NCT05293769

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
57mo left

Started Oct 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress43%
Oct 2022Dec 2030

First Submitted

Initial submission to the registry

October 27, 2021

Completed
5 months until next milestone

First Posted

Study publicly available on registry

March 24, 2022

Completed
7 months until next milestone

Study Start

First participant enrolled

October 15, 2022

Completed
8.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Last Updated

December 18, 2025

Status Verified

December 1, 2025

Enrollment Period

8.2 years

First QC Date

October 27, 2021

Last Update Submit

December 11, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

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

    2 years

Secondary Outcomes (3)

  • Comparison of dietary and FODMAP intake in IBS vs. non-IBS patients in different populations

    2 years

  • Comparison of the degree of physical activity in IBS vs. non-IBS patients in different populations

    2 years

  • Comparison of the degree of physical activity and IBS symptom severity in different populations

    2 years

Study Arms (2)

IBS - arm

Other: questionnaire

healthy - arm

Other: questionnaire

Interventions

questionnaire will be filled in by all participants

IBS - armhealthy - arm

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy subjects, IBS patients

You may qualify if:

  • years;
  • Provide written informed consent;
  • Living in Belgium

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZ Brussel

Jette, Brussels Capital, 1090, Belgium

RECRUITING

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 27, 2021

First Posted

March 24, 2022

Study Start

October 15, 2022

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2030

Last Updated

December 18, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations