Ignite Creation Date:
2025-12-24 @ 11:17 PM
Ignite Modification Date:
2026-02-22 @ 4:35 AM
Study NCT ID:
NCT01258556
Status:
COMPLETED
Last Update Posted:
2010-12-13
First Post:
2010-12-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Impact of Probiotic Bacteria on the Efficacy of Anti-retroviral Therapy and Recurrence of Bacterial Vaginosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016585', 'term': 'Vaginosis, Bacterial'}], 'ancestors': [{'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014627', 'term': 'Vaginitis'}, {'id': 'D014623', 'term': 'Vaginal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-12', 'lastUpdateSubmitDate': '2010-12-10', 'studyFirstSubmitDate': '2010-12-10', 'studyFirstSubmitQcDate': '2010-12-10', 'lastUpdatePostDateStruct': {'date': '2010-12-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-12-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Vaginal microbiota of HIV patients.', 'timeFrame': '30 days'}], 'secondaryOutcomes': [{'measure': 'Bacterial vaginosis.', 'timeFrame': '30 days'}]}, 'conditionsModule': {'conditions': ['Bacterial Vaginosis']}, 'descriptionModule': {'briefSummary': 'Purpose of the proposed research is to determine the impact of probiotic yogurt supplemented with Lactobacillus rhamnosus (Fiti) compared to regular yogurt on the well-being of women living with HIV.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Confirmed HIV infection;\n* Being treated with anti-retroviral medication for \\> 6 months.\n\nExclusion criteria:\n\n* Pregnancy;\n* Hypersensitive to fermented milk;\n* Intolerant for lactose;\n* Complaints of bacterial vaginosis requiring treatment'}, 'identificationModule': {'nctId': 'NCT01258556', 'briefTitle': 'The Impact of Probiotic Bacteria on the Efficacy of Anti-retroviral Therapy and Recurrence of Bacterial Vaginosis', 'organization': {'class': 'OTHER', 'fullName': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's"}, 'orgStudyIdInfo': {'id': '919'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Probiotic yogurt', 'interventionNames': ['Dietary Supplement: Yogurt supplemented with L. rhamnosus fiti']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo yogurt.', 'interventionNames': ['Dietary Supplement: Yogurt not supplemented with a probiotic strain.']}], 'interventions': [{'name': 'Yogurt supplemented with L. rhamnosus fiti', 'type': 'DIETARY_SUPPLEMENT', 'description': '200 ml of L. rhamnosus fiti at 10\\*9 cfu/ml daily for 30 days.', 'armGroupLabels': ['Probiotic yogurt']}, {'name': 'Yogurt not supplemented with a probiotic strain.', 'type': 'DIETARY_SUPPLEMENT', 'description': '200 ml yoghurt without L. rhamnosus fiti daily for 30 days.', 'armGroupLabels': ['Placebo yogurt.']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Mwanza', 'country': 'Tanzania', 'facility': 'Sekou-Toure Regional Hospital', 'geoPoint': {'lat': -2.51667, 'lon': 32.9}}], 'overallOfficials': [{'name': 'Nicodemus Butamanya, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sekou-Toure Regional Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's", 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Gregor Reid', 'oldOrganization': 'Lawson Health Research Institute'}}}}