgian regulation. 
 
12.5 
Conflict of Interest 
All participating investigators will provide written information on possible conflicts of interest upon 
initiation of the study at their center.  
 
13 Finance and Insurance 
Adequate insurance coverage for (i) medical professional and/or malpractice liability and (ii) gen-
eral liability will be maintained in full force and effect during the term of this study, and following 
termination of the study to cover any claims arising from the trial. 
Additionally in accordance to art. 29 of Belgian Law relating to experiments on human persons, 
dated May 7th, 2004 an insurance contract will be obtained in order to cover Trial Participants. 
 
14 Reporting and Dissemination 
Reporting and dissemination requires prior agreement of the principle investigator. 
 
15 Conflict of interest statement 
All participating investigators will provide a list of possible conflicts of interest at the start of the 
study. This list will be checked every 12 months, and updated if necessary. 
 
16 References 
Bonaz B, Sinniger V, Pellissier S. Vagal tone: effects on sensitivity, motility, and inflammation. 
Neurogastroenterol Motil. 2016 Apr;28(4):455-62. doi: 10.1111/nmo.12817. PMID: 27010234. 
 
Caplin A, Chen FS, Beauchamp MR, Puterman E. The effects of exercise intensity on the cortisol 
response to a subsequent acute psychosocial stressor. Psychoneuroendocrinology. 2021 
Sep;131:105336. doi: 10.1016/j.psyneuen.2021.105336. Epub 2021 Jun 18. 
Clauss M, Gérard P, Mosca A, Leclerc M. Interplay Between Exercise and Gut Microbiome in the 
Context of Human Health and Performance. Front Nutr. 2021 Jun 10;8:637010. doi: 
10.3389/fnut.2021.637010. PMID: 34179053; PMCID: PMC8222532. 
 
Craig CL, Marshall AL, Sjöström M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, 
Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and 

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10.1249/01.MSS.0000078924.61453.FB. PMID: 12900694. 
 
da Silva BR, Gonzalez MC, Cereda E, Prado CM. Exploring the potential role of phase angle as a 
marker of oxidative stress: A narrative review. Nutrition. 2022 Jan;93:111493. doi: 
10.1016/j.nut.2021.111493. Epub 2021 Sep 20. PMID: 34655952. 
 
Dalton A, Mermier C, Zuhl M. Exercise influence on the microbiome-gut-brain axis. Gut Microbes. 
2019;10(5):555-568. doi: 10.1080/19490976.2018.1562268. Epub 2019 Jan 31. PMID: 30704343; 
PMCID: PMC6748614. 
Francis CY, Morris J, Whorwell PJ. The irritable bowel severity scoring system: a simple method 
of monitoring irritable bowel syndrome and its progress. Aliment Pharmacol Ther. 1997 
Apr;11(2):395-402.  
 
Grocke-Dewey M, Hardison-Moody A, Haynes-Maslow L, Maras S, Webber E, Andress L, Hough-
taling B, Patton-Lopez M, Shanks J, Byker-Shanks C. Examining the relationship between physical 
activity and mental health during the COVID-19 pandemic across five U.S. States. Prev Med Rep. 
2021 Dec;24:101537. doi: 10.1016/j.pmedr.2021.101537. Epub 2021 Aug 26. PMID: 34580623; 
PMCID: PMC8459674. 
 
Hale GE, Colquhoun L, Lancastle D, Lewis N, Tyson PJ. Review: Physical activity interventions 
for the mental health and well-being of adolescents - a systematic review. Child Adolesc Ment 
Health. 2021 Nov;26(4):357-368. doi: 10.1111/camh.12485. Epub 2021 Jun 9. PMID: 34105239. 
 
Johannesson E, Simrén M, Strid H, Bajor A, Sadik R. Physical activity improves symptoms in irri-
table bowel syndrome: a randomized controlled trial. Am J Gastroenterol. 2011 May;106(5):915-
22. doi: 10.1038/ajg.2010.480. Epub 2011 Jan 4. PMID: 21206488. 
 
Killian LA, Lee SY. Irritable bowel syndrome is underdiagnosed and ineffectively managed among 
endurance athletes. Appl Physiol Nutr Metab. 2019 Dec;44(12):1329-1338. doi: 10.1139/apnm-
2019-0261. Epub 2019 May 7. PMID: 31063696. 
 
Labus JS, Bolus R, Chang L, Wiklund I, Naesdal J, Mayer EA, Naliboff BD. The Visceral Sensitiv-
ity Index: development and validation of a gastrointestinal symptom-specific anxiety scale. Aliment 
Pharmacol Ther. 2004 Jul 1;20(1):89-97. 
 
Lacy BE, Mearin F, Chang L, Chey WD, Lembo AJ, Simren M, Spiller R. Bowel Disorders. Gas-
troenterology. 2016 Feb 18:S0016-5085(16)00222-5. doi: 10.1053/j.gastro.2016.02.031. Epub 
ahead of print. PMID: 27144627. 
 
Marini E, Buffa R, Saragat B, Coin A, Toffanello ED, Berton L, Manzato E, Sergi G. The potential 
of classic and specific bioelectrical impedance vector analysis for the assessment of sarcopenia and 
sarcopenic obesity. Clin Interv Aging. 2012;7:585-91. doi: 10.2147/CIA.S38488. Epub 2012 Dec 
18. PMID: 23269864; PMCID: PMC3529635. 
 
Nakov R, Snegarova V, Dimitrova-Yurukova D, Velikova T. Biomarkers in Irritable Bowel Syn-
drome: biological rationale and diagnostic value. Dig Dis. 2021 Mar 22. doi: 10.1159/000516027. 
Epub ahead of print. PMID: 33752201. 
 

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Pasini E, Corsetti G, Assanelli D, Testa C, Romano C, Dioguardi FS, Aquilani R. Effects of chronic 
exercise on gut microbiota and intestinal barrier in human with type 2 diabetes. Minerva Med. 2019 
Feb;110(1):3-11. doi: 10.23736/S0026-4806.18.05589-1. PMID: 30667205. 
 
Rodríguez-Rodríguez F, Cristi-Montero C, González-Ruíz K, Correa-Bautista JE, Ramírez-Vélez 
R. Bioelectrical Impedance Vector Analysis and Muscular Fitness in Healthy Men. Nutrients. 2016 
Jul 2;8(7):407. doi: 10.3390/nu8070407. PMID: 27384579; PMCID: PMC4963883. 
 
Spitzer RL, Kroenke K, Williams JB, Löwe B. A brief measure for assessing generalized anxiety 
disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. 
 
Streb AR, Hansen F, Gabiatti MP, Tozetto WR, Del Duca GF. Phase angle associated with different 
indicators of health-related physical fitness in adults with obesity. Physiol Behav. 2020 Oct 
15;225:113104. doi: 10.1016/j.physbeh.2020.113104. Epub 2020 Jul 23. PMID: 32712208. 
 
Zanforlini BM, Trevisan C, Bertocco A, Piovesan F, Dianin M, Mazzochin M, Alessi A, Zoccarato 
F, Manzato E, Sergi G. Phase angle and metabolic equivalents as predictors of frailty transitions in 
advanced age. Exp Gerontol. 2019 Jul 15;122:47-52. doi: 10.1016/j.exger.2019.04.016. Epub 2019 
Apr 24. PMID: 31028839. 
 
 

Version 1.0     19 DEC 2021 
 
APPENDIX 1: Visceral Sensitivity Index (VSI) (Labus 2004) 
 
Below are statements that describe how some people respond to symptoms or discomfort 
in their belly or lower abdomen. These may include pain, diarhoea, constipation, bloating 
or sense of urgency. Please answer 'how strongly you agree or disagree' with each of 
these statements, AS THEY RELATE TO YOU. Answer all of the statements as honestly and 
thoughtfully as you can. 
 
 
Strongly 
agree 
Moder-
ately 
agree 
Mildly 
agree 
Mildly 
disa-
gree 
Moder-
ately 
agree 
Strong-
ly disa-
gree 
1. I worry that whenever I eat 
during the day, bloating and 
distension in my belly will get 
worse. 
 
1 
2 
3 
4 
5 
6 
2. I get anxious when I go to a 
new restaurant. 
 
1 
2 
3 
4 
5 
6 
3. I often worry about problems 
in my belly. 
 
1 
2 
3 
4 
5 
6 
4. I have a difficult time enjoying 
myself because I cannot get 
my mind off of discomfort in 
my belly. 
 
1 
2 
3 
4 
5 
6 
5. I often fear that I won't be able 
to have a normal bowel move-
ment. 
 
1 
2 
3 
4 
5 
6 
6. Because of fear of developing 
abdominal discomfort, I sel-
dom try new foods. 
 
1 
2 
3 
4 
5 
6 
7. No matter what I eat, I will 
probably feel uncomfortable. 
 
1 
2 
3 
4 
5 
6 
8. As soon as I feel abdominal 
discomfort I begin to worry 
and feel anxious. 
 
1 
2 
3 
4 
5 
6 
9. When I enter a place I haven't 
been before, one of the first 
things I do is look for a bath-
room. 
 
1 
2 
3 
4 
5 
6 
10. I am constantly aware of the 
feelings I have in my belly. 
 
1 
2 
3 
4 
5 
6 
11. I often feel discomfort in my 
belly could be a sign of a seri-
ous illness. 
 
1 
2 
3 
4 
5 
6 

Version 1.0     19 DEC 2021 
 
12. As soon as I awake, I worry 
that I will have discomfort in 
my bely during the day. 
 
1 
2 
3 
4 
5 
6 
13. When I feel discomfort in my 
belly, it frightens me. 
 
1 
2 
3 
4 
5 
6 
14. In stressful situations, my belly 
bothers me a lot. 
 
1 
2 
3 
4 
5 
6 
15. I constantly think about what 
is happening in my belly. 
 
1 
2 
3 
4 
5 
6 
 
 
 

Version 1.0     19 DEC 2021 
 
Appendix 2: General Anxiety Disorder 7 (GAD-7) (Spitzer 2006) 
 
Over the last 2 weeks, how often have you been both-
ered by the following problems? 
Not at 
all 
Several 
days 
Over 
half the 
days 
Nearly 
every 
day 
1. Feeling nervous, anxious, or on edge 
 
0 
1 
2 
3 
2. Not being able to stop or control worrying 
 
0 
1 
2 
3 
3. Worrying too much about different things 
 
0 
1 
2 
3 
4. Trouble relaxing 
 
0 
1 
2 
3 
5. Being so restless that it's hard to sit still 
 
0 
1 
2 
3 
6. Becoming easily annoyed or irritable 
 
0 
1 
2 
3 
7. Feeling afraid as if something awful might happen 
 
0 
1 
2 
3 
 
If you checked off any problems, how difficult have these made it for you to do your 
work, take care of things at home, or get along with other people? 
 
Not difficult at all 
☐        
Somewhat difficult ☐ 
Very difficult  
☐ 
Extremely difficult ☐ 
 
 

Version 1.0     19 DEC 2021 
 
Appendix 3: Patient Health Questionnaire-9 (PHQ-9) (Kroenke 2001) 
 
Over the last 2 weeks, how often have you been both-
ered by any of the following problems? 
Not at 
all 
Several 
days 
More 
than 
half the 
days 
Nearly 
every 
day 
1. Little interest or pleasure in doing things 
 
0 
1 
2 
3 
2. Feeling down, depressed, or hopeless 
 
0 
1 
2 
3 
3. Trouble falling or staying asleep, or sleeping too 
much 
 
0 
1 
2 
3 
4. Feeling tired or having little energy 
 
0 
1 
2 
3 
5. Poor appetite or overeating 
 
0 
1 
2 
3 
6. Feeling bad about yourself - or that you are a failure 
or have let yourself or your family down 
 
0 
1 
2 
3 
7. Trouble concentrating on things, such as reading 
the newspaper or watching television 
 
0 
1 
2 
3 
8. Moving or speaking so slowly that other people 
could have noticed? Or the opposite - being so fidg-
ety or restless that you have been moving around a 
lot more than usual 
0 
1 
2 
3 
9. Thoughts that you would be better off dead or hurt-
ing yourself in some way 
0 
1 
2 
3 
 
If you checked off any problems, how difficult have these problems made it for you to do 
your work, take care of things at home, or get along with other people? 
 
Not difficult at all 
☐        
Somewhat difficult ☐ 
Very difficult  
☐ 
Extremely difficult ☐ 
 
 

Version 1.0     19 DEC 2021 
 
APPENDIX 4: Patient Health Questionnaire-15 (PHQ-15) (Kroenke 2002) 
 
During the past 4 weeks, how much have you been 
bothered by any of the following problems? 
 
Not both-
ered at all 
Bothered a 
little 
Bothered a 
lot 
1. Stomach pain 
 
0 
1 
2 
2. Back pain 
 
0 
1 
2 
3. Pain in your arms, legs, or joints (knees, hips, etc.) 
 
0 
1 
2 
4. Menstrual cramps or other problems with your peri-
ods (women only) 
 
0 
1 
2 
5. Headaches 
 
0 
1 
2 
6. Chest pain 
 
0 
1 
2 
7. Dizziness 
 
0 
1 
2 
8. Fainting spells 
 
0 
1 
2 
9. Feeling your heart pound or race 
 
0 
1 
2 
10. Shortness of breath 
 
0 
1 
2 
11. Pain or problems during sexual intercourse 
 
0 
1 
2 
12. Constipation, loose bowels, or diarrhea 
 
0 
1 
2 
13. Nausea, gas, or indigestion 
 
0 
1 
2 
14. Feeling tired or having low energy 
 
0 
1 
2 
15. Trouble sleeping 
 
0 
1 
2 
 
 
 

Version 1.0     19 DEC 2021 
 
Appendix 5: International Physical Activity Questionnaires – Long Form 
 
Part 1 Job-related physical activity 
 
The first section is about your work. This includes paid jobs, farming, volunteer work, 
course work, and any other unpaid work that you did outside your home. Do not include 
unpaid work you might do around your home, like housework, yard work, general mainte-
nance, and caring for your family. They are asked in Part 3. 
 
1. Do you currently have a job or do any unpaid work outside your home? 
☐ Yes 
☐ No → Skip to part 2: transportation 
 
2. During the last 7 days, on how many days did you do vigorous physical activities 
like heavy lifting, digging, heavy construction, or climbing stairs as part of your 
work? Think about only those physical activities that you did for at least 10 
minutes at a time. 
                 days per week 
☐ No vigorous job-related physical activity → skip to question 4 
 
3. How much time did you usually spend on one of those days doing vigorous physi-
cal activities as part of your work? 
                 hours per day 
                 minutes per day 
 
 
4. Again, think about only those physical activities that you did for at least 10 
minutes at a time. During the last 7 days, on how many days did you do moder-
ate physical activities like carrying loads as part of your work? Please do not in-
clude walking. 
                 days per week 
☐ No moderate job-related physical activity → skip to question 6 
 
5. How much time did you usually spend on one of those days doing moderate physi-
cal activities as part of your work? 
                 hours per day 
                 minutes per day 
 
6. During the last 7 days, on how many days did you walk for at least 10 minutes at 
a time as part of your work? Please do not count any walking you did to travel to 
or from work. 
                 days per week 
☐ No moderate job-related physical activity → skip to part 2: transportation 
 
7. How much time did you usually spend on one of those days walking as part of 
your work? 
                 hours per day 
                 minutes per day 
 
 
Part 2: transportation physical activity 

Version 1.0     19 DEC 2021 
 
 
These questions are about how you traveled from place to place, including to places like 
work, stores, movies and so on. 
 
8. During the last 7 days, on how manydays did you travel in a motor vehicle like a 
train, bus, car, or tram? 
                 days per week 
☐ No traveling in a motor vehicle → skip to question 10 
 
9. How much time did you usually spend on one of those days traveling in a train, 
bus, car, tram, or other kind of motor vehicle? 
                 hours per day 
                 minutes per day 
 
Now think only about the bicycling and walking you might have done to travel to and 
from work, to do errands, or to go from place to place. 
 
10. During the last 7 days, on how many days did you do bicycle for at least 10 
minutes at a time to go from place to place? 
                 days per week 
☐ No bicycling from place to place → skip to question 12 
 
11. How much time do you usually spend on one of those days to bicycle from place 
to place? 
                 hours per day 
                 minutes per day 
 
12. During the last 7 days, on how many days did you walk for at least 10 minutes at 
a time to go from place to place? 
                 days per week 
☐ No walking from place to place → skip to part 3: housework, house maintaining,  
and caring for family 
 
13. How much time did you usually spend on one of those days walking from place to 
place? 
                 hours per day 
                 minutes per day 
 
 
Part 3: Housework, house maintaining, and caring for family 
 
This section is about some of the physical activities you might have done in the last 7 
days in and around your home, like housework, gardening, yard work, general mainte-
nance work, and caring for your family. 
 
14. Think about only those physical activities that you did for at least 10 minutes at a 
time. During the last 7 days, on how many days did you do vigorous physical ac-
tivities like heavy lifting, chopping wood, shoveling snow, or digging in the gar-
den or yard? 
                 days per week 
☐ No vigorous activity in garden or yard → skip to question 16 

Version 1.0     19 DEC 2021 
 
15. How much time did you usually spend on one of those days doing vigorous physi-
cal activities in the garden or yard? 
                 hours per day 
                 minutes per day 
 
16. Again, think about only those physical activities that you did for at least 10 
minutes at a time. During the last 7 days, on how many days did you do moder-
ate activities like carrying light loads, sweeping, washing windows, and raking in 
the garden or yard? 
                 days per week 
☐ No moderate activity in garden or yard → skip to question 18 
 
17. How much time did you usually spend on one of those days doing moderate 
physical activities in the garden or yard? 
                 hours per day 
                 minutes per day 
 
18. Once again, think about only those physical activities that you did for at least 10 
minutes at a time. During the last  days, on how many days did you do moderate 
activities like carrying light loads, washing windows, scrubbing floors and sweep-
ing inside your home? 
                 days per week 
☐ No moderate activity inside home → skip to part 4: recreation, sport and leisure- 
time physical activity 
 
19. How much time did you usually spend on one of those days doing moderate 
physical activities inside your home? 
                 hours per day 
                 minutes per day 
 
 
Part 4: Recreation, sport, and leisure-time physical activity 
 
This section is about all the physical activities that you did in the last 7 days solely for 
recreation, sport, exercise or leisure. Please do not include any activities you have already 
mentioned. 
 
20. Not counting any walking you have already mentioned, during the last 7 days, on 
how many days did you walk for at least 10 minutes at a time in your leisure 
time? 
                 days per week 
☐ No walking in leisure time → skip to question 22 
 
21. How much time did you usually spend on one of those days walking in your lei-
sure time? 
                 hours per day 
                 minutes per day 
 
22. Think about only those physical activities that you did for at least 10 minutes at a 
time. During the last 7 days, on how many days did you do vigorous physical ac-
tivities like aerobics, running, fast bicycling, or fast swimming in your leisure 
time? 

Version 1.0     19 DEC 2021 
 
                 days per week 
☐ No vigorous activity in leisure time → skip to question 24 
 
23. How much time did you usually spend on one of those days doing vigorous physi-
cal activities in your leisure time? 
                 hours per day 
                 minutes per day 
 
24. Again, think about only those physical activities that you did for at least 10 
minutes at a time. During the last 7 days, on how many days did you do moder-
ate physical activities like bicycling at a regular pace, swimming at a regular pace, 
and doubles tennis in your leisure time? 
                 days per week 
☐ No moderate activity in leisure time → skip to part 5: time spent sitting 
 
25. How much time did you usually spend on one of those days doing moderate 
physical activities in your leisure time? 
                 hours per day 
                 minutes per day 
 
 
Part 5: Time spent sitting 
 
The last questions are about the time you spend sitting while at work, at home, while do-
ing course work and during leisure time. This may include time spent sitting at a desk, 
visiting friends, reading or sitting or lying down watching television. Do not include any 
time spent sitting in a motor vehicle that you have already told me about. 
 
26. During the last 7 days, how much time did you usually spend sitting on a week-
day? 
                 hours per day 
                 minutes per day 
 
 
27. During the last 7 days, how much time did you usually spend sitting on a week-
end day? 
                 hours per day 
                 minutes per day 
 
 
 
 

Version 1.0     19 DEC 2021 
 
APPENDIX 6: ROME IV IBS QUESTIONNAIRE (Dutch version) 
 
Beantwoordt u elke vraag alstublieft zo goed mogelijk, tenzij u wordt verzocht een vraag 
over te slaan. 
1. Hoe vaak had u in de afgelopen 3 maanden pijn ergens in uw buik? 
• 
Nooit -> Ga naar vraag 6. 
• 
Minder dan één dag per maand 
• 
Eén dag per maand 
• 
Twee tot drie dagen per maand 
• 
Eén keer per week 
• 
Twee tot drie dagen per week 
• 
Bijna elke dag (vier tot zes dagen per week) 
• 
Elke dag 
• 
Meerdere keren per dag of constant 
 
2. Hoe vaak kwam deze pijn in uw buik voor rond het moment van de ontlasting - net er-
voor, tijdens of kort erna? (Percentage van het totaal aantal keren met pijn) 
• 
0 % Nooit 
• 
10 % 
• 
20 % 
• 
30 % 
• 
40 % 
• 
50 % 
• 
60 % 
• 
70 % 
• 
80 % 
• 
90 % 
• 
100 % Altijd 
 
3. Hoe vaak was uw ontlasting zachter of harder dan normaal wanneer u deze pijn had? 
(Percentage van het totaal aantal keren met pijn) 
• 
0 % Nooit 
• 
10 % 
• 
20 % 
• 
30 % 
• 
40 % 
• 
50 % 
• 
60 % 
• 
70 % 
• 
80 % 
• 
90 % 
• 
100 % Altijd 
 
 

Version 1.0     19 DEC 2021 
 
4. Hoe vaak had u ofwel vaker dan normaal ofwel minder vaak ontlasting dan normaal 
wanneer u deze pijn had? (Percentage van het totaal aantal keren met pijn) 
• 
0 % Nooit 
• 
10 % 
• 
20 % 
• 
30 % 
• 
40 % 
• 
50 % 
• 
60 % 
• 
70 % 
• 
80 % 
• 
90 % 
• 
100 % Altijd 
5. Is het 6 maanden of langer dat u deze pijn begon te hebben? 
• 
Nee 
• 
Ja 
 
 
6. Wanneer u in de afgelopen 3 maanden abnormale ontlasting had, hoe zag het er dan 
meestal uit? 
• 
Meestal constipatie (zoals type 1 of 2 in de afbeelding) 
• 
Meestal diarree (zoals type 6 of 7) 
• 
Zowel diarree als constipatie, dat wil zeggen: meer dan ¼ van de abnormale ontlas-
ting was constipatie en meer dan ¼ was diarree 
Niet van toepassing, omdat ik zelden of nooit abnormale ontlasting had 
 
 

Version 1.0     19 DEC 2021 
 
APPENDIX 7: IBS Symptom Severity Scale (IBS-SSS) (Dutch version) 
 
1a. Hebt u in de afgelopen 10 dagen last gehad van buikpijn/maagpijn? 
 Nee →   Ga naar vraag 3a 
 Ja  
 
1b. Hoe hevig was uw buikpijn/maagpijn in de afgelopen 10 dagen?  
(Geef een getal aan van 0 tot 100, waarbij 0 ‘geen pijn’ betekent en 100 ‘heel hevige 
pijn’) 
 0 Geen  pijn 
 10  
 20  
 30  
 40  
 50  
 60  
 70  
 80  
 90  
 100 Heel hevige pijn 
 
2. Geef aan hoeveel dagen u van de afgelopen 10 dagen buikpijn heeft gehad.  
(Als u bijvoorbeeld 4 aangeeft, heeft u 4 van de 10 dagen pijn gehad) Als u elke dag pijn 
had, voer dan 10 in). 
 0 dagen 
 1  
 2  
 3  
 4  
 5  
 6  
 7  
 8  
 9  
 10 dagen  
 
3a. Hebt u de afgelopen 10 dagen last gehad van een opgezette buik (opgeblazen, ge-
zwollen of gespannen buik of maagstreek)?           
Vrouwen: Tel opgezetheid vanwege uw menstruatie niet mee wanneer u deze vraag be-
antwoordt. 
 Nee →   Ga naar vraag 4 
 Ja  
 
 

Version 1.0     19 DEC 2021 
 
3b. Hoe erg was uw opgezette/gespannen buik in de afgelopen 10 dagen?  
(Geef een getal aan van 0 tot 100, waarbij 0 'niet opgezet' betekent en 100 'heel hevig 
opgezet') 
 0 -- niet opgezet  
 10  
 20  
 30  
 40  
 50  
 60  
 70  
 80  
 90  
 100 -- heel hevig opgezet  
 
4. Hoe ontevreden bent u over het functioneren van uw darmen in de afgelopen 10 da-
gen?  
(Geef een getal aan van 0 tot 100, waarbij 0 ‘niet ontevreden’ betekent en 100 ‘heel onte-
vreden’) 
 0 -- niet ontevreden 
 10  
 20  
 30  
 40  
 50  
 60  
 70  
 80  
 90  
 100 -- heel ontevreden 
 
5. Hoe erg heeft de buikpijn of het ongemak in uw buik of het anders functioneren van 
uw darmen uw leven in het algemeen beïnvloed of belemmerd in de afgelopen 10 dagen?  
(Geef een getal aan van 0 tot 100, waarbij 0 ‘helemaal niet’ betekent en 100 ‘volledig’) 
 0 -- helemaal niet 
 10  
 20  
 30  
 40  
 50  
 60  
 70  
 80  
 90  
 100 -- volledig  
 
 

 
 
 
 
Version X.X, DD/MMM/YYYY 
 
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Appendix 8: Four Day Food Diary example (Dutch version) 
 
4-daags voedingsdagboek 
 
Het voedingsdagboek zal ons helpen om een inzicht te krijgen in uw voedingspa-
troon.  Schrijf daarom gedurende 4 dagen op wat u precies eet en drinkt, kies 3 
weekdagen en 1 weekenddag.  Eet en drink gedurende deze dagen zo normaal 
mogelijk, vermijd geen voedingsmiddelen en ga ook niet ineens anders eten dan 
gewoonlijk.   
 
Bekijk het voorbeeld op de volgende pagina. 
 
Schrijf meteen alles op, direct opschrijven voorkomt dat u dingen zou vergeten.  U 
neemt het voedingsdagboek dus best overal mee gedurende deze 4 dagen. 
 
Noteer zo duidelijk mogelijk op hetgeen u eet of drinkt : hoeveelheid (portie-
grootte of gewicht) is belangrijk maar ook zoveel mogelijk info over de voeding 
zelf (bv wit of grijs brood, volle of halfvolle melk, gewone of light frisdrank, ….)  U 
mag zeker ook merknamen vermelden of een etiket toevoegen. 
 
Vergeet ook niet snacks en drankjes tussendoor te vermelden. 
 
 

 
 
 
 
Version X.X, DD/MMM/YYYY 
 
34/X| P a g e  
 
Voorbeelddag 
 
 
Tijdstip 
 
wat gegeten/gedronken  
 
 
hoeveelheid 
 
 
ontbijt 
 
 
granola (Dr Oetker) 
 
 
30 g 
 
 
 
Halfvolle natuuryoghurt  
 
 
1 potje van 125 g 
 
 
 
Koffie met halfvolle melk en zoetstof 
1 tas, scheutje melk,  
1tablet zoetstof 
 
tussendoor  
banaan 
 
 
 
 
 
1 volledige 
 
 
 
Water  
 
 
 
 
 
1 glas 
 
middag 
 
meergranenbrood  
 
 
 
4 sneden van een 
groot rond brood  
 
 
 
Minarine 
 
 
 
 
 
dun gesmeerd 
 
 
 
Light smeerkaas  
 
 
 
2 driehoekjes 
 
 
 
Salami 
 
 
 
 
 
2 sneetjes 
 
 
 
Groentesoep 
 
 
 
 
1 grote soepbol 
 
 
 
Cola light 
 
 
 
 
 
1 blikje 330 ml 
 
tussendoor  
suikerwafel met chocolade (Suzy)  
 
55g (kijk op  
verpakking) 
 
 
 
Thee citroen  
 
 
 
 
1 tas 
 
avondmaal  
blinde vink  
 
 
 
 
1 stuk 
 
 
 
Bloemkool in bechamel  
 
 
1/3 van het bord,  
bechamelsaus bereid met half- 
 
 
 
 
 
 
 
 
 
 
Volle melk 
Natuuraardappelen 
 
 
 
3 stuks grootte van  
een ei 
Margarine voor bakken en braden 
 
2 eetlepels voor  
maaltijd 4 personen 
Rode wijn 
 
 
 
 
 
1 glas 
 
tussendoor  
vanillepudding bereid met halfvolle  
dessertschaaltje 
 
 
 
melk en suiker