Study of Probiotic VE818 to Lower Harmful Gut Bacteria and Improve Gut Health in Pregnant Women with Environmental Enteric Dysfunction in Bangladesh, Pakistan, Zambia, and Burkina Faso

What this Trial Is About

Environmental Enteric Dysfunction EED is a condition affecting the gut, causing changes in gut lining and immune response, leading to malnutrition, poor neurological development, stunted growth, oral vaccine failure, and infections. This condition is thought to contribute to 40% of childhood stunting. Research shows that stunting often begins before birth due to poor maternal health, especially in pregnancy, where EED in mothers causes inflammation and poor nutrient availability affecting fetal growth. This trial studies if taking oral vancomycin followed by a probiotic called VE818 can reduce harmful gut bacteria in pregnant women who carry specific bacterial pathogens. Women will be randomly assigned to one of three groups vancomycin plus VE818, vancomycin plus placebo, or observation only. All women will receive standard multiple micronutrient supplements during pregnancy. The study is done in multiple countries and lasts through pregnancy until one month after birth. Participants will have samples collected including blood, saliva, urine, stool, vaginal swabs, and intestinal samples using a non-invasive capsule device. Researchers will monitor changes in specific gut bacteria, inflammation markers, gut permeability, and microbiome diversity at several time points during pregnancy and after birth. Health outcomes of mother and infant will be followed to assess the effects of the probiotic treatment. The main measurement is the change in harmful bacteria counts two weeks after completing the 14-day treatment course.

Maternal Probiotic Intervention to Improve Gut Health - Trial II - Burkina Faso (MPIGH-II)