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

Lawson Health Research Institute

Status and phase: Completed; Phase 3; Phase 2

Conditions: Bacterial Vaginosis

Treatments: Dietary Supplement: Yogurt not supplemented with a probiotic strain.; Dietary Supplement: Yogurt supplemented with L. rhamnosus fiti

Study type: Interventional

Funder types: Other

Identifiers

NCT01258556

919

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

150 participants in 2 patient groups, including a placebo group

Probiotic yogurt

Experimental group

Treatment:

Dietary Supplement: Yogurt supplemented with L. rhamnosus fiti

Placebo yogurt.

Placebo Comparator group

Treatment:

Dietary Supplement: Yogurt not supplemented with a probiotic strain.