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Otiti, Mary Iwaret, June, Micah, K’Oloo, Alloys, Chomba, Miriam, Dodd, James, Luo, Yutian, Kiu, Raymond, Hall, Lindsay 
ORCID: https://orcid.org/0000-0001-8938-5709, Wang, Duolao, Otieno, Kephas, Kariuki, Simon, ter Kuile, Feiko O. and Allen, Stephen
(2026)
Pro/synbiotics reduce systemic inflammation and improve gut health in Kenyan infants: An open label, randomized, 4-arm, phase II trial.
Cell Reports Medicine, 7 (6).
ISSN 2666-3791
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Abstract
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.
| Item Type: | Article |
|---|---|
| Additional Information: | Publisher Copyright: © 2026 The Authors. Published by Elsevier Inc. This is an open access article under the CC BY-NC license. http://creativecommons.org/licenses/by-nc/4.0/ |
| Uncontrolled Keywords: | africa,biomarker,children,clinical trial,environmental enteric dysfunction,growth hormones,probiotic,synbiotic,systemic inflammation,general medicine,general biochemistry,genetics and molecular biology ,/dk/atira/pure/subjectarea/asjc/2700/2700 |
| Faculty \ School: | Faculty of Medicine and Health Sciences > Norwich Medical School |
| UEA Research Groups: | Faculty of Medicine and Health Sciences > Research Centres > Metabolic Health |
| Related URLs: | |
| Depositing User: | LivePure Connector |
| Date Deposited: | 06 Aug 2026 13:56 |
| Last Modified: | 07 Aug 2026 08:35 |
| URI: | https://ueaeprints.uea.ac.uk/id/eprint/104025 |
| DOI: | 10.1016/j.xcrm.2026.102834 |
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