Pro/synbiotics reduce systemic inflammation and improve gut health in Kenyan infants: an open label, randomised, 4-arm, phase II trial

Environmental enteric dysfunction, universal in young children exposed to poor sanitation and hygiene, impairs growth and development through malabsorption and as a driver of chronic systemic inflammation (CSI). In an open-label, randomized, four-arm, phase II clinical trial, infants with birthweight >=2000g in Homa Bay County, western Kenya receive live, multi-strain Bifidobacterium spp. and Lactobacillaceae pro/synbiotics from 0-6 months. CSI (plasma >=1-acid glycoprotein >1g/L) at age 6 months (primary outcome) occurs in 60/138 (43%) controls versus 4/144 (3%; risk ratio (RR) 0.06, 95% CI 0.02-0.17) infants in the Labinic synbiotic, 3/132 (2%; RR=0.05, 0.02-0.16) in the Lab4b synbiotic, and 3/141 (2%; RR=0.05, 0.02-0.15) in the Lab4b probiotic arm. Biomarkers of gut health and growth hormones also improve; no serious adverse events are attributed to the interventions. Pro/synbiotics safely and markedly reduce CSI in a highly disadvantaged population, warranting investigation of health impacts. The trial is registered on https://pactr.samrc.ac.za; Identifier: PACTR202003893276712