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CompletedNCT01258556Updated Dec 13, 2010

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

A Phase 2/3 interventional study of Yogurt supplemented with L. rhamnosus fiti and Yogurt not supplemented with a probiotic strain. in Bacterial Vaginosis, sponsored by London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's. Completed at 1 site in Tanzania. Open to female participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2010-12-13.

Sponsored by London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Bacterial Vaginosis
03

In context

Vaginosis, Bacterial

220 studies on the registry are indexed under Vaginosis, Bacterial; 36 are open to participants now.

This study's planned enrollment of 150 is above the median of 100 across 187 interventional studies indexed under Vaginosis, Bacterial.

Browse Vaginosis, Bacterial studies →

Lead sponsor

London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's is the lead sponsor of 352 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Confirmed HIV infection;
  • Being treated with anti-retroviral medication for > 6 months.

Exclusion criteria

Exclusion criteria:

  • Pregnancy;
  • Hypersensitive to fermented milk;
  • Intolerant for lactose;
  • Complaints of bacterial vaginosis requiring treatment
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
150 participants (estimated)

Study arms

  • Experimental
    Probiotic yogurt

    Dietary Supplement: Yogurt supplemented with L. rhamnosus fiti

  • Placebo comparator
    Placebo yogurt.

    Dietary Supplement: Yogurt not supplemented with a probiotic strain.

Interventions

  • Dietary supplementYogurt supplemented with L. rhamnosus fiti

    200 ml of L. rhamnosus fiti at 10\*9 cfu/ml daily for 30 days.

  • Dietary supplementYogurt not supplemented with a probiotic strain.

    200 ml yoghurt without L. rhamnosus fiti daily for 30 days.

06

What researchers measure

Primary outcomes

  1. Vaginal microbiota of HIV patients.

    Time frame: 30 days

Secondary outcomes

  1. Bacterial vaginosis.

    Time frame: 30 days

07

Study locations

1 site
  • Sekou-Toure Regional Hospital
    Mwanza, Tanzania
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 13, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01258556
Lead sponsor
London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's
First posted
Dec 13, 2010
Start date
Jun 2010
Primary completion
Jul 2010
Last update
Dec 13, 2010

Study contacts

Nicodemus Butamanya, MD
principal investigator · Sekou-Toure Regional Hospital
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2010. You cannot join it, but the record below documents what was studied.

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