CompletedInterventionalNot ApplicableUpdated Nov 19, 2021
The Impact of Probiotic Bacteria on the Efficacy of Anti-retroviral Therapy and Recurrence of Bacterial Vaginosis | NCT01258556 | Trialant
CompletedInterventionalPhase 2Phase 3Updated Dec 13, 2010
The Impact of Probiotic Bacteria on the Efficacy of Anti-retroviral Therapy and Recurrence of Bacterial Vaginosis
ClinicalTrials.gov ID
NCT01258556
Lead Sponsor
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sOTHER
Overall Status
Completed
Study Type
Interventional
Phase
Phase 2Phase 3
Enrollment
150Estimated
Last Update Posted
Dec 13, 2010Estimated
Start Date
Jun 2010
Primary Completion Date
Jul 2010Actual
Brief Summary
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.
Bacterial Vaginosis
Yogurt supplemented with L. rhamnosus fiti
Yogurt not supplemented with a probiotic strain.
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
Confirmed HIV infection;
Being treated with anti-retroviral medication for > 6 months.
Exclusion criteria:
Pregnancy;
Hypersensitive to fermented milk;
Intolerant for lactose;
Complaints of bacterial vaginosis requiring treatment
Primary Purpose
Treatment
Allocation
Randomized
Interventional Model
Parallel Assignment
Masking
Quadruple
No central contacts
There are no central contacts for this study.
Sekou-Toure Regional Hospital
Mwanza, Tanzania
Lead Sponsor
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sOTHER