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

• Bacterial vaginosis cure rate [ Time Frame: assesed at week 2, 5, 15, 25 ] [ Designated as safety issue: No ]
• Total serum IgE levels [ Time Frame: baseline and at 10 weeks ] [ Designated as safety issue: No ]
• Serum cytokine levels [ Time Frame: baseline and at 10 weeks ] [ Designated as safety issue: No ]
• Diarrhea incidence and length of episodes [ Time Frame: 25 weeks ] [ Designated as safety issue: No ]

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%.

• HIV Infections
• Diarrhea
• Bacterial Vaginosis

• Dietary Supplement: Lactobacillus rhamnosus GR-1 + Lactobacillus reuteri RC-14
• Dietary Supplement: Placebo
• Drug: Metronidazole

• Experimental: A
  Metronidazole for 10 days, probiotics for 6 months
  Interventions:

  • Dietary Supplement: Lactobacillus rhamnosus GR-1 + Lactobacillus reuteri RC-14
  • Drug: Metronidazole
• Placebo Comparator: B
  Metronidazole for 10 days, placebo for 6 months
  Interventions:

  • Dietary Supplement: Placebo
  • Drug: Metronidazole

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.

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