HIV Infections Clinical Trial
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
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%.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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