The Impact of Probiotic Bacteria on the Efficacy of Anti-retroviral Therapy and Recurrence of Bacterial Vaginosis

Phase 2

Completed

• Conditions: Bacterial Vaginosis
• Interventions: Dietary Supplement: Yogurt supplemented with L. rhamnosus fiti; Dietary Supplement: Yogurt not supplemented with a probiotic strain.

• Registration Number: NCT01258556
• Lead Sponsor: Lawson Health Research Institute

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06
• Primary Completion: 2010-07
• Status Verified: 2010-12
• Study First Submitted: 2010-12-10
• Study First Submitted QC: 2010-12-10
• Last Update Submitted: 2010-12-10
• Study First Posted: 2010-12-13
• Last Update Posted: 2010-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 150

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Probiotic yogurt	Yogurt supplemented with L. rhamnosus fiti	-
Placebo yogurt.	Yogurt not supplemented with a probiotic strain.	-

Primary Outcome Measures

Name	Time	Method
Vaginal microbiota of HIV patients.	30 days

Secondary Outcome Measures

Name	Time	Method
Bacterial vaginosis.	30 days

Trial Locations

Locations (1)

Sekou-Toure Regional Hospital; 🇹🇿 Mwanza, Tanzania