Clinical trial NCT00536848: The Effect of Probiotics on the Immune Status, Diarrhea and Bacterial Vaginosis Cure Rate Among HIV Patients
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: HIV Infections
Diarrhea
Bacterial Vaginosis
Keywords: Probiotics
HIV
AIDS
Diarrhea
Lactobacillus rhamnosus GR-1
Lactobacillus reuteri RC-14
Immune system
Infectious Diseases
Complementary Therapies
Treatment Naive
Lead sponsor: National Institute for Medical Research, Tanzania
Sponsor class: OTHER_GOV
Collaborators: name: University of Western Ontario, Canada
name: Erasmus Medical Center
name: Sekou-Toure Regional Hosipital, Mwanza, Tanzania
name: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
name: Danone Institute International
First posted: 2007-09-28
Enrollment: 65
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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%.

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.

Primary outcomes:
measure: CD4 count
timeFrame: assessed at 10 and 25 weeks
Secondary outcomes:
measure: Bacterial vaginosis cure rate
timeFrame: assesed at week 2, 5, 15, 25
measure: Total serum IgE levels
timeFrame: baseline and at 10 weeks
measure: Serum cytokine levels
timeFrame: baseline and at 10 weeks
measure: Diarrhea incidence and length of episodes
timeFrame: 25 weeks
Other outcomes:
Locations:
city: Mwanza
country: Tanzania
facility: Sekou-Toure Regional Hospital
Study officials:
affiliation: National Institute for Medical Research, Mwanza Research Centre
name: John Changalucha, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hummelen R, Changalucha J, Butamanya NL, Cook A, Habbema JD, Reid G. Lactobacillus rhamnosus GR-1 and L. reuteri RC-14 to prevent or cure bacterial vaginosis among women with HIV. Int J Gynaecol Obstet. 2010 Dec;111(3):245-8. doi: 10.1016/j.ijgo.2010.07.008.