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

December 10, 2010
December 10, 2010
June 2010
July 2010   (final data collection date for primary outcome measure)
Vaginal microbiota of HIV patients. [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Bacterial vaginosis. [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
The Impact of Probiotic Bacteria on the Efficacy of Anti-retroviral Therapy and Recurrence of Bacterial Vaginosis
Not Provided

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.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Bacterial Vaginosis
  • Dietary Supplement: Yogurt supplemented with L. rhamnosus fiti
    200 ml of L. rhamnosus fiti at 10*9 cfu/ml daily for 30 days.
  • Dietary Supplement: Yogurt not supplemented with a probiotic strain.
    200 ml yoghurt without L. rhamnosus fiti daily for 30 days.
  • Experimental: Probiotic yogurt
    Intervention: Dietary Supplement: Yogurt supplemented with L. rhamnosus fiti
  • Placebo Comparator: Placebo yogurt.
    Intervention: Dietary Supplement: Yogurt not supplemented with a probiotic strain.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
Not Provided
July 2010   (final data collection date for primary outcome measure)

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
Female
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Tanzania
 
NCT01258556
919
Not Provided
Gregor Reid, Lawson Health Research Institute
Lawson Health Research Institute
Not Provided
Principal Investigator: Nicodemus Butamanya, MD Sekou-Toure Regional Hospital
Lawson Health Research Institute
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP