The Effect of Probiotics on the Immune Status, Diarrhea and Bacterial Vaginosis Cure Rate Among HIV Patients

Phase 2

• Conditions: HIV Infections; Diarrhea; Bacterial Vaginosis
• Interventions: Dietary Supplement: Lactobacillus rhamnosus GR-1 + Lactobacillus reuteri RC-14; Dietary Supplement: Placebo; Drug: Metronidazole

• Registration Number: NCT00536848
• Lead Sponsor: National Institute for Medical Research, Tanzania

Brief Summary

The purpose of this study is to asses whether probiotics Lactobacillus rhamnosus (GR-1) and reuteri (RC-14) are able to prevent diarrhea, delay the decline of the immune system and prevent and/or cure bacterial vaginosis among HIV patients.

Detailed Description

Background: Two third of all people infected with HIV live in Sub-Saharan Africa. A region also affected with a great burden of other infectious diseases. Relatively few patients have access to anti-retroviral treatment and many suffer from debilitating diarrhea that causes their immune system to deteriorate. Prevention of infectious diseases among HIV patients is of great importance and makes the immune system deteriorate less rapidly. The track record for probiotics to prevent and alleviate infectious diarrhea is impressive. So, the use of probiotics among HIV patients is a logical step and could be an adjunctive tool for physicians to halt the decline of the CD4 count.

Another important application for the use of probiotics is in the treatment of bacterial vaginosis (BV). BV is a vaginal infection, caused by a group of pathogens, which is extremely common, and estimated to occur in 50% of black African women. In the US, the prevalence is 29%, which again is extremely high. This infection makes a woman more vulnerable to contracting sexually transmitted infections, including HIV. Having BV is also a risk factor to transmit HIV to a partner or a newborn. Conventional antibiotic treatment of BV has a cure rate of 40% among black African women. A recent study shows that combining the probiotic strains Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14 with an antibiotic has a cure rate of 88%.

Study Timeline

• Study First Submitted: 2007-09-27
• Study First Submitted QC: 2007-09-27
• Study First Posted: 2007-09-28
• Study Start: 2007-10
• Primary Completion: 2008-08
• Study Completion: 2008-08
• Status Verified: 2009-01
• Last Update Submitted: 2009-01-29
• Last Update Posted: 2009-01-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 65

Inclusion Criteria

• Confirmed HIV infection.
• Participant does not meet the criteria for ARV therapy, CD4 count > 200, no clinical stage 3 or 4 [National guidelines, 2005].
• Having an intermediate Nugent score (4-6), or a positive Nugent score (7-10).

Exclusion Criteria

• Pregnancy or lactating.
• Menstruation at time of diagnosis.
• Hypersensitive to metronidazole/warfarin/lithium/disulfiram.
• Not willing to avoid alcohol use during the metronidazole treatment of 10 days.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B	Metronidazole	Metronidazole for 10 days, placebo for 6 months
A	Lactobacillus rhamnosus GR-1 + Lactobacillus reuteri RC-14	Metronidazole for 10 days, probiotics for 6 months
B	Placebo	Metronidazole for 10 days, placebo for 6 months
A	Metronidazole	Metronidazole for 10 days, probiotics for 6 months

Primary Outcome Measures

Name	Time	Method
CD4 count	assessed at 10 and 25 weeks

Secondary Outcome Measures

Name	Time	Method
Bacterial vaginosis cure rate	assesed at week 2, 5, 15, 25
Total serum IgE levels	baseline and at 10 weeks
Serum cytokine levels	baseline and at 10 weeks
Diarrhea incidence and length of episodes	25 weeks

Trial Locations

Locations (1)

Sekou-Toure Regional Hospital; 🇹🇿 Mwanza, Tanzania