Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2026-01-29 @ 5:31 PM
Study NCT ID:
NCT02469220
Status:
COMPLETED
Last Update Posted:
2022-04-27
First Post:
2015-06-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diet Treatment of Patients With Ulcerative Colitis in Remission
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003093', 'term': 'Colitis, Ulcerative'}], 'ancestors': [{'id': 'D003092', 'term': 'Colitis'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000092622', 'term': 'FODMAP Diet'}], 'ancestors': [{'id': 'D000092724', 'term': 'Elimination Diets'}, {'id': 'D004032', 'term': 'Diet'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2022-04-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-26', 'studyFirstSubmitDate': '2015-06-08', 'studyFirstSubmitQcDate': '2015-06-10', 'lastUpdatePostDateStruct': {'date': '2022-04-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-06-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gastrointestinal symptoms', 'timeFrame': 'Week 8', 'description': 'IBS-SSS questionnaire'}], 'secondaryOutcomes': [{'measure': 'Change in Quality of life', 'timeFrame': 'Week 8', 'description': 'SF-36 questionnaire'}, {'measure': 'Pain diary', 'timeFrame': 'Daily during the study', 'description': 'VAS scales on a daily basis'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diet', 'low FODMAP', 'UC', 'IBS'], 'conditions': ['Ulcerative Colitis']}, 'descriptionModule': {'briefSummary': 'The study examines the effect of a low FODMAP diet in patients with UC in remission but still having GI symptoms (IBS in IBD). 15 patients will be on watchful waiting. 15 patients will be on low FODMAP diet. 15 patients with recieve FODMAPs in their diet.', 'detailedDescription': 'Patients are randomized to either standard care, low FODMAP diet or a normal FODMAP diet. Run-in on a low FODMAP diet, thereafter parallel design where one arm is assign a blinded food supplement with low FODMAP content and the other arm is assigned a blinded food supplement containing FODMAP. A control group is "watchful waiting".\n\nSymptom reports, blood, and fecal samples are collected.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Colitis ulcerosa in remission (calciprotectin\\<200 and normal sigmoidoscopy)\n* ROM IV criteria fullfilled\n* Stable medical therapy\n\nExclusion Criteria:\n\n* Intake of a low FODMAP diet within the past 6 weeks prior to baseline\n* Atypical colitis ulcerosa primarily right sided disease and calciprotectin \\>50 unless normal sigmoidoscopy\n* If diarrhea: Clostridium difficile infection\n* Lactose intolerance\n* Systemisk or local treatment for CU other than 5-aminosalicylicacid or biological therapy\n* Antibiotics within 6 weeks\n* Pregnancy\n* Activity in UC\n* Coeliac disease\n* Abnormal transglutaminase\n* Eating disorder\n* Special diet preventing the low FODMAP diet\n* Other GI disease or other disease explaining symptoms\n* Medication intake explaining symptoms\n* Not able to follow protocol'}, 'identificationModule': {'nctId': 'NCT02469220', 'briefTitle': 'Diet Treatment of Patients With Ulcerative Colitis in Remission', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Regionshospital Nordjylland'}, 'officialTitle': 'Diet Treatment of Patients With Ulcerative Colitis in Remission', 'orgStudyIdInfo': {'id': 'RHN_ALK_01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Low FODMAP diet', 'description': 'Diet with a low content of fermentable oligo-, di-, monosaccharides and polyols (low FODMAP diet). The patients will receive dietary instructions from registered clinical dieticians. A food supplement low in FODMAPS are administered in a blinded fashion.', 'interventionNames': ['Dietary Supplement: Low FODMAP']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standardized FODMAP', 'description': 'Diet with a low content of fermentable oligo-, di-, monosaccharides and polyols (low FODMAP diet). The patients will receive dietary instructions from registered clinical dieticians. A food supplement with FODMAPS are administered in a blinded fashion.', 'interventionNames': ['Dietary Supplement: Standardized FODMAP']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Watchful waiting. No diets or food supplements are administered'}], 'interventions': [{'name': 'Low FODMAP', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Blinded food supplements containing only items with a low content of FODMAPs', 'armGroupLabels': ['Low FODMAP diet']}, {'name': 'Standardized FODMAP', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Blinded food supplements containing FODMAPs', 'armGroupLabels': ['Standardized FODMAP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9800', 'city': 'Hjørring', 'state': 'North Denmark', 'country': 'Denmark', 'facility': 'North Denmark Regional Hospital', 'geoPoint': {'lat': 57.46417, 'lon': 9.98229}}], 'overallOfficials': [{'name': 'Anne L Krarup, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Regionshospital Nordjylland'}, {'name': 'Jeanette Soerensen, PhD-student', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Regionshospital Nordjylland'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Regionshospital Nordjylland', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Anne Lund Krarup', 'investigatorAffiliation': 'Regionshospital Nordjylland'}}}}