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

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

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.

Study Overview

• Status: Unknown
• Conditions: HIV Infections; Diarrhea; Bacterial Vaginosis
• Intervention / Treatment: Drug: Metronidazole; Dietary supplement: Placebo; Dietary supplement: Lactobacillus rhamnosus GR-1 + Lactobacillus reuteri RC-14

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%.

• Study Type: Interventional
• Enrollment (Actual): 65
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Tanzania
  • Mwanza, Tanzania, p.o. box 1663
    • Sekou-Toure Regional Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 41 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: National Institute for Medical Research, Tanzania
• Collaborators: Erasmus Medical Center; Lawson Health Research Institute; University of Western Ontario, Canada; Danone Institute International; Sekou-Toure Regional Hosipital, Mwanza, Tanzania
• Investigators: Principal Investigator: John Changalucha, MSc, National Institute for Medical Research, Mwanza Research Centre

Publications and helpful links

General Publications

• 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.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: October 1, 2007
• Primary Completion (Anticipated): August 1, 2008
• Study Completion (Anticipated): August 1, 2008

Study Registration Dates

• First Submitted: September 27, 2007
• First Submitted That Met QC Criteria: September 27, 2007
• First Posted (Estimate): September 28, 2007

Study Record Updates

• Last Update Posted (Estimate): January 30, 2009
• Last Update Submitted That Met QC Criteria: January 29, 2009
• Last Verified: January 1, 2009

More Information

Terms related to this study

• Keywords: Diarrhea; HIV; Probiotics; AIDS; Infectious Diseases; Treatment Naive; Complementary Therapies; Immune system; Lactobacillus rhamnosus GR-1; Lactobacillus reuteri RC-14
• Additional Relevant MeSH Terms: Infections; Signs and Symptoms, Digestive; Bacterial Infections; Bacterial Infections and Mycoses; Vaginitis; Diarrhea; Vaginal Diseases; Vaginosis, Bacterial; Anti-Infective Agents; Anti-Bacterial Agents; Antiprotozoal Agents; Antiparasitic Agents; Metronidazole
• Other Study ID Numbers: MRRC HIV-Probiotics15