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OpenTrials
Completed

NCT Number: NCT01258556

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

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.

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Key information

Conditions

Bacterial Vaginosis Bacterial Infections Bacterial Infections and Mycoses Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infections Urogenital Diseases Vaginal Diseases Vaginitis Vaginosis, Bacterial

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Sekou-Toure Regional Hospital

Mwanza, Tanzania

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Yogurt supplemented with L. rhamnosus fiti

Dietary Supplement

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

Yogurt not supplemented with a probiotic strain.

Dietary Supplement

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

Primary outcomes

  1. Vaginal microbiota of HIV patients.

    Time frame: 30 days

Secondary outcomes

  1. Bacterial vaginosis.

    Time frame: 30 days

Sponsors and collaborators

Lead sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Other

Registry information

Important dates

Study start
2010
Primary completion
2010
First posted
Dec 13, 2010
Registry last updated
Dec 13, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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