Ignite Creation Date:
2025-12-24 @ 1:05 PM
Ignite Modification Date:
2025-12-29 @ 7:20 AM
Study NCT ID:
NCT06392061
Status:
RECRUITING
Last Update Posted:
2024-04-30
First Post:
2024-04-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Probiotic Administration on Patients With Inflammatory Bowel Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D000073923', 'term': 'Food Intolerance'}, {'id': 'D003093', 'term': 'Colitis, Ulcerative'}, {'id': 'D003424', 'term': 'Crohn Disease'}], 'ancestors': [{'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D003092', 'term': 'Colitis'}, {'id': 'D003108', 'term': 'Colonic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-26', 'studyFirstSubmitDate': '2024-04-18', 'studyFirstSubmitQcDate': '2024-04-26', 'lastUpdatePostDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disease course', 'timeFrame': '8 weeks', 'description': 'Change in frequency of flares over 2 months'}, {'measure': 'Disease course', 'timeFrame': '8 weeks', 'description': 'Change in hospitalizations rates over 2 months'}, {'measure': 'Nutrition Status', 'timeFrame': '8 weeks', 'description': 'Change in macro- and micronutrient intake by administrating 24 h recall to be analysed by Nutritionist Pro Software'}], 'secondaryOutcomes': [{'measure': 'Quality of Life Status', 'timeFrame': '8 weeks', 'description': 'Change in quality-of-life score as per WHOQOL Bref'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Inflammatory Bowel Diseases', 'Quality of Life', 'Food Intolerance', 'Flare Up', 'Ulcerative Colitis', 'Crohn Disease']}, 'descriptionModule': {'briefSummary': "The study is a single-center, randomized, single-blinded, controlled trial conducted at ZHUMC's endoscopy unit. It aims to assess the short-term effects of probiotic administration on disease course, quality of life, and nutritional status among patients diagnosed with inflammatory bowel disease (IBD), specifically ulcerative colitis (UC) and Crohn's disease (CD).\n\nPatients with UC and CD will be recruited from the endoscopy unit's outpatients and divided into two groups: a control group and an intervention probiotic group. The intervention probiotic group will receive the probiotic intervention for 2 months. During the study period, two visits will be scheduled for all patients.\n\nAt each visit, medical and nutrition surveys will be filled out, and body composition measurements will be conducted. These assessments will help evaluate the impact of probiotic administration on the participants' disease progression, their quality of life, and their nutritional status.\n\nOverall, the study aims to provide insights into the potential benefits of probiotic supplementation in managing IBD and improving the well-being of patients with these conditions."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Lebanese outpatients with histological diagnosis of Crohn's disease or Ulcerative Colitis from at least 6 months prior to the trial.\n* have stable inactive disease.\n* have not used any probiotics within the two months before the investigation.\n\nExclusion Criteria:\n\n* pregnant or lactating women\n* patients who use probiotics within the study period."}, 'identificationModule': {'nctId': 'NCT06392061', 'briefTitle': 'Effect of Probiotic Administration on Patients With Inflammatory Bowel Disease', 'organization': {'class': 'OTHER', 'fullName': 'Lebanese University'}, 'officialTitle': 'Assessment of Medical and Nutritional Status Post-Probiotic Intake in Patients Diagnosed With Inflammatory Bowel Disease: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'LebaneseUni'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Probiotic', 'description': 'Contains 4 strains of naturally-occurring bacteria including: Lactobacillus acidophilus, LA-5®, Bifidobacterium animalis, BB-12®, Streptococcus thermophiles, STY-31 and Lactobacillus delbrueckii subsp. Bulgaricus LBY-27 in concentration of 4.5 milliards CFU/capsule.', 'interventionNames': ['Dietary Supplement: Trilac']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'The patients will be asked to continue their usual lifestyle without change in their usual medication and nutritional intake.'}], 'interventions': [{'name': 'Trilac', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Trilac® is a dietary supplement developed by Surveal Pharma to support digestive health and overall well-being. This probiotic contains 4 strains of naturally-occurring bacteria including: Lactobacillus acidophilus, LA-5®, Bifidobacterium animalis, BB-12®, Streptococcus thermophiles, STY-31 and Lactobacillus delbrueckii subsp. Bulgaricus LBY-27 in concentration of 4.5 milliards CFU/capsule. Patients in the probiotic group will be instructed to take one tablet per day for a period of 8 weeks.', 'armGroupLabels': ['Probiotic']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beirut', 'status': 'RECRUITING', 'country': 'Lebanon', 'contacts': [{'name': 'zahra Sadek, PhD', 'role': 'CONTACT', 'email': 'zahrasadek81@hotmail.com', 'phone': '+9613947985'}], 'facility': 'zahra Sadek', 'geoPoint': {'lat': 33.89332, 'lon': 35.50157}}], 'centralContacts': [{'name': 'zahra Sadek, PhD', 'role': 'CONTACT', 'email': 'zahrasadek81@hotmail.com', 'phone': '+9613947985'}, {'name': 'Nadeen Zayour', 'role': 'CONTACT', 'email': 'nadeen.zayour@zhumc.org.lb', 'phone': '+96170039975'}], 'overallOfficials': [{'name': 'Mahmoud Hallal', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Al Zahraa Hospital University Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lebanese University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Zahra SADEK', 'investigatorAffiliation': 'Lebanese University'}}}}