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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 because the information has not been verified recently.
Verified January 2009 by National Institute for Medical Research, Tanzania.
Recruitment status was  Active, not recruiting
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
ClinicalTrials.gov Identifier:
NCT00536848
First received: September 27, 2007
Last updated: January 29, 2009
Last verified: January 2009

September 27, 2007
January 29, 2009
October 2007
August 2008   (final data collection date for primary outcome measure)
CD4 count [ Time Frame: assessed at 10 and 25 weeks ] [ Designated as safety issue: No ]
CD4 Count [ Time Frame: 25 weeks ]
Complete list of historical versions of study NCT00536848 on ClinicalTrials.gov Archive Site
  • 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 ]
Bacterial vaginosis cure rate [ Time Frame: assesed at week 2, 5, 15, 25 ]
Not Provided
Not Provided
 
The Effect of Probiotics on the Immune Status, Diarrhea and Bacterial Vaginosis Cure Rate Among HIV Patients
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

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.

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%.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • HIV Infections
  • Diarrhea
  • Bacterial Vaginosis
  • Dietary Supplement: Lactobacillus rhamnosus GR-1 + Lactobacillus reuteri RC-14
  • Dietary Supplement: Placebo
  • Drug: Metronidazole
  • Experimental: A
    Metronidazole for 10 days, probiotics for 6 months
    Interventions:
    • Dietary Supplement: Lactobacillus rhamnosus GR-1 + Lactobacillus reuteri RC-14
    • Drug: Metronidazole
  • Placebo Comparator: B
    Metronidazole for 10 days, placebo for 6 months
    Interventions:
    • Dietary Supplement: Placebo
    • Drug: Metronidazole
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
65
August 2008
August 2008   (final data collection date for primary outcome measure)

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.
Female
18 Years to 45 Years
No
Contact information is only displayed when the study is recruiting subjects
Tanzania
 
NCT00536848
MRRC HIV-Probiotics15
No
Director, National Institute for Medical Research, Mwanza research centre
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
Principal Investigator: John Changalucha, MSc National Institute for Medical Research, Mwanza Research Centre
National Institute for Medical Research, Tanzania
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP