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

Purpose

The purpose of this study is to asses whether probiotics Lactobacillus GR-1 and 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	Phase II Phase III

MedlinePlus related topics:

AIDS Diarrhea Dietary Supplements

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

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

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

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 to 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.

An other 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

Investigators


Principal Investigator:	John Changalucha, MSc	National Institute for Medical Research, Mwanza Research Centre

More Information

a project of the university of western ontario to bring probiotics to the developing world This link exits the ClinicalTrials.gov site

Responsible Party:	National Institute for Medical Research, Mwanza research centre ( Director )
Study ID Numbers:	MRRC HIV-Probiotics15
First Received:	September 27, 2007
Last Updated:	April 17, 2008
ClinicalTrials.gov Identifier:	NCT00536848
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

Study placed in the following topic categories:

Bacterial Infections

Sexually Transmitted Diseases, Viral

Diarrhea

Signs and Symptoms, Digestive

Acquired Immunodeficiency Syndrome

Vaginitis

Vaginal Diseases

Immunologic Deficiency Syndromes

Genital Diseases, Female

Virus Diseases

Signs and Symptoms

Vaginosis, Bacterial

HIV Infections

Sexually Transmitted Diseases

Retroviridae Infections

Additional relevant MeSH terms:

RNA Virus Infections

Slow Virus Diseases

Immune System Diseases

Lentivirus Infections

Infection

ClinicalTrials.gov processed this record on October 24, 2008

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
Information provided by:	National Institute for Medical Research, Tanzania
ClinicalTrials.gov Identifier:	NCT00536848