Ignite Creation Date:
2025-12-24 @ 2:38 PM
Ignite Modification Date:
2026-01-28 @ 3:31 PM
Study NCT ID:
NCT04082559
Status:
UNKNOWN
Last Update Posted:
2020-10-08
First Post:
2019-08-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biomarker-based Multidisciplinary Team (Bio-MDT) Approach to Personalized Microbial-targeted Treatment of Pouchitis and Crohn's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002939', 'term': 'Ciprofloxacin'}, {'id': 'D008795', 'term': 'Metronidazole'}, {'id': 'D004318', 'term': 'Doxycycline'}, {'id': 'D000900', 'term': 'Anti-Bacterial Agents'}, {'id': 'D004032', 'term': 'Diet'}, {'id': 'D000074584', 'term': 'WW Domain-Containing Oxidoreductase'}, {'id': 'D038441', 'term': 'Diet, Mediterranean'}], 'ancestors': [{'id': 'D024841', 'term': 'Fluoroquinolones'}, {'id': 'D042462', 'term': '4-Quinolones'}, {'id': 'D015363', 'term': 'Quinolones'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009593', 'term': 'Nitroimidazoles'}, {'id': 'D009574', 'term': 'Nitro Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D013754', 'term': 'Tetracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000890', 'term': 'Anti-Infective Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D000074583', 'term': 'Short Chain Dehydrogenase-Reductases'}, {'id': 'D064430', 'term': 'NAD (+) and NADP (+) Dependent Alcohol Oxidoreductases'}, {'id': 'D000429', 'term': 'Alcohol Oxidoreductases'}, {'id': 'D010088', 'term': 'Oxidoreductases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D025521', 'term': 'Tumor Suppressor Proteins'}, {'id': 'D009363', 'term': 'Neoplasm Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000095500', 'term': 'Diet, Plant-Based'}, {'id': 'D004035', 'term': 'Diet Therapy'}, {'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 170}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-06-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2023-06-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-10-06', 'studyFirstSubmitDate': '2019-08-28', 'studyFirstSubmitQcDate': '2019-09-05', 'lastUpdatePostDateStruct': {'date': '2020-10-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time interval to response', 'timeFrame': 'One year', 'description': 'Decrease in PGA and PDAI'}, {'measure': 'Time interval to remission', 'timeFrame': 'One year', 'description': 'PGA=0 and PDAI\\<7'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['IBD'], 'conditions': ['Inflammatory Bowel Diseases']}, 'descriptionModule': {'briefSummary': 'Crohn\'s disease (CD) and ulcerative colitis (UC) are chronic inflammatory bowel diseases (IBD) currently affecting over 5 million patients globally, mostly young adults. These conditions are often debilitating, disabling and may markedly affect patient\'s quality of life. Despite important advances in research, the pathogenesis of IBD remains obscure, the incidence-rising, the condition - incurable, and drugs have a modest effect. The common denominator may be environmental factors, specifically diet and the microbiome, which remain a fundamental unmet need in IBD care as high quality randomized trials and mechanistic research are limited. Up to a quarter of patients with UC may undergo complete large bowel resection due to disease complications. In order to preserve bowel continuity, this surgery includes a restorative part with creation of a reservoir ("pouch") from normal small bowel instead of the resected rectum. The majority of these patients develop small intestinal inflammation in the previously normal small bowel creating the pouch ("pouchitis").\n\nBased on our results from previous studies, we hypothesized that personalized antibiotics and dietary interventions will modify microbial composition and result in significantly improved outcomes, specifically resolution of inflammation and prolonged remission rates in patients with a pouch.\n\nAims:\n\n1. Compare the effect of two antibiotic treatments on clinical, inflammatory and microbiological outcomes of patients with pouch inflammation.\n2. Evaluate the effect of combined microbiome-targeted antibiotic and dietary intervention as treatment and prevention strategy in patients after pouch surgery.\n3. Evaluate the effect of a microbiome-targeted dietary intervention as prevention strategy in patients after pouch surgery.\n4. Identify predictors for response to specific antibiotic and dietary interventions.', 'detailedDescription': 'All patients will undergo comprehensive screening by the bio-MDT.\n\nAim 1: Antibiotic treatment- (patients with active disease) will be randomized to receive a prescription for one of two antibiotic regimens.\n\n1. Ciprofloxacin + metronidazole\n2. Doxycycline+ metronidazole\n\nAim 2: Combination therapy ( Antibiotics+diet) After arm 1 recruitment completion, a favorable antibiotic regimen will be determined and recommended in arm 2, in which, patients with active disease will be randomized to\n\n1. Favorable antibiotics + Mediterranean diet (MED)\n2. Favorable antibiotics + The Specific Carbohydrate Diet (SCD)\n\nAim 3: Nutritional prevention-\n\nPatients in clinical remission will be recruited to a dietary prevention study and be allocated to one of three groups:\n\n1. Mediterranean diet (MED)\n2. Control- based on the American Dietetic Association recommendations for patients with IBD.\n3. Personalized nutrition group- based on prior results from study- NCT02858557\n\nComprehensive assessment including nutritional, clinical, inflammatory and microbial parameters will be performed at baseline and at weeks 2,3,4,8,26, 52.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Patients are able and willing to sign an informed consent\n2. Patients with UC who underwent pouch surgery and have a functioning pouch\n3. Disease activity (PDAI and PGA) according to study arm 1-3 inclusion\n\nExclusion Criteria:\n\n1. Patients with ileostomy\n2. Significant comorbidity that precludes the patient from participating according to the physicians' judgment\n3. Non-Hebrew readers\n4. Pregnant and lactating women"}, 'identificationModule': {'nctId': 'NCT04082559', 'acronym': 'Bio-MDT', 'briefTitle': "Biomarker-based Multidisciplinary Team (Bio-MDT) Approach to Personalized Microbial-targeted Treatment of Pouchitis and Crohn's Disease", 'organization': {'class': 'OTHER', 'fullName': 'Rabin Medical Center'}, 'officialTitle': "Biomarker-based Multidisciplinary Team Approach to Personalized Microbial-targeted Treatment of Pouchitis and Crohn's Disease", 'orgStudyIdInfo': {'id': '0129-19-RMC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Antibiotic treatment', 'description': 'Patients with active disease will be randomized and will receive a prescription for one of two antibiotic regimens.\n\n1. Ciprofloxacin 500 mg 2/d + metronidazole 500 mg 2/d for two weeks\n2. Doxycycline 100 mg 2/d + metronidazole 500 mg 2/d for two weeks', 'interventionNames': ['Other: Arm 1- Antibiotics treatment', 'Other: Arm 2- Antibiotics treatment']}, {'type': 'OTHER', 'label': 'Combination therapy (Antibiotics + diet)', 'description': '1. Favorable antibiotics (according to aim 1) for two weeks + Mediterranean diet (MED) for 8 weeks.\n2. Favorable antibiotics (according to aim 1) for two weeks + specific carbohydrate diet (SCD) for 8 weeks.', 'interventionNames': ['Other: Arm 1- Combination therapy (Antibiotics + diet)', 'Other: Arm 2- Combination therapy (Antibiotics + diet)']}, {'type': 'OTHER', 'label': 'Nutritional prevention', 'description': 'Patients in clinical remission will be recruited to a dietary prevention study.\n\n1. Mediterranean diet\n2. Control- based on the American Dietetic Association recommendations for patients with IBD\n3. Personalized nutrition group- based on prior results from study- NCT02858557', 'interventionNames': ['Other: Arm 1- Nutritional prevention', 'Other: Arm 2- Nutritional prevention', 'Other: Arm 3- Nutritional prevention']}], 'interventions': [{'name': 'Arm 1- Antibiotics treatment', 'type': 'OTHER', 'otherNames': ['Ciprofloxacin 500 mg 2/d + metronidazole 500 mg 2/d for two weeks'], 'description': 'Patients with active disease will be randomized and will receive a prescription antibiotic regimens', 'armGroupLabels': ['Antibiotic treatment']}, {'name': 'Arm 2- Antibiotics treatment', 'type': 'OTHER', 'otherNames': ['Doxycycline 100 mg 2/d + metronidazole 500 mg 2/d for two weeks'], 'description': 'Patients with active disease will be randomized and will receive a prescription antibiotic regimens', 'armGroupLabels': ['Antibiotic treatment']}, {'name': 'Arm 1- Combination therapy (Antibiotics + diet)', 'type': 'OTHER', 'otherNames': ['Favorable antibiotics (according to aim 1) for two weeks + Mediterranean diet (MED) for 8 weeks.'], 'description': 'Patients with active disease receiving a prescription for the antibiotic regimen defined as favorable in the antibiotics according to aim 1 , and randomized into one of two dietary interventions: Mediterranean diet (MED) or the specific carbohydrate diet (SCD).', 'armGroupLabels': ['Combination therapy (Antibiotics + diet)']}, {'name': 'Arm 2- Combination therapy (Antibiotics + diet)', 'type': 'OTHER', 'otherNames': ['Favorable antibiotics (according to aim 1) for two weeks + specific carbohydrate diet (SCD) for 8 weeks.'], 'description': 'Patients with active disease receiving a prescription for the antibiotic regimen defined as favorable in the antibiotics according to aim 1 , and randomized into one of two dietary interventions: Mediterranean diet (MED) or the specific carbohydrate diet (SCD).', 'armGroupLabels': ['Combination therapy (Antibiotics + diet)']}, {'name': 'Arm 1- Nutritional prevention', 'type': 'OTHER', 'otherNames': ['Mediterranean diet'], 'description': 'Patients in clinical remission will be recruited to a dietary prevention study', 'armGroupLabels': ['Nutritional prevention']}, {'name': 'Arm 2- Nutritional prevention', 'type': 'OTHER', 'otherNames': ['Control- based on the American Dietetic Association recommendations for patients with IBD'], 'description': 'Patients in clinical remission will be recruited to a dietary prevention study', 'armGroupLabels': ['Nutritional prevention']}, {'name': 'Arm 3- Nutritional prevention', 'type': 'OTHER', 'otherNames': ['Personalized nutrition group- based on prior results from study- NCT02858557'], 'description': 'Patients in clinical remission will be recruited to a dietary prevention study', 'armGroupLabels': ['Nutritional prevention']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Petah Tikva', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Iris Dotan, Prof', 'role': 'CONTACT', 'email': 'irisdo@clalit.org.il', 'phone': '+97237525015'}, {'name': 'Lihi Godny, BSc', 'role': 'CONTACT', 'email': 'lihigodny@gmail.com', 'phone': '+97237525015'}], 'facility': 'Rabin Medical Center', 'geoPoint': {'lat': 32.08707, 'lon': 34.88747}}], 'centralContacts': [{'name': 'Iris Dotan, Prof', 'role': 'CONTACT', 'email': 'irisdo@clalit.org.il', 'phone': '+97237525015'}, {'name': 'Lihi Godny, BSc', 'role': 'CONTACT', 'email': 'lihigodny@gmail.com', 'phone': '+97237525015'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rabin Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Leona M. and Harry B. Helmsley Charitable Trust', 'class': 'OTHER'}, {'name': 'Tel Aviv University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of The Gastroenterology Division', 'investigatorFullName': 'IRIS DOTAN', 'investigatorAffiliation': 'Rabin Medical Center'}}}}