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

• Status: Unknown status
• Trial end date: 2008-08-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute for Medical Research, Tanzania
• Collaborators: Danone Institute International; Erasmus Medical Center; Lawson Health Research Institute; Sekou-Toure Regional Hosipital, Mwanza, Tanzania; University of Western Ontario, Canada
• Treatments: Metronidazole

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.