MedTrace Logo

Maternal Probiotic Intervention to Improve Gut Health

NCT06196450 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2024-01-17

No results posted yet for this study

Summary

This trial will determine if a well-established probiotic, Vivomixx, can modulate maternal microbiota and ameliorate maternal environmental enteropathy which compromises growth in the first 1000 days. The probiotic Vivomixx has been used in many thousands of people including pregnant women, both within and outside a research context. This trial is the first in a proposed series of proof-of-concept intervention studies which are intended to provide data to enable a rational selection of interventions to be evaluated at scale in future large scale trials in which birth outcomes and postnatal growth will be key endpoints.

Conditions

  • Environmental Enteric Dysfunction
  • Gut Microbiota Dysbiosis

Interventions

DIETARY_SUPPLEMENT

Vivomixx

Vivomixx is a commercially available probiotic mixture consisting of eight probiotic lactic acid bacteria and Bifidobacteria including Lactobacillus acidophilus, Lactobacillus plantarum, Lactobacillus casei, Lactobacillus delbrueckii subspecies bulgaricus, Streptococcus salivarius subspecies thermophiles, Bifidobacterium breve, Bifidobacterium longum, and Bifidobacterium infantis.

DIETARY_SUPPLEMENT

Microcrystalline maltose

Microcrystalline maltose as placebo

Sponsors & Collaborators

  • Bill and Melinda Gates Foundation

    collaborator OTHER

  • International Centre for Diarrhoeal Disease Research, Bangladesh

    lead OTHER

Principal Investigators

  • S. M. Tafsir Hasan, MBBS, MS · Nutrition Research Division, icddr,b

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-22
Primary Completion
2024-03-31
Completion
2025-03-31

Countries

  • Bangladesh

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06196450 on ClinicalTrials.gov