The Effect of Probiotics on the Immune Status, Diarrhea and Bacterial Vaginosis Cure Rate Among HIV Patients
NCT ID: NCT00536848
Last Updated: 2009-01-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
65 participants
INTERVENTIONAL
2007-10-31
2008-08-31
Brief Summary
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Detailed Description
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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%.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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A
Metronidazole for 10 days, probiotics for 6 months
Lactobacillus rhamnosus GR-1 + Lactobacillus reuteri RC-14
Metronidazole
B
Metronidazole for 10 days, placebo for 6 months
Placebo
Metronidazole
Interventions
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Lactobacillus rhamnosus GR-1 + Lactobacillus reuteri RC-14
Placebo
Metronidazole
Eligibility Criteria
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Inclusion Criteria
* 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
* Menstruation at time of diagnosis.
* Hypersensitive to metronidazole/warfarin/lithium/disulfiram.
* Not willing to avoid alcohol use during the metronidazole treatment of 10 days.
18 Years
45 Years
FEMALE
No
Sponsors
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University of Western Ontario, Canada
OTHER
Erasmus Medical Center
OTHER
Sekou-Toure Regional Hosipital, Mwanza, Tanzania
UNKNOWN
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
OTHER
Danone Institute International
OTHER
National Institute for Medical Research, Tanzania
OTHER_GOV
Responsible Party
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National Institute for Medical Research, Mwanza research centre
Principal Investigators
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John Changalucha, MSc
Role: PRINCIPAL_INVESTIGATOR
National Institute for Medical Research, Mwanza Research Centre
Locations
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Sekou-Toure Regional Hospital
Mwanza, , Tanzania
Countries
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References
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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.
Related Links
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a project of the University of Western Ontario to bring probiotics to the developing world
Other Identifiers
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MRRC HIV-Probiotics15
Identifier Type: -
Identifier Source: org_study_id