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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 15, 2014