Efficacy of probiotic supplementation in preterm and small for gestational age infants: A multi-centre, placebo- controlled, individually-randomised trial (Probiotics in preterm and small for gestational infants, PROPS trial)
Study period: January 2025 to December 2027
Donor name: Bill & Melinda Gates Foundation through World Health Organization
Partners: Johns Hopkins University; World Health Organization
Project Description:
Background: Preterm and small-for-gestational-age (SGA) infants face higher mortality risks and are vulnerable to infections, malabsorption, growth failure, and other adverse health outcomes. Existing studies suggest that probiotics may offer health benefits for this group, but research is limited by small sample sizes and potential biases. The World Health Organization (WHO) and other global health bodies have emphasized the need for high-quality trials to generate robust evidence.
Objective: The overall aim of the trial is to assess the effect of probiotic supplementation on mortality, morbidity, and growth in preterm or term SGA infants in the first six months of life. For preterm infants, the primary objective is to assess the effectiveness of probiotic supplementation on mortality from enrolment to six months of age. For term SGA infants, the primary objective is to assess the effectiveness of probiotic supplementation on underweight-free survival over the same period.
Methods: We are conducting a double-blind, individually randomized, placebo-controlled, parallel-group clinical trial in hospitals across Bangladesh, Ethiopia, Kenya, Nigeria, and Pakistan, with follow-up through home visits. In Bangladesh, we are recruiting infants at Sylhet Osmani Medical College Hospital and Sylhet Women’s Medical College Hospital. We are enrolling a total of 14,000 preterm and term SGA infants within 48 hours of birth, including 3,100 from Bangladesh. Supplementation begins at enrollment and continues for 28 days. The intervention group receives probiotics, while the control group receives a placebo. Our independent assessment team conducts outcome assessments every four weeks until the infants reach six months of age.
Significance: The findings from this trial will contribute to updating WHO recommendations and developing new guidelines for probiotic supplementation in preterm and SGA infants. This will inform policy and practice, improving evidence of certainty on critical outcomes and optimizing probiotic use in high-burden low-resource settings.