The pilot, open-label study is funded by Gates Foundation, Child Relief International and the Thrasher Research Fund.
SOMERVILLE, Mass. – OpenBiome is pleased to announce its inaugural global health study, which will evaluate microbial therapy as a treatment for pediatric severe acute malnutrition. This study, the first of its kind, will be supported by a grant of $135,000 from the Bill & Melinda Gates Foundation, a $120,000 grant from Child Relief International, and $23,000 from the Thrasher Research Fund.
Severe acute malnutrition (SAM) is a life-threatening condition affecting over 20 million children under the age of 5 worldwide that causes patients to be severely underweight, stunted in growth, or have swelling in their extremities – and causes at least 1 million deaths each year. Over 35% of SAM cases do not respond to the standard treatment of nutrient-enhanced foods.
Recent pre-clinical studies have demonstrated that the gut microbiome may play a role in how children with SAM respond to treatment. These findings suggest that patients who are unresponsive to standard treatments may be unable to properly absorb nutrients due to the makeup of their gut microbiome. By investigating fecal microbiota transplantation (FMT) as a treatment option, this study will explore the possibility of modifying the microbiome of children with non-responsive SAM to aid in their recovery in conjunction with therapeutic nutrition.
“As we learn more about the many ways that the gut microbiome affects human health, we are discovering that there is, in particular, immense potential for FMT as a treatment tool for some of the greatest health challenges faced by children in low-resource settings,” said Majdi Osman, MD MPH, OpenBiome’s Clinical Program Director, Director of the Global Health Microbiome Initiative, and the principal investigator for this study,
OpenBiome plans to explore the therapeutic potential of FMT and other microbiome-derived therapies for other diseases that primarily affect patients in low- and middle-income countries, including typhoid and a range of enteric diseases, through its new Global Health Microbiome Initiative.
“We are eager to bring our experience in clinical research on the microbiome to areas that traditionally go underserved,” said Carolyn Edelstein, OpenBiome’s Executive Director. “We are grateful for the support of the Bill & Melinda Gates Foundation, Child Relief International and the Thrasher Research Fund as we continue our mission to catalyze research on the human microbiome by setting our sights on the development of microbial therapies that target these resource gaps.”
OpenBiome is the first public stool bank, founded to expand safe access to fecal transplantation for patients with recurrent C. difficile infection and to catalyze research on the microbiome’s role in human health. OpenBiome provides clinicians with rigorously screened, ready-to-use stool preparations and supports researchers with a suite of tools to discover how gut bacteria might treat diseases beyond C. difficile. Since 2013, OpenBiome has partnered with over 1,000 healthcare institutions across all 50 states and 7 countries to deliver over 35,000 treatments for recurrent C. difficile. Its research portfolio includes 36% of active U.S. trials exploring the use of fecal transplants to treat disease. For more information, visit http://www.openbiome.org.