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

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

Status
UNKNOWN
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00536848
Enrollment
65
Registered
2007-09-28
Start date
2007-10-31
Completion date
2008-08-31
Last updated
2009-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bacterial Vaginosis, Diarrhea, HIV Infections

Keywords

Probiotics, HIV, AIDS, Diarrhea, Lactobacillus rhamnosus GR-1, Lactobacillus reuteri RC-14, Immune system, Infectious Diseases, Complementary Therapies, Treatment Naive

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%.

Interventions

DIETARY_SUPPLEMENTLactobacillus rhamnosus GR-1 + Lactobacillus reuteri RC-14
DIETARY_SUPPLEMENTPlacebo
DRUGMetronidazole

Sponsors

University of Western Ontario, Canada
CollaboratorOTHER
Erasmus Medical Center
CollaboratorOTHER
Sekou-Toure Regional Hosipital, Mwanza, Tanzania
CollaboratorUNKNOWN
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
CollaboratorOTHER
Danone Institute International
CollaboratorOTHER
National Institute for Medical Research, Tanzania
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
CD4 countassessed at 10 and 25 weeks

Secondary

MeasureTime frame
Bacterial vaginosis cure rateassesed at week 2, 5, 15, 25
Total serum IgE levelsbaseline and at 10 weeks
Serum cytokine levelsbaseline and at 10 weeks
Diarrhea incidence and length of episodes25 weeks

Countries

Tanzania

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 30, 2026