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

Study Overview
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Brief Summary
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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
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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%.

Official Title
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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

Conditions
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HIV Infections, Diarrhea, Bacterial Vaginosis

Intervention / Treatment
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* Dietary Supplement: Lactobacillus rhamnosus GR-1 + Lactobacillus reuteri RC-14
* Dietary Supplement: Placebo
* Drug: Metronidazole


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Metronidazole for 10 days, probiotics for 6 months | Dietary Supplement: Lactobacillus rhamnosus GR-1 + Lactobacillus reuteri RC-14<br> <br> Drug: Metronidazole<br> <br> |
| Placebo Comparator: B<br>Metronidazole for 10 days, placebo for 6 months | Dietary Supplement: Placebo<br> <br> Drug: Metronidazole<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CD4 count |  | assessed at 10 and 25 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bacterial vaginosis cure rate |  | assesed at week 2, 5, 15, 25 | 
| Total serum IgE levels |  | baseline and at 10 weeks | 
| Serum cytokine levels |  | baseline and at 10 weeks | 
| Diarrhea incidence and length of episodes |  | 25 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Probiotics, HIV, AIDS, Diarrhea, Lactobacillus rhamnosus GR-1, Lactobacillus reuteri RC-14, Immune system, Infectious Diseases, Complementary Therapies, Treatment Naive