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

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.

Inclusion Criteria:Women over the age of 18 years in the second trimester of pregnancy, living in defined geographical areas of Bangladesh, Pakistan, Senegal and Zambia, where it can be assumed that environmental enteropathy is universal.Exclusion CriteriaPotential participants will not be enrolled if they:have had diarrhoea, defined as the passage of three or more loose stools per 24 hours, in the preceding 14 days;have taken antibiotics or probiotics in the preceding 14 days;have taken non-steroidal anti-inflammatory drugs in the preceding 14 days;have haemoglobin concentration <8g/dl;have any illness which in the opinion of the investigator will complicate assessment of safety or efficacy;have any gastrointestinal contraindication to ingestion of a capsule (known or suspected gastrointestinal obstruction, stricture, fistula, gastroparesis, or any swallowing disorder);have a plan to leave the study area within the follow-up period;but may be enrolled if/when these disqualifiers have expired.