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Sponsors and Collaborators: |
National Institute for Medical Research, Tanzania University of Western Ontario, Canada Erasmus Medical Center Sekou-Toure Regional Hosipital, Mwanza, Tanzania Lawson Health Research Institute DANONE |
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Information provided by: | National Institute for Medical Research, Tanzania |
ClinicalTrials.gov Identifier: | NCT00536848 |
The purpose of this study is to asses whether probiotics Lactobacillus GR-1 and RC-14 are able to prevent diarrhea, delay the decline of the immune system and prevent and/or cure bacterial vaginosis among HIV patients.
Condition | Intervention | Phase |
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HIV Infections Diarrhea Bacterial Vaginosis |
Dietary Supplement: Lactobacillus rhamnosus GR-1 + Lactobacillus reuteri RC-14 Dietary Supplement: Placebo |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
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 |
Enrollment: | 65 |
Study Start Date: | October 2007 |
Estimated Study Completion Date: | August 2008 |
Estimated Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental
Metronidazole for 10 days, probiotis for 6 months
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Dietary Supplement: Lactobacillus rhamnosus GR-1 + Lactobacillus reuteri RC-14 |
B: Placebo Comparator
Metronidazole for 10 days, placebo for 6 months
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Dietary Supplement: Placebo |
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 to 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.
An other 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%.
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Tanzania | |
Sekou-Toure Regional Hospital | |
Mwanza, Tanzania, p.o. box 1663 |
Principal Investigator: | John Changalucha, MSc | National Institute for Medical Research, Mwanza Research Centre |
Responsible Party: | National Institute for Medical Research, Mwanza research centre ( Director ) |
Study ID Numbers: | MRRC HIV-Probiotics15 |
Study First Received: | September 27, 2007 |
Last Updated: | April 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00536848 |
Health Authority: | Tanzania: Ministry of Health; Tanzania: National Institute for Medical Research |
Probiotics HIV AIDS Diarrhea Lactobacillus Rhamnosus GR-1 |
Lactobacillus Reuteri RC-14 Immune system Infectious Diseases Complementary Therapies Treatment Naive |
Bacterial Infections Sexually Transmitted Diseases, Viral Diarrhea Signs and Symptoms, Digestive Acquired Immunodeficiency Syndrome Vaginitis Vaginal Diseases Immunologic Deficiency Syndromes |
Genital Diseases, Female Virus Diseases Signs and Symptoms Vaginosis, Bacterial HIV Infections Sexually Transmitted Diseases Retroviridae Infections |
RNA Virus Infections Slow Virus Diseases Immune System Diseases Lentivirus Infections Infection |