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

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ClinicalTrials.gov Identifier: NCT00536848
Recruitment Status : Unknown
Verified January 2009 by National Institute for Medical Research, Tanzania.
Recruitment status was:  Active, not recruiting
First Posted : September 28, 2007
Last Update Posted : January 30, 2009
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

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment 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

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
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
Study Start Date : October 2007
Estimated Primary Completion Date : August 2008
Estimated Study Completion Date : August 2008

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. CD4 count [ Time Frame: assessed at 10 and 25 weeks ]

Secondary Outcome Measures :
  1. Bacterial vaginosis cure rate [ Time Frame: assesed at week 2, 5, 15, 25 ]
  2. Total serum IgE levels [ Time Frame: baseline and at 10 weeks ]
  3. Serum cytokine levels [ Time Frame: baseline and at 10 weeks ]
  4. Diarrhea incidence and length of episodes [ Time Frame: 25 weeks ]

Eligibility Criteria
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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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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):

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 Posted: September 28, 2007    Key Record Dates
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