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RecruitingNCT05293769Updated Dec 18, 2025

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 in Irritable Bowel Syndrome, sponsored by Universitair Ziekenhuis Brussel. Recruiting at 1 site in Belgium. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-12-18.

Sponsored by Universitair Ziekenhuis Brussel · Observational

From the registry’s dates

  • Started Oct 2022; still recruiting 3 years 11 months later.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
400
Ages
18 Years to 65 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Irritable Bowel Syndrome
03

In context

Irritable Bowel Syndrome

1,062 studies on the registry are indexed under Irritable Bowel Syndrome; 190 are open to participants now.

This study's planned enrollment of 400 is above the median of 150 across 178 observational studies indexed under Irritable Bowel Syndrome.

Browse Irritable Bowel Syndrome studies →

Lead sponsor

Universitair Ziekenhuis Brussel is the lead sponsor of 362 studies on the registry; 103 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Healthy subjects, IBS patients

Inclusion criteria

  • 18 - 65 years;
  • Provide written informed consent;
  • Living in Belgium

Exclusion criteria

Exclusion Criteria:

  • 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;
  • 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.
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
400 participants (estimated)
Patient registry
No

Groups and cohorts

  • IBS - arm

    Other: questionnaire

  • healthy - arm

    Other: questionnaire

Interventions

  • Otherquestionnaire

    questionnaire will be filled in by all participants

06

What researchers measure

Primary outcomes

  1. To validate the newly developed food frequency questionnaire against the standard 4-day food diary across different populations

    Time frame: 2 years

Secondary outcomes

  1. 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

    Time frame: 2 years

  2. 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

    Time frame: 2 years

  3. 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

    Time frame: 2 years

07

Study locations

1 of 1 sites recruiting
  • UZ Brussel
    Jette, Brussels Capital 1090, Belgium
    • Sébastien Kindt · Contact · +32 2 477 60 11
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 18, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05293769
Lead sponsor
Universitair Ziekenhuis Brussel
Responsible party
Sponsor
First posted
Mar 24, 2022
Start date
Oct 15, 2022
Primary completion
Dec 31, 2030 (estimated)
Completion
Dec 31, 2030 (estimated)
Last update
Dec 18, 2025

Study contacts

Sébastien Kindt
Contact
Sebastien.kindt@uzbrussel.be
+32 2 477 ext. 60 11
Virgini Van Buggenhout
Contact
virgini.vanbuggenhout@uzbrussel.be
+32 2 477 ext. 60 11

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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