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 because the information has not been verified recently.

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

First Received on September 27, 2007. Last Updated on January 29, 2009 History of Changes

Sponsor:	National Institute for Medical Research, Tanzania
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

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 II Phase III

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

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: Diarrhea HIV/AIDS

Drug Information available for: Metronidazole hydrochloride Metronidazole phosphate Metronidazole

U.S. FDA Resources

Further study details as provided by National Institute for Medical Research, Tanzania:

Primary Outcome Measures:

CD4 count [ Time Frame: assessed at 10 and 25 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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

Criteria

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 Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00536848

Locations

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

Sponsors and Collaborators

National Institute for Medical Research, Tanzania

University of Western Ontario, Canada

Erasmus Medical Center

Sekou-Toure Regional Hosipital, Mwanza, Tanzania

Lawson Health Research Institute

Danone Institute International

Investigators

Principal Investigator:

John Changalucha, MSc

National Institute for Medical Research, Mwanza Research Centre

More Information

Additional Information:

a project of the University of Western Ontario to bring probiotics to the developing world This link exits the ClinicalTrials.gov site

No publications provided by National Institute for Medical Research, Tanzania

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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:

HIV Infections
Acquired Immunodeficiency Syndrome
Diarrhea
Vaginosis, Bacterial
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Signs and Symptoms, Digestive

Signs and Symptoms
Bacterial Infections
Vaginitis
Vaginal Diseases
Genital Diseases, Female
Metronidazole
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Infective Agents
Therapeutic Uses
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on February 12, 2012