Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-30 @ 3:21 AM
Study NCT ID:
NCT07389161
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-05
First Post:
2025-12-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Uneven Nutrition and Life Style as IBD Triggers in Adolescents and Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003093', 'term': 'Colitis, Ulcerative'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}], 'ancestors': [{'id': 'D003092', 'term': 'Colitis'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Sequential Assignment Prospective non-randomized intevention study where everyone serves as their own control'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2029-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-30', 'studyFirstSubmitDate': '2025-12-16', 'studyFirstSubmitQcDate': '2026-01-30', 'lastUpdatePostDateStruct': {'date': '2026-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Sleep quality', 'timeFrame': 'Four weeks.', 'description': 'Activity bracelets will be used for measurements of sleep quality: This is based on a value that is a combination of time for sleep onset (minutes, shorter is better), the number of awakenings (fewer is better) and the amount of REM sleep during the night (minutes, more is better). A cut-off level is not appropriate. It is indvidual and must be based both on absolute outcome and relative change.'}], 'primaryOutcomes': [{'measure': 'Microbial composition', 'timeFrame': 'Four weeks', 'description': 'Gut microbiota will be analyzed at start and after four weeks. The health promoting efect of the diet will be estimated with analysis of the total bacterial genome down to species level. The bacterial composition will then be analyzed with regard to presence of beneficial or harmful bacteria. Based on the complexity of the micorbiota it is not possible to state any specific value that should be achieved.'}], 'secondaryOutcomes': [{'measure': 'Disease activity', 'timeFrame': 'Four weeks', 'description': 'Laboratory data:\n\nCalprotectin (mg/kg); lower level is better.'}, {'measure': 'Disease activity', 'timeFrame': 'Four weeks', 'description': 'Questionnaires:\n\nHarvey-Bradshaw Index (ulcerative colitis). Lower levels are in accordance with lower disease activity.'}, {'measure': 'Disease activity', 'timeFrame': 'Four weeks', 'description': "Questionnaires:\n\nCDAI (Crohn's Disease Activity Index). Lower levels are in accordance with lower disease activity."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diet', 'Inflammatory bowel disease', 'Mb Crohn', 'Ulcerative colitis'], 'conditions': ['Mb Crohn', 'Ulcerative Colitis (UC)']}, 'descriptionModule': {'briefSummary': 'The aims of the study are 1. to determine the effect on dysbiosis, permeability and inflammatory activity after administration of a Mediterranean like diet (a Nordic equivalent, "Nordiet"), 2. to investigate life style related factors, such as exercise, psychosexual health and quality of life and their relation to the disease activity.', 'detailedDescription': 'The project aims, firstly, to map the quality of life and psychosexual health of young IBD patients (18-35 years), secondly, to investigate what treatment effect a changed diet can bring, and thirdly, to investigate whether physical activity and body composition can be related to disease activity.\n\nThe investigators want to use a natural food based on Mediterranean diet without artificial additives to evaluate the effect on the degree of disease activity through analysis of customary clinical parameters such as symptom picture and lab work including calprotectin (in stool samples) but mainly analysis of the gut microbiota and bacterial DNA in the blood as a marker for intestinal health.\n\nPhysical activity can be a possible treatment. By combining activity bracelets with analysis of autonomic balance (heart rate variability) and sleep quality, examinations of symptom burden and inflammatory activity, new valuable knowledge can be obtained.\n\nAssociations have been demonstrated between active IBD, depression, stress, fatigue, quality of life and sexual function in both women and men. It is therefore important to investigate psychosexual health and quality of life among young people with IBD and to also evaluate the effects of intervention through questionnaires and qualitative interviews.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* IBD, i.e., Mb Crohn or ulcerrative colitis\n* Moderatively active disease (calprotectin 200-600)\n\nExclusion Criteria:\n\n* Proctitis alone\n* Inactive disease\n* Severe flare up requiring in-patient care\n* Planned change of treatment\n* Antibiotic treatment during the last month\n* Pregnancy\n* Inability to understand Swedish\n* Multimorbidity'}, 'identificationModule': {'nctId': 'NCT07389161', 'acronym': 'UNITA', 'briefTitle': 'Uneven Nutrition and Life Style as IBD Triggers in Adolescents and Adults', 'organization': {'class': 'OTHER', 'fullName': 'Region Skane'}, 'officialTitle': 'Uneven Nutrition and Life Style as IBD Triggers in Adolescents and Adults', 'orgStudyIdInfo': {'id': '2025-01188-01 UNITA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'Intervention where every one serves as their own control', 'interventionNames': ['Dietary Supplement: Nordiet']}], 'interventions': [{'name': 'Nordiet', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Intervention with a Mediterranean like diet, the so called "Nordiet" during four weeks.', 'armGroupLabels': ['Intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21428', 'city': 'Malmo', 'country': 'Sweden', 'contacts': [{'name': 'Klas Sjöberg, Adj professor', 'role': 'CONTACT', 'email': 'klas.sjoberg@med.lu.se', 'phone': '40336161', 'phoneExt': '+46'}, {'name': 'Vedrana Vejzovic, Associate professor', 'role': 'CONTACT', 'email': 'vedrana.vejzovic@mau.se', 'phone': '40-665 74 46', 'phoneExt': '+46'}, {'name': 'Klas Sjöberg, Adj professor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Skåne University Hospital', 'geoPoint': {'lat': 55.60587, 'lon': 13.00073}}], 'centralContacts': [{'name': 'Klas Sjöberg, Adj professor', 'role': 'CONTACT', 'email': 'klas.sjoberg@med.lu.se', 'phone': '+46 40 33 61 61', 'phoneExt': '+46'}, {'name': 'Vedrana Vejzovic, Associate professor', 'role': 'CONTACT', 'email': 'vedrana.vejzovic@mau.se', 'phone': '+46 40 665 74 46', 'phoneExt': '+46'}], 'overallOfficials': [{'name': 'Vedrana Vejzovic, Associate professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Malmö University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'CSR'], 'timeFrame': '2026 Feb 01 - 2029 Dec 31', 'ipdSharing': 'YES', 'description': 'Data on group level can be shared upon request.', 'accessCriteria': 'In order to establish research cooperation.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Region Skane', 'class': 'OTHER'}, 'collaborators': [{'name': 'Malmö University', 'class': 'OTHER'}, {'name': 'Lund University', 'class': 'OTHER'}, {'name': 'Linkoeping University', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}