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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00536848
• Other study ID #: MRRC HIV-Probiotics15
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• First received: September 27, 2007
• Last updated: January 29, 2009
• Start date: October 2007
• Est. completion date: August 2008

Study information

• Verified date: January 2009
• Source: National Institute for Medical Research, Tanzania
• Contact: n/a
• Is FDA regulated: No
• Health authority: Tanzania: Ministry of HealthTanzania: National Institute for Medical Research
• Study type: Interventional

Clinical Trial Summary

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.

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%.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 65
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bacterial Vaginosis
• Diarrhea
• HIV Infections
• Vaginal Diseases
• Vaginosis, Bacterial

Intervention

Dietary Supplement:
• Lactobacillus rhamnosus GR-1 + Lactobacillus reuteri RC-14

• Placebo

Drug:
• Metronidazole

Locations

Country	Name	City	State
Tanzania	Sekou-Toure Regional Hospital	Mwanza

Sponsors (6)

Lead Sponsor	Collaborator
National Institute for Medical Research, Tanzania	Danone Institute International, Erasmus Medical Center, Lawson Health Research Institute, Sekou-Toure Regional Hosipital, Mwanza, Tanzania, University of Western Ontario, Canada

Country where clinical trial is conducted

Tanzania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CD4 count		assessed at 10 and 25 weeks	No
Secondary	Bacterial vaginosis cure rate		assesed at week 2, 5, 15, 25	No
Secondary	Total serum IgE levels		baseline and at 10 weeks	No
Secondary	Serum cytokine levels		baseline and at 10 weeks	No
Secondary	Diarrhea incidence and length of episodes		25 weeks	No

External Links

•   a project of the University of Western Ontario to bring probiotics to the developing world