Pilot Study of Oral Probiotic Bacteria Supplementation to Reduce Chronic Immune Activation in HIV-infected Malian Women

NACompletedINTERVENTIONAL
Enrollment

23

Participants

Timeline

Start Date

May 31, 2015

Primary Completion Date

March 31, 2016

Study Completion Date

March 31, 2016

Conditions
HIV
Interventions
OTHER

VSL#3® probiotic

"Other: VSL#3® probiotic VSL#3® DS (Sigma-Tau Pharmaceuticals) is a well characterized water soluble, live (9 × 1011 bacteria/sachet), lyophilized preparation of 8 probiotic bacterium that have been detailed previously. Subjects will take 1 sachet of powder orally daily for 12 weeks. As many Malian homes lack refrigeration, subjects will be issued a special canari, a commonly used earthenware water container also containing sand that works on the principal of trans-evaporation to keep contents at room temperature (\~24°C) even in warmer climates. We have verified this in country. Probiotics will be placed in a sealed plastic bag within a sealed jar in the sand of the canari. At the research site, probiotics will be kept refrigerated (4-8°C) in a study provided refrigerator"

Trial Locations (1)

BP169

Nianankoro Fomba Hospital, Ségou

All Listed Sponsors
collaborator

Bill and Melinda Gates Foundation

OTHER

lead

Virginia Commonwealth University

OTHER

NCT02448238 - Pilot Study of Oral Probiotic Bacteria Supplementation to Reduce Chronic Immune Activation in HIV-infected Malian Women | Biotech Hunter | Biotech Hunter