Condition: Environmental Enteric Dysfunction (EED) · Stunting · Sponsor: Aga Khan University
Burden: Environmental Enteric Dysfunction (EED) is an enteropathic condition characterised by altered gut permeability, infiltration of immune cells, and changes in villous architecture and cell differentiation. EED is a major reason of malnourishment, poor neurological development, stunting, oral vaccine failure, and infection. It is believed that EED is responsible for 40% of all childhood stunting. Relevance: This trial aims to investigate the concept that a probiotic or live biotherapeutic product, capable of improving gut microbiota composition, can also displace enteropathogens and reduce biomarkers of intestinal inflammation, thereby promoting gut health. This will restore healthy microbial signalling to the host epithelium, ameliorate barrier function through secretion of mucus and antimicrobial factors, and improve nutrient availability. Objectives: The primary objective is to assess if administration of oral vancomycin followed by VE818 to pregnant women colonised with at least 2 out of 11 selected bacterial enteropathogens results in a significant change in the mean count of these organisms between the baseline and 2 weeks after completion of the intervention (Study Day 35d +2), compared to oral vancomycin followed by placebo. Methods: Pregnant women will be recruited from the community of Matiari in Pakistan. The study population will be women aged 18 years or older in the first trimester or early second trimester of pregnancy. Study procedures will be explaine…
This description comes directly from the study's public registry record.
Asad Ali Syed, MPH · +92 2134864233 · asad.ali@aku.edu
Sheraz Ahmed, Masters · +92222760394 · sheraz.ahmed@aku.edu
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| Mother and Child Health Research and Training Center, AKU | Matiari, Sindh, Pakistan | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07207434