NCT05293769 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
| NCT ID | NCT05293769 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universitair Ziekenhuis Brussel |
| Condition | Irritable Bowel Syndrome |
| Study Type | OBSERVATIONAL |
| Enrollment | 400 participants |
| Start Date | 2022-10-15 |
| Primary Completion | 2030-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 400 participants in total. It began in 2022-10-15 with a primary completion date of 2030-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * 18 - 65 years; * Provide written informed consent; * Living in Belgium 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05293769 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Irritable Bowel Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05293769 currently recruiting?
Yes, NCT05293769 is actively recruiting participants. Contact the research team at Sebastien.kindt@uzbrussel.be for enrollment information.
Where is the NCT05293769 trial being conducted?
This trial is being conducted at Jette, Belgium.
Who is sponsoring the NCT05293769 clinical trial?
NCT05293769 is sponsored by Universitair Ziekenhuis Brussel. The trial plans to enroll 400 participants.