Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 10:45 PM
Study NCT ID:
NCT04913467
Status:
UNKNOWN
Last Update Posted:
2023-02-14
First Post:
2021-05-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Ileocolonic Delivered Vitamins and an Anti-Inflammatory Diet on Crohn's Disease and Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003424', 'term': 'Crohn Disease'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}], 'ancestors': [{'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized, partly blinded, multicenter clinical food trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 510}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-10-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2025-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-10', 'studyFirstSubmitDate': '2021-05-03', 'studyFirstSubmitQcDate': '2021-05-28', 'lastUpdatePostDateStruct': {'date': '2023-02-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in faecal calprotectin', 'timeFrame': 'Faeces sample collection at 4 time points: At baseline (0 months), after 3 months, after 6 months, after 12 months', 'description': 'Primary outcome for CD patients'}, {'measure': 'Change in microbiome composition measured by metagenomic sequencing- based profiles', 'timeFrame': 'Faeces sample collection at 3 time points: At baseline (0 months), after 3 months, after 12 months', 'description': 'Primary outcome for healthy volunteers and CD patients'}], 'secondaryOutcomes': [{'measure': "The number of flares (defined as faecal calprotectin >200 μg/g and Crohn's Disease Activity Index (CDAI) ≥220 points)", 'timeFrame': 'Faeces sample collection and CDAI score determination at 4 time points: At baseline (0 months), after 3 months, after 6 months, after 12 months', 'description': 'Secondary outcome for CD patients'}, {'measure': 'Improvements of Quality of life scores as assessed by Inflammatory Bowel Disease Questionnaire (Score range of 32-224, The higher the score the higher the Quality of Life)', 'timeFrame': 'Questionnaires at 3 time points: At baseline (0 months), after 3 months, after 12 months', 'description': 'Secondary outcome for CD patients'}, {'measure': 'Improvements of Quality of life scores as assessed Food Related Quality of Life Questionnaire (Score range of 29-145, The higher the score the higher the Food related-Quality of Life)', 'timeFrame': 'Questionnaires at 3 time points: At baseline (0 months), after 3 months, after 12 months', 'description': 'Secondary outcome for CD patients and healthy volunteers'}, {'measure': 'Adherence to the dietary interventions as assessed by a Dietary Compliance Questionnaire', 'timeFrame': 'Questionnaires at 3 time points: At baseline (0 months), after 3 months, after 12 months', 'description': 'Secondary outcome for CD patients and healthy volunteers'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Inflammatory Bowel Disease', 'IBD', 'Crohn', 'Vitamins', 'Diet', 'Riboflavin', 'Ascorbic Acid', 'Niacin', 'Microbiome'], 'conditions': ['Crohn Disease']}, 'referencesModule': {'references': [{'pmid': '36918234', 'type': 'DERIVED', 'citation': "Otten AT, Peters V, Barth I, Stevens CL, Bourgonje AR, Frijlink HW, Harmsen HJM, Rehman A, Campmans-Kuijpers MJE, Dijkstra G. Effects of ileocolonic delivered vitamin B2, B3 and C (ColoVit) or the Groningen anti-inflammatory diet on disease course and microbiome of patients with Crohn's disease (VITA-GrAID study): a protocol for a randomised and partially blinded trial. BMJ Open. 2023 Mar 14;13(3):e069654. doi: 10.1136/bmjopen-2022-069654."}]}, 'descriptionModule': {'briefSummary': "This study will evaluate if the Groningen Anti-Inflammatory Diet and the ileocolonic delivery of vitamin B2, B3 and C can positively influence the course of Crohn's disease and can positively alter the gut microbiome of Crohn's disease patients as well as healthy volunteers.", 'detailedDescription': "It is becoming increasingly more well known that diet and the microbiome have a pivotal role in the development and course of inflammatory bowel diseases (IBD). Strict exclusive enteral nutrition (EEN) can induce remission in Crohn's Disease (CD) and is the standard treatment in paediatric CD. Implementing a restrictive diet in adults is difficult; adult patients do not tend to adhere to EEN. Recently, the CD-exclusion diet (CDED) combined with partial enteral nutrition demonstrated to be effective in CD-patients with flares.\n\nAdditionally, accumulating evidence suggests that intake of vitamins can influence disease course, mainly by beneficially modulating the gut microbiota and gut redox potential, especially if the vitamins can be delivered to the colon.\n\nNevertheless, no dietary guidelines are available to physicians and patients. Due to complaints of certain foods and patients' eagerness to postpone new flares, patients start experimenting with their food. As patients with CD are already often malnourished, this poorly substantiated experimenting puts them even more at risk for malnutrition and could have a potential negative effect on their disease outcomes. Next, quality of life of patients decreases and healthcare costs will rise. Therefore, both patients and physicians are in desperate need of evidence for an anti-inflammatory dietary advice in CD. As compliance to a diet increases when they are supported by family members, their household members will also be asked to participate in the study. Simultaneously studying their healthy family members will also provide information of the effect of this anti-inflammatory diet or intake of lieocolonic-delivered vitamins on their microbiome and markers of inflammation and oxidative stress."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria CD patients:\n\n* Participant understands the study procedures and signed an informed consent to participate in this study\n* Previously diagnosed with CD; Montreal classification: L1 (Ileal), L2 (colonic), or L3 (ileocolonic).\n* Low-mild disease activity (no clinically relevant symptoms and HBI\\<8 or CDAI \\<220)\n* Evidence of mucosal inflammation (faecal calprotectin ≥100 μg/g)\n* Able to attend to the outpatient clinic of the UMCG, Martini Hospital, MCL Leeuwarden or Isala\n* ≥18 years of age\n* Able to use oral feeding and willing to undergo a dietary intervention (Follow a diet or use a vitamin B2/B3/C supplement or placebo)\n\nInclusion Criteria healthy volunteers:\n\n* Participant understands the study procedures and signed an informed consent to participate in this study\n* Never been diagnosed with IBD or any other chronic inflammatory condition.\n* Participant has no health conditions that would prevent him/her from fulfilling the study requirements as judged by the investigator on the basis of medical history and routine laboratory test results.\n* Able to attend to the outpatient clinic of the UMCG, Martini Hospital, MCL Leeuwarden or Isala\n* ≥18 year of age\n* Able to use oral feeding and willing to undergo a dietary intervention (Follow a diet or use a vitamin B2/B3/C supplement or placebo)\n\nExclusion Criteria CD patients:\n\n* Life expectancy \\<12 months\n* Active Crohn's disease (HBI≥8 or CDAI\\>220), or expecting drug intervention within 3 months\n* Colonoscopy and colon cleansing in the past 3 months;\n* Use antibiotics, probiotics (eg Yakult, Vifit, Activia) or specific prebiotics supplements 3 weeks prior to the start of the intervention\n* Use of vitamin/mineral supplements 1 week prior to the start of the intervention (except for vitamin D and/or calcium)\n* Use Methotrexate drugs or chronic use of antacids, H2 or proton-pump inhibitors\n* With a history of GI disorders or GI surgery that are likely to interfere with the pH-dependent mode of action of the Colovit-capsule\n* Patients with a pouch or stoma\n* Pregnant or breastfeeding (or foreseen pregnancy during dietary intervention period)\n* Swallowing disorders, not able to tolerate oral food, or use of tube feeding (EEN)\n* Previously proven anaphylactic reaction to foods included in the food boxes\n* Previously diagnosed with Celiac Disease or following a gluten-free diet\n* Following a vegetarian or vegan diet\n\nExclusion Criteria healthy subjects:\n\n* Life expectancy \\<12 months\n* Previously diagnosed with IBD or any other chronic inflammatory condition\n* Colonoscopy and colon cleansing in the past 3 months;\n* Use antibiotics, probiotics (eg Yakult, Vifit, Activia) or specific prebiotics supplements 3 weeks prior to the start of the intervention\n* Use of vitamin/mineral supplements 1 week prior to the start of the intervention (except for vitamin D and/or calcium)\n* With a history of GI disorders or taken drugs that are likely to interfere with mode of action of interventions, such as chronic use of antacids or proton-pump inhibitors\n* Abnormal clinical chemistry and haematology laboratory test results of clinical significance that in the judgment of the investigator would interfere with the participant's ability to comply with the study protocol (which might confound the interpretation of the study results), or put the participant at undue risk.\n* Presence of a stoma\n* History or presence of cancer in the prior two years, except for non-melanoma skin cancer.\n* Recent history of (within 12 months of screening visit) or strong potential for alcohol or substance abuse. Alcohol abuse is defined as \\>60g (men) / 40g (women) pure alcohol per day (1.5 l / 1 l beer resp. 0.75 l / 0.5 l wine).\n* Pregnant or breastfeeding (or foreseen pregnancy during dietary intervention period) The method of contraception must be recorded in the source documentation.\n* Swallowing disorders, not able to tolerate oral food, or use of tube feeding (EEN)\n* Previously proven anaphylactic reaction to foods included in the food boxes\n* Previously diagnosed with Celiac Disease or following a gluten-free diet\n* Following a vegetarian or vegan diet"}, 'identificationModule': {'nctId': 'NCT04913467', 'acronym': 'Vita-GrAID', 'briefTitle': "Effect of Ileocolonic Delivered Vitamins and an Anti-Inflammatory Diet on Crohn's Disease and Healthy Volunteers", 'organization': {'class': 'OTHER', 'fullName': 'University Medical Center Groningen'}, 'officialTitle': "Potential Effects of Ileocolonic Delivered Vitamins or the Groningen Anti-Inflammatory Diet on Course of Crohn's Disease and the Microbiome of Healthy Volunteers: a Randomized Controlled Trial - The Vita-GrAID Study", 'orgStudyIdInfo': {'id': 'NL66008.056.20'}, 'secondaryIdInfos': [{'id': '202000683', 'type': 'OTHER', 'domain': 'UMCG'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Groningen Anti-Inflammatory Diet (GrAID)', 'description': 'Specially designed diet based on the most recent scientific evidence of the inflammatory characteristics of food and food groups.', 'interventionNames': ['Other: Groningen Anti-Inflammatory Diet (GrAID)']}, {'type': 'EXPERIMENTAL', 'label': 'ColoVit capsule', 'description': '2 times daily intake of a supplement containing 37,5 mg vitamin B2, 2,5 mg vitamin B3 and 250 mg vitamin C in a ColoPulse-coated capsule, a pH-sensitive coating allowing ileocolonic-targeted-delivery', 'interventionNames': ['Dietary Supplement: ColoVit capsule']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo capsule', 'description': '2 times daily intake of a capsule containing microcrystalline cellulose which is coated using the same ColoPulse technology as is used with the ColoVit', 'interventionNames': ['Other: ColoPulse-placebo capsule']}], 'interventions': [{'name': 'Groningen Anti-Inflammatory Diet (GrAID)', 'type': 'OTHER', 'description': 'Specially designed diet based on the most recent scientific evidence of the inflammatory characteristics of food and food groups. Basically, subjects will be instructed to increase uptake of food components that hold potential anti-inflammatory proportions and to avoid food components that may showcase potential pro-inflammatory proportions.', 'armGroupLabels': ['Groningen Anti-Inflammatory Diet (GrAID)']}, {'name': 'ColoVit capsule', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Vitamin B2/B3/C supplement in a ColoPulse-coated capsule', 'armGroupLabels': ['ColoVit capsule']}, {'name': 'ColoPulse-placebo capsule', 'type': 'OTHER', 'description': 'A capsule containing microcrystalline cellulose which is coated using the same ColoPulse technology as is used with the ColoVit', 'armGroupLabels': ['Placebo capsule']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9713GZ', 'city': 'Groningen', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Gerard Dijkstra, Md PhD', 'role': 'CONTACT', 'email': 'gerard.dijkstra@umcg.nl', 'phone': '+31 050 3612620'}], 'facility': 'University Medical Center Groningen', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}], 'centralContacts': [{'name': 'Gerard Dijkstra, MD PhD', 'role': 'CONTACT', 'email': 'gerard.dijkstra@umcg.nl', 'phone': '+31 050 3612620'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is no plan to make individual participant data available to other researchers outside of the study team.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Medical Center Groningen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor, Head of Inflammatory Bowel Disease Center and Intestinal Transplantation Center', 'investigatorFullName': 'Prof. dr. G. Dijkstra', 'investigatorAffiliation': 'University Medical Center Groningen'}}}}