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

NCT ID: NCT01258556

Last Updated: 2010-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Brief Summary

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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

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Conditions

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Bacterial Vaginosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Probiotic yogurt

Group Type EXPERIMENTAL

Yogurt supplemented with L. rhamnosus fiti

Intervention Type DIETARY_SUPPLEMENT

200 ml of L. rhamnosus fiti at 10\*9 cfu/ml daily for 30 days.

Placebo yogurt.

Group Type PLACEBO_COMPARATOR

Yogurt not supplemented with a probiotic strain.

Intervention Type DIETARY_SUPPLEMENT

200 ml yoghurt without L. rhamnosus fiti daily for 30 days.

Interventions

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Yogurt supplemented with L. rhamnosus fiti

200 ml of L. rhamnosus fiti at 10\*9 cfu/ml daily for 30 days.

Intervention Type DIETARY_SUPPLEMENT

Yogurt not supplemented with a probiotic strain.

200 ml yoghurt without L. rhamnosus fiti daily for 30 days.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

OTHER

Sponsor Role lead

Responsible Party

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Lawson Health Research Institute

Principal Investigators

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Nicodemus Butamanya, MD

Role: PRINCIPAL_INVESTIGATOR

Sekou-Toure Regional Hospital

Locations

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Sekou-Toure Regional Hospital

Mwanza, , Tanzania

Site Status

Countries

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Tanzania

Other Identifiers

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919

Identifier Type: -

Identifier Source: org_study_id