Ability of the Probiotic Vivomixx to Improve Environmental Enteropathy in Pregnant Women: a Proof of Concept Trial in Bangladesh, Pakistan, Senegal and Zambia

Summary

This trial will determine if a well-established probiotic, Vivomixx, can modulate the maternal microbiota and ameliorate the 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 phase 2 trial in which birth outcomes and postnatal growth will be key endpoints.

Conditions

• Environmental Enteropathy

Interventions

DIETARY_SUPPLEMENT

VSL#3

VSL#3 is a commercial 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. VSL#3 contributes to balancing the gut and vaginal microbiota and is used as a food supplement for management of diseases like irritable bowel syndrome, ulcerative colitis or ileal pouch.

DEVICE

Capscan device

The CapScan device is a short-term single-use class IIa ingestible medical device that collects fluids from the gastrointestinal ("GI") tract and is collected in the stool. GI samples are then extracted from the device and analyzed outside the body.

COMBINATION_PRODUCT

Placebo

microcrystalline cellulose

Sponsors & Collaborators

• Bill and Melinda Gates Foundation

  collaborator OTHER

• Tropical Gastroenterology & Nutrition Group (TROPGAN)

  lead OTHER

Principal Investigators

• Paul Kelly, Dr · Tropical Gastroenterology & Nutrition Group (TROPGAN)

• Yakhya Dieye, Dr · Institut Pasteur de Dakar

• Fyezah Jehan, Dr · Aga Khan University

• Asad Ali, Dr · Aga Khan University

• Tahmeed Ahmed, Dr · International Centre for Diarrhoeal Disease Research, Bangladesh

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-12-01

Primary Completion

2023-05-30

Completion

2023-06-30

FDA Drug

Yes

FDA Device

Yes

Countries

• Bangladesh
• Pakistan
• Senegal
• Zambia

Study Locations