Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2025-12-25 @ 8:18 PM
Study NCT ID:
NCT05293769
Status:
RECRUITING
Last Update Posted:
2025-12-18
First Post:
2021-10-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
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
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D043183', 'term': 'Irritable Bowel Syndrome'}], 'ancestors': [{'id': 'D003109', 'term': 'Colonic Diseases, Functional'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2030-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-11', 'studyFirstSubmitDate': '2021-10-27', 'studyFirstSubmitQcDate': '2022-03-22', 'lastUpdatePostDateStruct': {'date': '2025-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-03-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To validate the newly developed food frequency questionnaire against the standard 4-day food diary across different populations', 'timeFrame': '2 years'}], 'secondaryOutcomes': [{'measure': 'Comparison of dietary and FODMAP intake in IBS vs. non-IBS patients in different populations', 'timeFrame': '2 years', 'description': 'differences in number and type of FODMAP intake between groups'}, {'measure': 'Comparison of the degree of physical activity in IBS vs. non-IBS patients in different populations', 'timeFrame': '2 years', 'description': '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'}, {'measure': 'Comparison of the degree of physical activity and IBS symptom severity in different populations', 'timeFrame': '2 years', 'description': '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'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Irritable Bowel Syndrome']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy subjects, IBS patients', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 - 65 years;\n* Provide written informed consent;\n* Living in Belgium\n\nExclusion Criteria:\n\n* Diet \\< 8 weeks prior to participation;\n* Known or suspected eating disorder;\n* Major psychiatric disorder;\n* Known gastro-intestinal disease (IBS is allowed);\n* Any malignancy in the past 3 years (basocellular carcinoma is allowed);\n* Chemotherapy in the past 6 months;\n* 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);\n* Previous abdominal surgery (appendectomy and cholecystectomy are allowed);\n* Alcohol abuse defined as \\> 14 U per week;\n* Use of illicit drugs;\n* Intake of drugs with known major gastro-intestinal side effects.\n* Initiation of neuromodulators less than 3 months before participation. Neuromodulators are allowed when taken at a stable dose for at least 3 months;\n* Pregnancy.'}, 'identificationModule': {'nctId': 'NCT05293769', 'briefTitle': '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', 'organization': {'class': 'OTHER', 'fullName': 'Universitair Ziekenhuis Brussel'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'FaST'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'IBS - arm', 'interventionNames': ['Other: questionnaire']}, {'label': 'healthy - arm', 'interventionNames': ['Other: questionnaire']}], 'interventions': [{'name': 'questionnaire', 'type': 'OTHER', 'description': 'questionnaire will be filled in by all participants', 'armGroupLabels': ['IBS - arm', 'healthy - arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Jette', 'state': 'Brussels Capital', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Sébastien Kindt', 'role': 'CONTACT', 'phone': '+32 2 477 60 11'}], 'facility': 'UZ Brussel', 'geoPoint': {'lat': 50.87309, 'lon': 4.33419}}], 'centralContacts': [{'name': 'Sébastien Kindt', 'role': 'CONTACT', 'email': 'Sebastien.kindt@uzbrussel.be', 'phone': '+32 2 477', 'phoneExt': '60 11'}, {'name': 'Virgini Van Buggenhout', 'role': 'CONTACT', 'email': 'virgini.vanbuggenhout@uzbrussel.be', 'phone': '+32 2 477', 'phoneExt': '60 11'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitair Ziekenhuis Brussel', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}