The Impact of Probiotic Bacteria on the Efficacy of Anti-retroviral Therapy and Recurrence of Bacterial Vaginosis
Sponsor
Lawson Health Research Institute (Other)
Overall Status
Completed
CT.gov ID
NCT01258556
Collaborator
(none)
150
1
2
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2/Phase 3 |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
150 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Study Start Date
:
Jun 1, 2010
Actual Primary Completion Date
:
Jul 1, 2010
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Probiotic yogurt
|
Dietary Supplement: Yogurt supplemented with L. rhamnosus fiti
200 ml of L. rhamnosus fiti at 10*9 cfu/ml daily for 30 days.
|
| Placebo Comparator: Placebo yogurt.
|
Dietary Supplement: Yogurt not supplemented with a probiotic strain.
200 ml yoghurt without L. rhamnosus fiti daily for 30 days.
|
Outcome Measures
Primary Outcome Measures
- Vaginal microbiota of HIV patients. [30 days]
Secondary Outcome Measures
- Bacterial vaginosis. [30 days]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 80 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sekou-Toure Regional Hospital | Mwanza | Tanzania |
Sponsors and Collaborators
- Lawson Health Research Institute
Investigators
- Principal Investigator: Nicodemus Butamanya, MD, Sekou-Toure Regional Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT01258556
Other Study ID Numbers:
- 919
First Posted:
Dec 13, 2010
Last Update Posted:
Dec 13, 2010
Last Verified:
Dec 1, 2010