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

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ClinicalTrials.gov Identifier: NCT01258556
Recruitment Status : Completed
First Posted : December 13, 2010
Last Update Posted : December 13, 2010
Sponsor:
Information provided by:
Lawson Health Research Institute

Brief Summary:
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 or disease Intervention/treatment 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  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : June 2010
Actual Primary Completion Date : July 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaginal Diseases
U.S. FDA Resources

Arm Intervention/treatment
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.



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

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


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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

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

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

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