Ignite Creation Date:
2025-12-24 @ 10:29 PM
Ignite Modification Date:
2026-02-20 @ 11:49 PM
Study NCT ID:
NCT00561535
Status:
COMPLETED
Last Update Posted:
2011-01-27
First Post:
2007-11-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of a Probiotic, Lactobacillus FARCIMINIS, in Diarrhea Predominant IBS Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D043183', 'term': 'Irritable Bowel Syndrome'}, {'id': 'D003967', 'term': 'Diarrhea'}], 'ancestors': [{'id': 'D003109', 'term': 'Colonic Diseases, Functional'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-01', 'completionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-01-26', 'studyFirstSubmitDate': '2007-11-20', 'studyFirstSubmitQcDate': '2007-11-20', 'lastUpdatePostDateStruct': {'date': '2011-01-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-11-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Overall subject's assessment", 'timeFrame': '4 weeks'}], 'secondaryOutcomes': [{'measure': 'Decrease in abdominal pain, stool form and consistency, modifications in intestinal permeability, modification in fecal serine protease activity, modifications in interleukin seric concentrations', 'timeFrame': '4 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['IBS', 'Diarrhea', 'Rome III'], 'conditions': ['Irritable Bowel Syndrome']}, 'referencesModule': {'references': [{'pmid': '18848833', 'type': 'BACKGROUND', 'citation': 'Camilleri M, Chang L. Challenges to the therapeutic pipeline for irritable bowel syndrome: end points and regulatory hurdles. Gastroenterology. 2008 Dec;135(6):1877-91. doi: 10.1053/j.gastro.2008.09.005. Epub 2008 Oct 9.'}]}, 'descriptionModule': {'briefSummary': 'Probiotics may improve symptoms in IBS patients. The aim of this study is to test the efficacy of Lactobacillus FARCIMINIS in diarrhea predominant IBS patients according to Rome III criteria.', 'detailedDescription': 'The aim of this study is to test the efficacy of Lactobacillus FARCIMINIS in diarrhea predominant IBS patients according to Rome III criteria.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diarrhea predominant IBS\n* Less than 5-year duration\n* Pain intensity between 2 and 7 on VAS\n\nExclusion Criteria:\n\n* Celiac disease\n* Antibiotic treatment within the 1-month period preceding inclusion\n* Digestive organic disease\n* Any severe non digestive organic disease'}, 'identificationModule': {'nctId': 'NCT00561535', 'briefTitle': 'Effect of a Probiotic, Lactobacillus FARCIMINIS, in Diarrhea Predominant IBS Patients', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Effect of a Probiotic, Lactobacillus FARCIMINIS, in Diarrhea Predominant IBS', 'orgStudyIdInfo': {'id': 'AEFD 2007-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'description': 'Lactobacillus FARCIMINIS', 'interventionNames': ['Dietary Supplement: Lactobacillus FARCIMINIS']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'B', 'description': 'Placebo', 'interventionNames': ['Dietary Supplement: placebo (starch)']}], 'interventions': [{'name': 'Lactobacillus FARCIMINIS', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['10.10 UFC of lactobacillus FARCIMINIS'], 'description': '10.10 UFC of lactobacillus FARCIMINIS', 'armGroupLabels': ['A']}, {'name': 'placebo (starch)', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Once daily'], 'description': 'Once daily', 'armGroupLabels': ['B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92700', 'city': 'Colombes', 'state': 'Île-de-France Region', 'country': 'France', 'facility': 'Hopital Louis Mourier, GI Unit', 'geoPoint': {'lat': 48.91882, 'lon': 2.25404}}], 'overallOfficials': [{'name': 'Benoit Coffin, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}, {'name': 'Yoram Bouhnik, Prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'collaborators': [{'name': "Association pour l'Etude des Fonctions Digestives", 'class': 'UNKNOWN'}], 'responsibleParty': {'oldNameTitle': 'COFFIN', 'oldOrganization': "Association pour l'Etude des Fonctions Digestives"}}}}