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

NCT00536848 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2009-01-30

No results posted yet for this study

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.

Conditions

  • HIV Infections
  • Diarrhea
  • Bacterial Vaginosis

Interventions

DIETARY_SUPPLEMENT

Lactobacillus rhamnosus GR-1 + Lactobacillus reuteri RC-14

DIETARY_SUPPLEMENT

Placebo

DRUG

Metronidazole

Sponsors & Collaborators

  • University of Western Ontario, Canada

    collaborator OTHER

  • Erasmus Medical Center

    collaborator OTHER

  • Sekou-Toure Regional Hosipital, Mwanza, Tanzania

    collaborator UNKNOWN

  • London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

    collaborator OTHER

  • Danone Institute International

    collaborator OTHER

  • National Institute for Medical Research, Tanzania

    lead OTHER_GOV

Principal Investigators

  • John Changalucha, MSc · National Institute for Medical Research, Mwanza Research Centre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2008-08-31
Completion
2008-08-31

Countries

  • Tanzania

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00536848 on ClinicalTrials.gov