Phase II Trial of Oral Vancomycin Followed by VE818 Probiotic to Reduce Gut Pathogens and Improve Gut Health in Pregnant Women with Environmental Enteric Dysfunction

What this Trial Is About

Environmental Enteric Dysfunction EED is a gut condition that affects many children, leading to malnutrition, poor brain development, stunted growth, vaccine failure, and infections. This trial studies pregnant women to see if a probiotic treatment can improve gut health by reducing harmful bacteria and inflammation. The research focuses on whether giving an antibiotic followed by a probiotic can reduce certain bacterial pathogens in pregnant women colonized by these bacteria. The study enrolls 144 pregnant women in their second trimester from communities in Pakistan and other countries. Participants will be randomly assigned to three groups one receiving oral vancomycin antibiotic followed by the probiotic VE818, another receiving vancomycin followed by a placebo, and an observation-only group with no intervention. Vancomycin will be given three times daily for 5 days, followed by a 1-day break, then daily probiotic or placebo for 14 days. The study is double-blinded and involves careful monitoring throughout pregnancy. Participants will undergo various tests including blood, urine, stool, saliva, and vaginal swabs collected before, during, and after treatment. A special non-invasive capsule called CapScan will collect gut samples. Researchers will measure changes in harmful bacteria counts using advanced lab techniques, track pregnancy progress with ultrasounds, and follow mothers and babies up to one month after birth. Daily visits will monitor adherence and any side effects, ensuring detailed data collection during the study period.

Maternal Probiotic Intervention to Improve Gut Health-Trial II-Pakistan