Maternal Probiotic Intervention to Improve Gut Health - Trial II - Bangladesh

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

144

Participants

Timeline

Start Date

April 30, 2025

Primary Completion Date

April 30, 2026

Study Completion Date

October 31, 2026

Conditions
Environmental Enteric Dysfunction
Interventions
DRUG

VE818

VE818, is an 11-strain bacterial consortium rationally designed by Vedanta Biosciences Inc., to displace enteropathogens and reduce intestinal inflammation in pregnant women

DRUG

Placebo

Enteric Capsules filled with approximately 400mg of Microcrystalline Cellulose (bulking agent)

DRUG

Oral Vancomycin

Oral vancomycin in capsule form will be administered three times daily for 5 days at 250mg per dose. Because oral vancomycin is a non-absorbable antibiotic, the likelihood of systemic absorption is minimal and therefore, it is not associated with the adverse events attributable to the intravenous formulation

Trial Locations (1)

Unknown

International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), Matlab

All Listed Sponsors
collaborator

Bill and Melinda Gates Foundation

OTHER

lead

International Centre for Diarrhoeal Disease Research, Bangladesh

OTHER