Overview

This trial is active, not recruiting.

Conditions hiv infections, diarrhea, bacterial vaginosis
Treatments lactobacillus rhamnosus gr-1 + lactobacillus reuteri rc-14, placebo, metronidazole
Phase phase 2/phase 3
Sponsor National Institute for Medical Research, Tanzania
Collaborator University of Western Ontario, Canada
Start date October 2007
End date August 2008
Trial size 65 participants
Trial identifier NCT00536848, MRRC HIV-Probiotics15

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Metronidazole for 10 days, probiotics for 6 months
lactobacillus rhamnosus gr-1 + lactobacillus reuteri rc-14
metronidazole
(Placebo Comparator)
Metronidazole for 10 days, placebo for 6 months
placebo
metronidazole

Primary Outcomes

Measure
CD4 count
time frame: assessed at 10 and 25 weeks

Secondary Outcomes

Measure
Bacterial vaginosis cure rate
time frame: assesed at week 2, 5, 15, 25
Total serum IgE levels
time frame: baseline and at 10 weeks
Serum cytokine levels
time frame: baseline and at 10 weeks
Diarrhea incidence and length of episodes
time frame: 25 weeks

Eligibility Criteria

Female participants from 18 years up to 45 years old.

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.

Additional Information

Official title 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
Principal investigator John Changalucha, MSc
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%.
Trial information was received from ClinicalTrials.gov and was last updated in January 2009.
Information provided to ClinicalTrials.gov by National Institute for Medical Research, Tanzania.