The Effect of Probiotics on the Immune Status, Diarrhea and Bacterial Vaginosis Cure Rate Among HIV Patients
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ClinicalTrials.gov Identifier: NCT00536848 |
Recruitment Status
: Unknown
Verified January 2009 by National Institute for Medical Research, Tanzania.
Recruitment status was: Active, not recruiting
First Posted
: September 28, 2007
Last Update Posted
: January 30, 2009
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections Diarrhea Bacterial Vaginosis | Dietary Supplement: Lactobacillus rhamnosus GR-1 + Lactobacillus reuteri RC-14 Dietary Supplement: Placebo Drug: Metronidazole | Phase 2 Phase 3 |
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%.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 65 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
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 |
Study Start Date : | October 2007 |
Estimated Primary Completion Date : | August 2008 |
Estimated Study Completion Date : | August 2008 |

Arm | Intervention/treatment |
---|---|
Experimental: A
Metronidazole for 10 days, probiotics for 6 months
|
Dietary Supplement: Lactobacillus rhamnosus GR-1 + Lactobacillus reuteri RC-14 Drug: Metronidazole |
Placebo Comparator: B
Metronidazole for 10 days, placebo for 6 months
|
Dietary Supplement: Placebo Drug: Metronidazole |
- CD4 count [ Time Frame: assessed at 10 and 25 weeks ]
- Bacterial vaginosis cure rate [ Time Frame: assesed at week 2, 5, 15, 25 ]
- Total serum IgE levels [ Time Frame: baseline and at 10 weeks ]
- Serum cytokine levels [ Time Frame: baseline and at 10 weeks ]
- Diarrhea incidence and length of episodes [ Time Frame: 25 weeks ]

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Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00536848
Tanzania | |
Sekou-Toure Regional Hospital | |
Mwanza, Tanzania, p.o. box 1663 |
Principal Investigator: | John Changalucha, MSc | National Institute for Medical Research, Mwanza Research Centre |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Director, National Institute for Medical Research, Mwanza research centre |
ClinicalTrials.gov Identifier: | NCT00536848 History of Changes |
Other Study ID Numbers: |
MRRC HIV-Probiotics15 |
First Posted: | September 28, 2007 Key Record Dates |
Last Update Posted: | January 30, 2009 |
Last Verified: | January 2009 |
Keywords provided by National Institute for Medical Research, Tanzania:
Probiotics HIV AIDS Diarrhea Lactobacillus rhamnosus GR-1 |
Lactobacillus reuteri RC-14 Immune system Infectious Diseases Complementary Therapies Treatment Naive |
Additional relevant MeSH terms:
HIV Infections Diarrhea Vaginal Diseases Vaginosis, Bacterial Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes |
Immune System Diseases Signs and Symptoms, Digestive Signs and Symptoms Genital Diseases, Female Bacterial Infections Vaginitis Metronidazole Anti-Infective Agents Antiprotozoal Agents Antiparasitic Agents |