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| Name | Class |
|---|---|
| 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 |
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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.
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%.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Metronidazole for 10 days, probiotics for 6 months |
|
| B | Placebo Comparator | Metronidazole for 10 days, placebo for 6 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactobacillus rhamnosus GR-1 + Lactobacillus reuteri RC-14 | Dietary Supplement |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| CD4 count | assessed at 10 and 25 weeks |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Changalucha, MSc | National Institute for Medical Research, Mwanza Research Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sekou-Toure Regional Hospital | Mwanza | p.o. box 1663 | Tanzania |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20801446 | Derived | 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. |
| Label | URL |
|---|---|
| a project of the University of Western Ontario to bring probiotics to the developing world | View source |
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| OTHER |
| Danone Institute International | OTHER |
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| Dietary Supplement |
|
| Metronidazole | Drug |
|
| baseline and at 10 weeks |
| Diarrhea incidence and length of episodes | 25 weeks |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D003967 | Diarrhea |
| D016585 | Vaginosis, Bacterial |
| D000163 | Acquired Immunodeficiency Syndrome |
| D003141 | Communicable Diseases |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D014627 | Vaginitis |
| D014623 | Vaginal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D012897 | Slow Virus Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D008795 | Metronidazole |
| ID | Term |
|---|---|
| D009593 | Nitroimidazoles |
| D009574 | Nitro Compounds |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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