Global WACh

August 25, 2025

Researchers support new trial to evaluate the effects of probiotics in highly vulnerable infants

Preterm and small for gestational age (SGA) infants have a significantly higher risk of mortality and morbidity than term infants or those born with normal birth weight in low- and middle-income countries. However, improvements in outcomes in these highly vulnerable populations have been slow worldwide due to the complexity of medical management of small and vulnerable infants. In recent years, small-scale clinical trials conducted across a variety of settings have shown that probiotic supplementation can improve short- and long-term outcomes, including reducing rates of sepsis and necrotizing enterocolitis and improving growth and neurodevelopment. However, there is limited data on use of probiotics in preterm and SGA populations that is needed to inform future policy  and practice.

To help expand the evidence base of probiotic supplementation in preterm and SGA infants, Global WACh researchers are supporting the newly launched “Efficacy of probiotic supplementation in preterm and small for gestational age infants: A multi-centre, placebo-controlled, individually-randomised trial (PROPS Trial)” sponsored by the WHO Newborn and Child Health and Development Unit, coordinated by Johns Hopkins University, and funded by the Gates Foundation.  The trial will assess the effect of probiotic supplementation on mortality, morbidity, and growth in 14,000 enrolled preterm or term SGA infants in the first six months of life in five South Asian (Bangladesh, Pakistan) and Sub-Saharan African (Ethiopia, Kenya, Nigeria) countries with high rates of preterm birth and malnutrition among infants. Implementing partners include:

  • Bangladesh: Projahnmo Research Foundation
  • Ethiopia: St Paul’s Hospital Millennium Medical College, Armauer Hansen Research Institute, Children’s Hospital of Philadelphia Research Institute
  • Kenya: Kenya Medical Research Institute, University of Washington
  • Nigeria: University of Ibadan and University College Hospital, College of Medicine, Stanford University
  • Pakistan: Aga Khan University

The trial results will play a crucial role in informing policies and clinical practice guidelines for probiotic supplementation in preterm and SGA infants at the global, national, and facility levels. It will strengthen the current understanding of optimal probiotic species and strains, dosing, and the duration of supplementation that offer the greatest benefit to this population in low-to-middle income countries. Strong, reliable evidence that demonstrates significant benefits for preterm and SGA infants may lead to updated recommendations by the World Health Organization (WHO). Ultimately, stronger recommendations could help countries strengthen health systems, improve health outcomes, and work towards achieving target-related goals.