NCT00536848

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

The Effect of Probiotic Supplementation With Lactobacillus GR-1 and RC-14,on the Immune Status, Diarrhea and Bacterial Vaginosis Cure Rate Among HIV Patients; a Randomised, Placebo Controlled Trial

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: National Institute for Medical Research, Tanzania · Other Government
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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%.

Conditions

• HIV Infections
• Diarrhea
• Bacterial Vaginosis

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Lactobacillus rhamnosus GR-1 + Lactobacillus reuteri RC-14
DIETARY_SUPPLEMENT	Placebo
DRUG	Metronidazole

Timeline

• Start date: 2007-10-01
• Primary completion: 2008-08-01
• Completion: 2008-08-01
• First posted: 2007-09-28
• Last updated: 2009-01-30

Locations

1 site across 1 country: Tanzania