Researchers from the Johns Hopkins Bloomberg School of Public Health’s Department of International Health (IH) are assessing the role of probiotics in promoting child growth and survival in low- and middle-income countries (LMIC).
The IH faculty are collaborating with the World Health Organisation (WHO) and other partners in sub-Saharan Africa and Asia on two new studies.
The studies are designed to help advance our understanding of probiotics in improving newborn health and use at scale to treat children in LMIC settings.
The first study, dubbed Probiotics in Preterm and Small for Gestational Age Infants (PROPS), is a randomised controlled trial (RCT) conducted in five countries, for three years.
In the study, a newly developed probiotic supplement will be tested for reducing mortality and improving growth among premature and low-birthweight newborns in LMICs.
The new probiotic supplement is a combination of two live bacteria, Bifidobacterium longum subsp. Infantis (B. Infantis) and Lactobacillus rhamnosus GG (L. rhamnosus GG).
The two bacteria showed potential in preventing harmful bacteria from developing through the gut, and the combination is expected to provide additional protection to newborns.
The study will enrol 14,000 preterm and small for gestational age (SGA) newborns in urban, peri-urban, and rural areas of Bangladesh, Ethiopia, Kenya, Nigeria, and Pakistan.
The study will begin enrolment in late 2025, with IH assistant scientist Kayur Mehta leading pre-trial activities, including the development of study protocols.
Mehta will develop all study materials and protocols for each of the sites with the help of IH faculty senior research associate Melissa Higdon and research associate Sheri Morgan.
The team will also ensure that the new probiotic supplement is ready for regulatory approval and fulfils technical requirements for Good Clinical Practice.
Mehta said: “Preterm and SGA infants have a 2- to 10-fold higher risk of mortality than infants born at term and with normal birth weight, and are particularly vulnerable to infection, malabsorption, necrotising enterocolitis, difficulty feeding, and growth failure.
“While numerous trials conducted in the last decade have reported that probiotics can improve short- and long-term mortality, necrotising enterocolitis and sepsis rates, and growth and neurodevelopment in these at-risk infants, most trials were small with a high to moderate risk of bias.”
WHO’s Department of Maternal, Newborn, Child and Adolescent Health and Ageing will coordinate the study, along with St Paul’s Hospital Millennium Medical College, University of Ibadan and University College Hospital, and Aga Khan University, Pakistan.
The researchers will also develop the first safety framework for probiotic use in children and evaluate how health systems can scale up use in low- and middle-income settings.
