The Effect of Probiotics on the Immune Status, Diarrhea and Bacterial Vaginosis Cure Rate Among HIV Patients
Recruitment status was Active, not recruiting
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Purpose
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.
| Condition | Intervention | 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 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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 |
- CD4 count [ Time Frame: assessed at 10 and 25 weeks ] [ Designated as safety issue: No ]
- Bacterial vaginosis cure rate [ Time Frame: assesed at week 2, 5, 15, 25 ] [ Designated as safety issue: No ]
- Total serum IgE levels [ Time Frame: baseline and at 10 weeks ] [ Designated as safety issue: No ]
- Serum cytokine levels [ Time Frame: baseline and at 10 weeks ] [ Designated as safety issue: No ]
- Diarrhea incidence and length of episodes [ Time Frame: 25 weeks ] [ Designated as safety issue: No ]
| 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 |
|---|---|
|
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 |
Detailed Description:
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%.
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders 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.
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: 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 |
More Information
Additional Information:
No publications provided by National Institute for Medical Research, Tanzania
Additional 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 |
| Study First Received: | September 27, 2007 |
| Last Updated: | January 29, 2009 |
| Health Authority: | Tanzania: Ministry of Health Tanzania: National Institute for Medical Research |
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:
|
Diarrhea Vaginosis, Bacterial Bacterial Infections Genital Diseases, Female Signs and Symptoms Signs and Symptoms, Digestive Vaginal Diseases Vaginitis |
Metronidazole Anti-Infective Agents Antiparasitic Agents Antiprotozoal Agents Pharmacologic Actions Radiation-Sensitizing Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on February 27, 2015