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

Primary Purpose

HIV Infections, Diarrhea, Bacterial Vaginosis

Status
Unknown status
Phase
Phase 2
Locations
Tanzania
Study Type
Interventional
Intervention
Lactobacillus rhamnosus GR-1 + Lactobacillus reuteri RC-14
Placebo
Metronidazole
Sponsored by
National Institute for Medical Research, Tanzania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Probiotics, HIV, AIDS, Diarrhea, Lactobacillus rhamnosus GR-1, Lactobacillus reuteri RC-14, Immune system, Infectious Diseases, Complementary Therapies, Treatment Naive

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Sekou-Toure Regional Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

A

B

Arm Description

Metronidazole for 10 days, probiotics for 6 months

Metronidazole for 10 days, placebo for 6 months

Outcomes

Primary Outcome Measures

CD4 count

Secondary Outcome Measures

Bacterial vaginosis cure rate
Total serum IgE levels
Serum cytokine levels
Diarrhea incidence and length of episodes

Full Information

First Posted
September 27, 2007
Last Updated
January 29, 2009
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
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1. Study Identification

Unique Protocol Identification Number
NCT00536848
Brief Title
The Effect of Probiotics on the Immune Status, Diarrhea and Bacterial Vaginosis Cure Rate Among HIV Patients
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 Type
Interventional

2. Study Status

Record Verification Date
January 2009
Overall Recruitment Status
Unknown status
Study Start Date
October 2007 (undefined)
Primary Completion Date
August 2008 (Anticipated)
Study Completion Date
August 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the 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

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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%.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Diarrhea, Bacterial Vaginosis
Keywords
Probiotics, HIV, AIDS, Diarrhea, Lactobacillus rhamnosus GR-1, Lactobacillus reuteri RC-14, Immune system, Infectious Diseases, Complementary Therapies, Treatment Naive

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
Metronidazole for 10 days, probiotics for 6 months
Arm Title
B
Arm Type
Placebo Comparator
Arm Description
Metronidazole for 10 days, placebo for 6 months
Intervention Type
Dietary Supplement
Intervention Name(s)
Lactobacillus rhamnosus GR-1 + Lactobacillus reuteri RC-14
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Type
Drug
Intervention Name(s)
Metronidazole
Primary Outcome Measure Information:
Title
CD4 count
Time Frame
assessed at 10 and 25 weeks
Secondary Outcome Measure Information:
Title
Bacterial vaginosis cure rate
Time Frame
assesed at week 2, 5, 15, 25
Title
Total serum IgE levels
Time Frame
baseline and at 10 weeks
Title
Serum cytokine levels
Time Frame
baseline and at 10 weeks
Title
Diarrhea incidence and length of episodes
Time Frame
25 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Changalucha, MSc
Organizational Affiliation
National Institute for Medical Research, Mwanza Research Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sekou-Toure Regional Hospital
City
Mwanza
ZIP/Postal Code
p.o. box 1663
Country
Tanzania

12. IPD Sharing Statement

Citations:
PubMed Identifier
20801446
Citation
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.
Results Reference
derived
Links:
URL
http://www.westernheadseast.ca
Description
a project of the University of Western Ontario to bring probiotics to the developing world

Learn more about this trial

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

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