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

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

Sponsors

Lead sponsor: National Institute for Medical Research, Tanzania

Collaborator: University of Western Ontario, Canada
Erasmus Medical Center
Sekou-Toure Regional Hosipital, Mwanza, Tanzania
Lawson Health Research Institute
Danone Institute International

Source 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%.

Overall Status Unknown status
Start Date October 2007
Completion Date August 2008
Primary Completion Date August 2008
Phase Phase 2/Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
CD4 count assessed at 10 and 25 weeks
Secondary Outcome
Measure Time Frame
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
Enrollment 65
Condition
Intervention

Intervention type: Dietary Supplement

Intervention name: Lactobacillus rhamnosus GR-1 + Lactobacillus reuteri RC-14

Arm group label: A

Intervention type: Dietary Supplement

Intervention name: Placebo

Arm group label: B

Intervention type: Drug

Intervention name: Metronidazole

Eligibility

Criteria:

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.

Gender: Female

Minimum age: 18 Years

Maximum age: 45 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
John Changalucha, MSc Principal Investigator National Institute for Medical Research, Mwanza Research Centre
Location
facility Sekou-Toure Regional Hospital
Location Countries

Tanzania

Verification Date

January 2009

Responsible Party

Name title: Director

Organization: National Institute for Medical Research, Mwanza research centre

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: A

Arm group type: Experimental

Description: Metronidazole for 10 days, probiotics for 6 months

Arm group label: B

Arm group type: Placebo Comparator

Description: Metronidazole for 10 days, placebo for 6 months

Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov