Dr. Margaret Kosek, assistant professor at the Johns Hopkins Bloomberg School of Public Health, and Dr. Richard Oberhelman, professor and chair in the Department of Global Community Health and Behavioral Sciences at the Tulane School of Public Health and Tropical Medicine, have been awarded a five-year $3.3 million grant to study the use of probiotics in treating pediatric diarrhea in Peru. The grant has been awarded by the National Institute of Diabetes and Digestive and Kidney Diseases. Dr. Kosek and Dr. Oberhelman will serve as co-principal investigators for this grant.
The digestive system is home to hundreds of different types of bacteria. Probiotics are bacteria commonly found in yogurt and available in supplements that can often help keep the intestines healthy and aid in digestive issues.
Pediatric diarrhea is an enduring problem in low-income countries, where it is the second leading cause of death in children aged 1 to 5. It also leads to stunted growth and chronic health conditions. The clinical trial will look at whether children who are treated with Lactobacillus reuteri 17938, a specific probiotic product, have shorter durations of diarrhea and improved growth.
Parents of children aged one month to two years will be invited to participate in the trial, which will be conducted in Santa Clara, Peru, a community located about 15 miles from Iquitos in the Amazon. The population of Santa Clara is primarily native Amazonian Amerindian in ancestry, and children in this community have high rates of diarrhea. Dr. Kosek has an established clinic and research team in Santa Clara and both researchers have worked extensively on diarrheal issues in Peru for many years.
The study will consist of two phases, with a smaller group of 60 infants enrolled during the phase 1 safety study modeled after similar phase 1 studies in adults and older children, and a larger group of more than 400 children enrolled over the course of two years in a phase 2 efficacy study. Once enrolled, participating children will receive a 5-day course of the probiotic at every incidence of diarrhea for the next two years. The study will not only examine the impact of the probiotic on duration of diarrhea, but will also provide important new information about the effect of probiotics on gut function and on the types of bacteria that colonize the gut of children in this community, also known as the “microbiome”.
“We are very interested to see how L. reuteri 17938 will impact gut function,” said Dr. Oberhelman. “There is a lot of interest in this area right now, looking at just how the gut flora might improve disease. It’s the kind of study we’ve wanted to do but we have newer technology now will aid us in this research.”