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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.
Sponsor:
Information provided by:
Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT01258556
First received: December 10, 2010
Last updated: NA
Last verified: December 2010
History: No changes posted
  Purpose

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 (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • Vaginal microbiota of HIV patients. [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Bacterial vaginosis. [ Time Frame: 30 days ] [ Designated as safety issue: No ]

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01258556

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

No publications provided

Responsible Party: Gregor Reid, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT01258556     History of Changes
Other Study ID Numbers: 919
Study First Received: December 10, 2010
Last Updated: December 10, 2010
Health Authority: National Institute for Medical Research: Tanzania

Additional relevant MeSH terms:
Vaginosis, Bacterial
Bacterial Infections
Vaginitis
Vaginal Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on May 19, 2013