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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:

ClinicalTrials.gov Identifier:

NCT00536848

First Posted: September 28, 2007

Last Update Posted: January 30, 2009

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

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

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 2 Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, 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:

MedlinePlus related topics: Diarrhea HIV/AIDS Vaginal Diseases

Drug Information available for: 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 ]

Secondary Outcome Measures:

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 ]


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

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 45 Years (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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. doi: 10.1016/j.ijgo.2010.07.008.


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
First Submitted:	September 27, 2007
First Posted:	September 28, 2007
Last Update Posted:	January 30, 2009
Last Verified:	January 2009

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 Diarrhea Vaginal Diseases Vaginosis, Bacterial Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes	Immune System Diseases Signs and Symptoms, Digestive Signs and Symptoms Genital Diseases, Female Bacterial Infections Vaginitis Metronidazole Anti-Infective Agents Antiprotozoal Agents Antiparasitic Agents

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