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

Bacterial Vaginosis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01258556
• Other study ID #: 919
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: December 10, 2010
• Last updated: December 10, 2010
• Start date: June 2010

Study information

• Verified date: December 2010
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: National Institute for Medical Research: Tanzania
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bacterial Vaginosis
• Vaginal Diseases
• Vaginosis, Bacterial

Intervention

Dietary Supplement:
• Yogurt supplemented with L. rhamnosus fiti
200 ml of L. rhamnosus fiti at 10*9 cfu/ml daily for 30 days.
• Yogurt not supplemented with a probiotic strain.
200 ml yoghurt without L. rhamnosus fiti daily for 30 days.

Locations

Country	Name	City	State
Tanzania	Sekou-Toure Regional Hospital	Mwanza

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Tanzania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vaginal microbiota of HIV patients.		30 days	No
Secondary	Bacterial vaginosis.		30 days	No