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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified January 2009 by National Institute for Medical Research, Tanzania.
Recruitment status was: Active, not recruiting

Sponsor:

Collaborators:

University of Western Ontario, Canada

Erasmus Medical Center

Sekou-Toure Regional Hosipital, Mwanza, Tanzania

Lawson Health Research Institute

Danone Institute International

Information provided by:

National Institute for Medical Research, Tanzania

ClinicalTrials.gov Identifier:

NCT00536848

First received: September 27, 2007

Last updated: January 29, 2009

Last verified: January 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

September 27, 2007

Last Updated Date

January 29, 2009

Start Date ^ICMJE

October 2007

Estimated Primary Completion Date

August 2008 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

CD4 count [ Time Frame: assessed at 10 and 25 weeks ]

Original Primary Outcome Measures ^ICMJE

CD4 count [ Time Frame: 25 weeks ]

Change History

Complete list of historical versions of study NCT00536848 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Bacterial vaginosis cure rate [ Time Frame: assesed at week 2, 5, 15, 25 ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief 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.

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 ^ICMJE

Interventional

Study Phase

Phase 2
Phase 3

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

HIV Infections
Diarrhea
Bacterial Vaginosis

Intervention ^ICMJE

Dietary Supplement: Lactobacillus rhamnosus GR-1 + Lactobacillus reuteri RC-14
Dietary Supplement: Placebo
Drug: Metronidazole

Study Arms

Experimental: A
Metronidazole for 10 days, probiotics for 6 months
Interventions:
- Dietary Supplement: Lactobacillus rhamnosus GR-1 + Lactobacillus reuteri RC-14
- Drug: Metronidazole
Placebo Comparator: B
Metronidazole for 10 days, placebo for 6 months
Interventions:
- Dietary Supplement: Placebo
- Drug: Metronidazole

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.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Unknown status

Enrollment ^ICMJE

Estimated Completion Date

August 2008

Estimated Primary Completion Date

August 2008 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Sex/Gender

Sexes Eligible for Study:

Female

Ages

18 Years to 45 Years (Adult)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Tanzania

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00536848

Other Study ID Numbers ^ICMJE

MRRC HIV-Probiotics15

Has Data Monitoring Committee

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Director, National Institute for Medical Research, Mwanza research centre

Study Sponsor ^ICMJE

National Institute for Medical Research, Tanzania

Collaborators ^ICMJE

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

Investigators ^ICMJE

Principal Investigator:

John Changalucha, MSc

National Institute for Medical Research, Mwanza Research Centre

PRS Account

National Institute for Medical Research, Tanzania

Verification Date

January 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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