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

Tracking Information
First Submitted Date ICMJE	September 27, 2007
First Posted Date ICMJE	September 28, 2007
Last Update Posted Date	January 30, 2009
Study Start Date ICMJE	October 2007
Estimated Primary Completion Date	August 2008 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: April 17, 2008)	CD4 count [ Time Frame: assessed at 10 and 25 weeks ]
Original Primary Outcome Measures ICMJE; (submitted: September 27, 2007)	CD4 count [ Time Frame: 25 weeks ]
Change History	Complete list of historical versions of study NCT00536848 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: January 29, 2009)	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 ]
Original Secondary Outcome Measures ICMJE; (submitted: September 27, 2007)	Bacterial vaginosis cure rate [ Time Frame: assesed at week 2, 5, 15, 25 ]
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	The Effect of Probiotics on the Immune Status, Diarrhea and Bacterial Vaginosis Cure Rate Among HIV Patients
Official Title ICMJE	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
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%.
Study Type ICMJE	Interventional
Study Phase	Phase 2; Phase 3
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition ICMJE	HIV Infections; Diarrhea; Bacterial Vaginosis
Intervention ICMJE	Dietary Supplement: Lactobacillus rhamnosus GR-1 + Lactobacillus reuteri RC-14; Dietary Supplement: Placebo; Drug: Metronidazole
Study Arms	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
Publications *	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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Unknown status
Actual Enrollment ICMJE; (submitted: April 17, 2008)	65
Original Estimated Enrollment ICMJE; (submitted: September 27, 2007)	60
Estimated Study Completion Date	August 2008
Estimated Primary Completion Date	August 2008 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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.
Sex/Gender	Sexes Eligible for Study: Female
Ages	18 Years to 45 Years (Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Tanzania
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00536848
Other Study ID Numbers ICMJE	MRRC HIV-Probiotics15
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Director, National Institute for Medical Research, Mwanza research centre
Study Sponsor ICMJE	National Institute for Medical Research, Tanzania
Collaborators ICMJE	University of Western Ontario, Canada; Erasmus Medical Center; Sekou-Toure Regional Hosipital, Mwanza, Tanzania; Lawson Health Research Institute; Danone Institute International
Investigators ICMJE	Principal Investigator: John Changalucha, MSc National Institute for Medical Research, Mwanza Research Centre
PRS Account	National Institute for Medical Research, Tanzania
Verification Date	January 2009
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP