Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2026-02-22 @ 10:28 AM
Study NCT ID:
NCT00793494
Status:
TERMINATED
Last Update Posted:
2016-04-13
First Post:
2008-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Probaclac in Irritable Bowel Syndrome in Children Aged 8 to 18 Years
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D043183', 'term': 'Irritable Bowel Syndrome'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'whyStopped': 'Recruitment impossible', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-12', 'studyFirstSubmitDate': '2008-11-17', 'studyFirstSubmitQcDate': '2008-11-18', 'lastUpdatePostDateStruct': {'date': '2016-04-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-11-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Subjective assessment of improvement of symptoms', 'timeFrame': '4 weeks'}], 'secondaryOutcomes': [{'measure': 'Change in severity of symptoms (likert scale)', 'timeFrame': '4 weeks'}, {'measure': 'Presence and intensity of pain episodes', 'timeFrame': '4 weeks'}, {'measure': 'Presence or absence of urgency, incomplete evacuation, gas', 'timeFrame': '4 weeks'}, {'measure': 'Number and consistance of the stools', 'timeFrame': '4 weeks'}, {'measure': 'School and social absenteism', 'timeFrame': '4 weeks'}, {'measure': 'Quality of Life', 'timeFrame': '4 weeks'}, {'measure': 'Adverse Events', 'timeFrame': '2 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Irritable bowel syndrome', 'Children', 'Pediatrics', 'Probiotics'], 'conditions': ['Irritable Bowel Syndrome']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.christophefaure.org', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to determine the efficacy of the administration of Bifidobacterium bifidum R0071, Bifidobacterium longum R0175, Lactobacillus helveticus R0052, Lactobacillus Delb. SSP bulgaricus R9001, Lactobacillus rhamnosus R0011, Lactococcus Lactis SSP. lactis R1058 et Streptococcus thermophilus (Probaclac™) given twice a day for 4 weeks on digestive symptoms evaluated subjectively in children aged 8 to 18 years with irritable bowel syndrome versus placebo.\n\nThis study is a double-blind randomized controlled study. 84 children will included. After inclusion, a 15-day period of observation precedes the randomization at Day 0. Patients receive Probaclac or placebo for 4 weeks. At the end of the treatment period, patients are followed for a 2-week period of follow-up.\n\n4 visits and 4 phone calls are planned during the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '8 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Children 8 to 18 years\n* Irritable bowel syndrome according to Rome III criteria\n\nExclusion Criteria:\n\n* Not able to collaborate\n* Known Digestive malformation\n* History of digestive surgery (except hernia repair and appendectomy)\n* History of known digestive disease (Crohn's, ulcerative colitis, esophagitis, peptic ulcer, celiac disease)\n* Symptoms suggestive of organic disease (such as rectal bleeding, weight loss\n* History of chronic extra-digestive disease\n* Acute gastroenteritis in th e4 weeks prior to inclusion\n* Central catheter, artificial cardiac valve, endocardiac prothesis\n* Current Antidepressant treatment\n* Patients taking a treatment for irritable bowel syndrome unable to cease their current treatment\n* Patient taking regularly probiotics and natural products"}, 'identificationModule': {'nctId': 'NCT00793494', 'acronym': 'POPSII', 'briefTitle': 'Efficacy of Probaclac in Irritable Bowel Syndrome in Children Aged 8 to 18 Years', 'organization': {'class': 'OTHER', 'fullName': "St. Justine's Hospital"}, 'officialTitle': 'Randomized Controlled Trial of Probaclac Versus Placebo in Children Aged 8 to 18 Years With Irritable Bowel Syndrome', 'orgStudyIdInfo': {'id': 'Probaclac-HSJ'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Probaclac', 'description': 'Administration of Bifidobacterium bifidum R0071, Bifidobacterium longum R0175, Lactobacillus helveticus R0052, Lactobacillus Delb. SSP bulgaricus R9001, Lactobacillus rhamnosus R0011, Lactococcus Lactis SSP. lactis R1058 et Streptococcus thermophilus (Probaclac™) b.i.d.', 'interventionNames': ['Other: Probaclac']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Probaclac', 'type': 'OTHER', 'description': 'Bifidobacterium bifidum R0071, Bifidobacterium longum R0175, Lactobacillus helveticus R0052, Lactobacillus Delb. SSP bulgaricus R9001, Lactobacillus rhamnosus R0011, Lactococcus Lactis SSP. lactis R1058 et Streptococcus thermophilus (Probaclac™)', 'armGroupLabels': ['Probaclac']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo composition matodextrin, gelatin, ascorbic acid, soya', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H3T1C5', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Hôpital Sainte Justine', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Christophe M Faure, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ste-Justine Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "St. Justine's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'Nicar Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Christophe Faure', 'investigatorAffiliation': "St. Justine's Hospital"}}}}