A Phase 2/3 interventional study of Lactobacillus rhamnosus GR-1 + Lactobacillus reuteri RC-14 and Placebo in HIV Infections, Diarrhea and Bacterial Vaginosis, sponsored by National Institute for Medical Research, Tanzania. Status unknown at 1 site in Tanzania. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2009-01-30.
Sponsored by National Institute for Medical Research, Tanzania · Phase 2/3, Interventional, and Treatment
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.
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%.
220 studies on the registry are indexed under Vaginosis, Bacterial; 36 are open to participants now.
This study's enrollment of 65 is below the median of 100 across 187 interventional studies indexed under Vaginosis, Bacterial.
Browse Vaginosis, Bacterial studies →National Institute for Medical Research, Tanzania is the lead sponsor of 14 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Metronidazole for 10 days, probiotics for 6 months
Dietary Supplement: Lactobacillus rhamnosus GR-1 + Lactobacillus reuteri RC-14 · Drug: Metronidazole
Metronidazole for 10 days, placebo for 6 months
Dietary Supplement: Placebo · Drug: Metronidazole
CD4 count
Time frame: assessed at 10 and 25 weeks
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
This study is status unknown, as verified in Jan 2009. You cannot join it, but the record below documents what was studied.
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National Institute for Medical Research, Tanzania