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

This study has been completed.
Information provided by:
Lawson Health Research Institute Identifier:
First received: December 10, 2010
Last updated: NA
Last verified: December 2010
History: No changes posted
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 Intervention Phase
Bacterial Vaginosis
Dietary Supplement: Yogurt supplemented with L. rhamnosus fiti
Dietary Supplement: Yogurt not supplemented with a probiotic strain.
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • Vaginal microbiota of HIV patients. [ Time Frame: 30 days ]

Secondary Outcome Measures:
  • Bacterial vaginosis. [ Time Frame: 30 days ]

Estimated Enrollment: 150
Study Start Date: June 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
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
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Please refer to this study by its identifier: NCT01258556

Sekou-Toure Regional Hospital
Mwanza, Tanzania
Sponsors and Collaborators
Lawson Health Research Institute
Principal Investigator: Nicodemus Butamanya, MD Sekou-Toure Regional Hospital
  More Information

Responsible Party: Gregor Reid, Lawson Health Research Institute Identifier: NCT01258556     History of Changes
Other Study ID Numbers: 919
Study First Received: December 10, 2010
Last Updated: December 10, 2010

Additional relevant MeSH terms:
Vaginal Diseases
Vaginosis, Bacterial
Genital Diseases, Female
Bacterial Infections
Vaginitis processed this record on May 25, 2017