Pro/synbiotics reduce systemic inflammation and improve gut health in Kenyan infants: An open label, randomized, 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 ≥2000 g in Homa Bay County, western Kenya receive live, multi-strain Bifidobacterium spp. and Lactobacillaceae pro/synbiotics from 0 to 6 months. CSI (plasma α₁-acid glycoprotein >1 g/L) at age 6 months (primary outcome) occurs in 60/138 (43%) controls versus 4/144 (3%; risk ratio [RR], 0.06; 95% confidence interval [CI], 0.02–0.17) infants in the Labinic synbiotic arm, 3/132 (2%; RR = 0.05; 95% CI, 0.02–0.16) in the Lab4b synbiotic arm, and 3/141 (2%; RR, 0.05; 95% CI, 0.02–0.15) in the Lab4b probiotic arm. Biomarkers of gut health and growth hormones also improve, and no serious adverse events are attributed to the interventions. Pro/synbiotics safely and markedly reduce CSI in a highly disadvantaged population, warranting further investigation of health impacts. The trial is registered at https://pactr.samrc.ac.za; identifier: PACTR202003893276712.