Maternal Probiotic Intervention to Improve Gut Health - Trial II - Burkina Faso (MPIGH-II)

PHASE2RecruitingINTERVENTIONAL
Enrollment

144

Participants

Timeline

Start Date

July 30, 2025

Primary Completion Date

July 7, 2026

Study Completion Date

June 7, 2027

Conditions
Environmental Enteric Dysfunction (EED)
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

RECRUITING

Agence de Formation de Recherche et d'Expertise en Santé pour l'Afrique, Bobo-Dioulasso

All Listed Sponsors
collaborator

Institut de Recherche en Sciences de la Santé (IRSS)

UNKNOWN

collaborator

Agence de Formation, de Recherche & d'Expertise en Santé pour l'Afrique (AFRICSanté)

UNKNOWN

collaborator

Bill and Melinda Gates Foundation

OTHER

lead

University Ghent

OTHER

NCT07134790 - Maternal Probiotic Intervention to Improve Gut Health - Trial II - Burkina Faso (MPIGH-II) | Biotech Hunter | Biotech Hunter