Maternal Probiotic Intervention to Improve Gut Health

PHASE2CompletedINTERVENTIONAL
Enrollment

76

Participants

Timeline

Start Date

August 9, 2023

Primary Completion Date

June 30, 2024

Study Completion Date

June 30, 2025

Conditions
Environmental Enteric DysfunctionStunting
Interventions
DRUG

Vivomixx

"Vivomixx (a mixture of Lactobacillus acidophilus, Lactobacillus plantarum, Lactobacillus casei, Lactobacillus delbrueckii subspecies bulgaricus, Streptococcus salivarius subspecies thermophiles, Bifidobacterium breve, Bifidobacterium longum, and Bifidobacterium infantis), as VivomixxAll consenting participants will be randomized into the treatment to control arm, receiving either Vivomixx or a placebo for 8 weeks.~During the study, women will visit the healthcare center or vice-versa on a bi-weekly basis to receive sachets of Vivomixx or a placebo according to their trial arm."

DEVICE

CapScan®

"The only non-standard sample collection instrument is the CapScan device. The CapScan Collection Capsule (Capsule) is a non-invasive device that collects gastrointestinal samples along the GI tract that are then analyzed outside the body. Samples collected by the Capsule will be expressed, then undergo DNA sequencing and mass spectrometric analysis to determine the identity and function of the bacterial and host cells in the different regions of the GI tract and compared to similar analyses conducted on concomitantly collected stool samples."

Trial Locations (1)

71000

Mother and Child Health Research and Training Center, Matiari

All Listed Sponsors
collaborator

Bill and Melinda Gates Foundation

OTHER

collaborator

International Centre for Diarrhoeal Disease Research, Bangladesh

OTHER

collaborator

University of Zambia

OTHER

collaborator

Institut Pasteur de Dakar

OTHER

lead

Aga Khan University

OTHER