Ignite Creation Date:
2025-12-24 @ 2:56 PM
Ignite Modification Date:
2025-12-26 @ 8:13 AM
Study NCT ID:
NCT01529359
Status:
COMPLETED
Last Update Posted:
2021-04-20
First Post:
2011-10-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Irritable Bowel Syndrome and Lactibiane Tolerance
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019936', 'term': 'Probiotics'}], 'ancestors': [{'id': 'D019587', 'term': 'Dietary Supplements'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 123}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-03-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2013-02-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-19', 'studyFirstSubmitDate': '2011-10-10', 'studyFirstSubmitQcDate': '2012-02-06', 'lastUpdatePostDateStruct': {'date': '2021-04-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-02-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-02-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Severity of bowel symptoms according to the Francis Score', 'timeFrame': 'After 6 weeks of complementation', 'description': 'The severity of bowel symptoms is evaluated with a quality of life questionnaire, the Francis Score before and after 6 weeks of complementation in placebo and verum groups.'}], 'secondaryOutcomes': [{'measure': 'Quality of life', 'timeFrame': 'after 6 weeks of complementation', 'description': 'Effect of the intervention on transit and abdominal pain'}, {'measure': 'Severity of Anxiety/Depression', 'timeFrame': 'after 6 weeks of complementation', 'description': 'The level of anxiety/depression will be measured with the HAD scale'}, {'measure': 'Impact of the complementation on fatigue', 'timeFrame': 'after 6 weeks of complementation', 'description': 'The level of fatigue will be measured with the score to the fatigue Impact Scale (FIS)'}, {'measure': 'Impact of the intervention on immunological parameters in stools', 'timeFrame': 'after 6 weeks of complementation', 'description': 'The effects of the intervention on immunological parameters in stools will be evaluated via the levels of beta-defensine 2 and sérine protease activities'}, {'measure': 'Impact of the intervention on immunological parameters in blood', 'timeFrame': 'after 6 weeks of complementation', 'description': 'The impact of the intervention on immunological parameters in blood will be measured with levels of endotoxines, ultrasensitive protein C Reactive and cytokines'}, {'measure': 'Severity of bowel symptoms according to the Francis Score', 'timeFrame': 'after 2 weeks of wash-out', 'description': 'The severity of bowel symptoms is evaluated with the Francis Score before 6 weeks of complementation and after 2 weeks of wash-out in placebo and verum groups'}, {'measure': 'Quality of life', 'timeFrame': 'after 2 weeks of wash-out', 'description': 'Effect of the intervention on transit and abdominal pain'}, {'measure': 'severity of the anxiety/depression', 'timeFrame': 'after 2 weeks of wash-out', 'description': 'The level of anxiety/depression will be measured with the HAD scale'}, {'measure': 'Impact of the complementation on fatigue', 'timeFrame': 'After 2 weeks of wash out', 'description': 'The level of fatigue will be measured with the score to the fatigue Impact Scale (FIS)'}, {'measure': 'Impact of the intervention on immunological parameters in stools', 'timeFrame': 'after 2 weeks of wash out', 'description': 'The effects of the intervention on immunological parameters in stools will be avaluated via the levels of beta-defensine 2 and sérine protease activities'}, {'measure': 'Impact of the intervention on immunological parameters in blood', 'timeFrame': 'after 2 weeks of wash-out', 'description': 'The impact of the intervention on immunological parameters in blood will be measured with levels of endotoxines, ultrasensitive protein C Reactive and cytokines'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Irritable Bowel Syndrome', 'Probiotics'], 'conditions': ['Irritable Bowel Syndrome']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effects of a probiotic combination (Lactibiane Tolerance) on the severity of symptoms in patients with irritable bowel syndrome (IBS).', 'detailedDescription': 'The primary purpose of this study is to evaluate the effects of a probiotic combination (Lactibiane Tolerance) on the severity of symptoms in patients with irritable bowel syndrome (IBS).\n\nThe secondary purposes are to evaluate the effects of the intervention on:\n\n* quality of life\n* severity of fatigue, anxiety and depression\n* levels of inflammatory markers in blood and tools'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Irritable bowel syndrome according to the Rome II criteria\n* 150\\< Francis Score \\< 300\n* HAD score inferior or egal to 25\n\nExclusion Criteria:\n\n* History of hypersensitivity to one of the composant of the product\n* Use of probiotics or antibiotics last four weeks\n* use of prohibited drugs\n* bowel preparation for morphological examination last month\n* pregnancy or lactation\n* immundepressed or co-existing other serious illness or evolutive'}, 'identificationModule': {'nctId': 'NCT01529359', 'briefTitle': 'Irritable Bowel Syndrome and Lactibiane Tolerance', 'organization': {'class': 'INDUSTRY', 'fullName': 'Larena SAS'}, 'officialTitle': 'Effect of Lactibiane Tolerance on Symptoms Severity of Irritable Bowel Syndrome', 'orgStudyIdInfo': {'id': 'PiLeJe-LactiTol-0210'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Probiotics Excipients', 'interventionNames': ['Dietary Supplement: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Lactibiane Tolerance', 'description': 'Probiotics combination', 'interventionNames': ['Dietary Supplement: Lactibiane Tolerance']}], 'interventions': [{'name': 'Lactibiane Tolerance', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Probiotic'], 'description': 'Probiotics combination 2 gelules per days during 6 weeks', 'armGroupLabels': ['Lactibiane Tolerance']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Placebo 2 gelules per days for 6 weeks', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06200', 'city': 'Nice', 'state': 'Alpes Maritimes', 'country': 'France', 'facility': "Chu L'Archet 2", 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}], 'overallOfficials': [{'name': 'Piche Thierry, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'PiLeJe', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}