Irritable Bowel SyndromeNCT05293769
Reliability of a Food Frequency Questionnaire in the Assessment of Dietary Intake Including FODMAPs in Different Populations, and Relationship With IBS Symptoms and the Degree of Self-assessed Physical Activity
An observational study of Irritable Bowel Syndrome, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial summary
During an online assessment participants will fill in questionnaires evaluating demographic data, psychological variables, the degree of self-assessed physical activity and symptoms of irritable bowel. Dietary intake will be assessed by a newly developed food frequency questionnaire (FFQ) and a 4 days food diary. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- questionnaire
- How many people
- 400 participants
- Where
- 1 siteBelgium
- Study dates
- 15 Oct 2022to 31 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Adult, Older adult
Study population: Healthy subjects, IBS patients
Who may be able to join
- 18 - 65 years;
- Provide written informed consent;
- Living in Belgium
Who cannot join
- Diet < 8 weeks prior to participation;
- Known or suspected eating disorder;
- Major psychiatric disorder;
- Known gastro-intestinal disease (IBS is allowed);
- Any malignancy in the past 3 years (basocellular carcinoma is allowed);
- Chemotherapy in the past 6 months;
Show all 13Show fewer
- Infectious gastro-enteritis in the past 6 months (infectious gastro-enteritis defined as the concurrent presence of one of the following signs during 2 or more consecutive days: fever, vomiting, sudden onset of diarrhea, hospitalization because of these symptoms);
- Previous abdominal surgery (appendectomy and cholecystectomy are allowed);
- Alcohol abuse defined as > 14 U per week;
- Use of illicit drugs;
- Intake of drugs with known major gastro-intestinal side effects.
- Initiation of neuromodulators less than 3 months before participation. Neuromodulators are allowed when taken at a stable dose for at least 3 months;
- Pregnancy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
UZ Brussel
Jette, Brussels Capital, 1090
Sébastien Kindt, +32 2 477 60 11
About this study
Official title: Reliability of a Food Frequency Questionnaire in the Assessment of Dietary Intake Including FODMAPs (Fermentable Oligosaccharides, Disaccharides, Monosaccharides and Polyols) in Different Populations, and Relationship With IBS (Inflammatory Bowel Syndrome) Symptoms and the Degree of Self-assessed Physical Activity
During an online assessment participants will fill in questionnaires evaluating demographic data, psychological variables, the degree of self-assessed physical activity and symptoms of irritable bowel. Dietary intake will be assessed by a newly developed food frequency questionnaire (FFQ) and a 4 days food diary. In order to validate the FFQ in different populations, participants will be recruited from university students, staff of UZ Brussel and VUB, and from the community by advertisement (including social media). IBS patients will be recruited from the gastro-enterology outpatient clinic.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- questionnaire
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaireOther
questionnaire will be filled in by all participants
| Study group | Role | What they receive |
|---|---|---|
| IBS - arm | Not described Receives: Other: questionnaire | |
| healthy - arm | Not described Receives: Other: questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
To validate the newly developed food frequency questionnaire against the standard 4-day food diary across different populations
Measured: 2 years
Secondary outcomes (3)
Comparison of dietary and FODMAP intake in IBS vs. non-IBS patients in different populations
differences in number and type of FODMAP intake between groups
Measured: 2 years
Comparison of the degree of physical activity in IBS vs. non-IBS patients in different populations
differences and correlation of IPAQ (International Physical Activity Questionnaire) scores between groups, IPAQ evaluates the level of physical activity. Scoring a HIGH level of physical activity on the IPAQ means your physical activity levels equate to approximately one hour of activity per day or more
Measured: 2 years
Comparison of the degree of physical activity and IBS symptom severity in different populations
differences and correlation of IPAQ scores between groups; IPAQ evaluates the level of physical activity. Scoring a HIGH level of physical activity on the IPAQ means your physical activity levels equate to approximately one hour of activity per day or more
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2022
- Study start15 Oct 2022
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05293769
- Sponsor's protocol ID
- FaST
- Status last verified
- Dec 2025
- First submitted
- 27 Oct 2021
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability of a Food Frequency Questionnaire in the Assessment of Dietary Intake Including FODMAPs (Fermentable Oligosaccharides, Disaccharides, Monosaccharides and Polyols) in Different Populations, and Relationship With IBS (Inflammatory Bowel Syndrome) Symptoms and the Degree of Self-assessed Physical Activity
- ClinicalTrials.gov ID
- NCT05293769
- Acronym / sponsor ID
- FaST
- Conditions
- Irritable Bowel Syndrome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- 15 Oct 2022 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 24 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
During an online assessment participants will fill in questionnaires evaluating demographic data, psychological variables, the degree of self-assessed physical activity and symptoms of irritable bowel. Dietary intake will be assessed by a newly developed food frequency questionnaire (FFQ) and a 4 days food diary. In order to validate the FFQ in different populations, participants will be recruited from university students, staff of UZ Brussel and VUB, and from the community by advertisement (including social media). IBS patients will be recruited from the gastro-enterology outpatient clinic.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IBS - arm | – | Other: questionnaire |
| healthy - arm | – | Other: questionnaire |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Healthy subjects, IBS patients
Key inclusion criteria (3 listed)
- 18 - 65 years;
- Provide written informed consent;
- Living in Belgium
Key exclusion criteria (13 listed)
- Diet < 8 weeks prior to participation;
- Known or suspected eating disorder;
- Major psychiatric disorder;
- Known gastro-intestinal disease (IBS is allowed);
- Any malignancy in the past 3 years (basocellular carcinoma is allowed);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnairequestionnaire will be filled in by all participants | Other | IBS - arm, healthy - arm |
Primary outcome
To validate the newly developed food frequency questionnaire against the standard 4-day food diary across different populations
Time frame: 2 years
3 secondary outcomes
Comparison of dietary and FODMAP intake in IBS vs. non-IBS patients in different populations
Time frame: 2 years
Comparison of the degree of physical activity in IBS vs. non-IBS patients in different populations
Time frame: 2 years
Comparison of the degree of physical activity and IBS symptom severity in different populations
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Irritable Bowel Syndrome, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sébastien Kindt (+32 2 477 ext. 60 11, Sebastien.kindt@uzbrussel.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To validate the newly developed food frequency questionnaire against the standard 4-day food diary across different populations (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.