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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:
ClinicalTrials.gov Identifier:
NCT01258556
First Posted: December 13, 2010
Last Update Posted: December 13, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Lawson Health Research Institute
  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: Quadruple (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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Gregor Reid, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT01258556     History of Changes
Other Study ID Numbers: 919
First Submitted: December 10, 2010
First Posted: December 13, 2010
Last Update Posted: December 13, 2010
Last Verified: December 2010

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