Back to resultsThe Impact of Probiotic Bacteria on the Efficacy of Anti-retroviral Therapy and Recurrence of Bacterial Vaginosis
Primary Purpose
Bacterial Vaginosis
Status
Completed
Phase
Phase 2
Locations
Tanzania
Study Type
Interventional
Intervention
Yogurt supplemented with L. rhamnosus fiti
Yogurt not supplemented with a probiotic strain.
Sponsored by
About this trial
This is an interventional treatment trial for Bacterial Vaginosis
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
Sites / Locations
- Sekou-Toure Regional Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Probiotic yogurt
Placebo yogurt.
Arm Description
Outcomes
Primary Outcome Measures
Vaginal microbiota of HIV patients.
Secondary Outcome Measures
Bacterial vaginosis.
Full Information
NCT ID
NCT01258556
First Posted
December 10, 2010
Last Updated
December 10, 2010
Sponsor
Lawson Health Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT01258556
Brief Title
The Impact of Probiotic Bacteria on the Efficacy of Anti-retroviral Therapy and Recurrence of Bacterial Vaginosis
Study Type
Interventional
2. Study Status
Record Verification Date
December 2010
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Lawson Health Research Institute
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacterial Vaginosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Probiotic yogurt
Arm Type
Experimental
Arm Title
Placebo yogurt.
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Yogurt supplemented with L. rhamnosus fiti
Intervention Description
200 ml of L. rhamnosus fiti at 10*9 cfu/ml daily for 30 days.
Intervention Type
Dietary Supplement
Intervention Name(s)
Yogurt not supplemented with a probiotic strain.
Intervention Description
200 ml yoghurt without L. rhamnosus fiti daily for 30 days.
Primary Outcome Measure Information:
Title
Vaginal microbiota of HIV patients.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Bacterial vaginosis.
Time Frame
30 days
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicodemus Butamanya, MD
Organizational Affiliation
Sekou-Toure Regional Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sekou-Toure Regional Hospital
City
Mwanza
Country
Tanzania
12. IPD Sharing Statement
Learn more about this trial
The Impact of Probiotic Bacteria on the Efficacy of Anti-retroviral Therapy and Recurrence of Bacterial Vaginosis
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