The Leona M. and Harry B. Helmsley Charitable Trust Awards $4.7 Million to Fund Three Studies on Dietary Interventions for Crohn's Disease
New York, NY — The Leona M. and Harry B. Helmsley Charitable Trust announced today it is awarding three grants to fund separate studies to inform evidence-based recommendations on ways that dietary interventions might prevent or treat Crohn’s disease. The grants, totaling $4,698,691, further advance Helmsley’s mission to improve the lives of people living with Crohn’s disease.
The Combination therapy of diet with biologicals for Crohn’s disease (OATS) study and the Inflammatory Bowel Disease Mediterranean Diet (IBDMED) project are collaborations between the Prevention and Disease Management teams of Helmsley’s Crohn’s Disease Program, while the Preventing IBD ONset in Individuals at Risk (PIONIR) trial is funded as part of the Prevention portfolio.
“Previous studies strongly suggest that dietary interventions may be beneficial in Crohn’s disease, but clear evidence-based recommendations are lacking,” said Paul Scholl, Program Director of the Helmsley Charitable Trust Crohn’s Disease Program. “By directly evaluating the effects of specific dietary regimens in preventing and treating Crohn’s disease, these new studies will provide much needed data that can guide future research and inform dietary guidelines for people living with this disease.”
The OATS study will investigate the safety and efficacy of the Food influence on the Intestinal microbioTa (FIT) diet as an add-on therapy during the induction and maintenance phases of biologic drug therapies in 144 patients with active Crohn’s disease. If successful, the OATS study will demonstrate how a safe, non-invasive, tolerable, and flexible diet can be used in conjunction with patients’ standard biologic medications to facilitate the induction and maintenance of remission in Crohn’s disease patients.
Helmsley is awarding $1.9 million for the OATS project that will be conducted over three years by Katholieke Universiteit Leuven (KU Leuven), the largest university in Belgium and one of the top European Commission-funded institutes of higher education. “The support from Helmsley to KU Leuven to conduct the OATS study is a dream come true,” said Dr. João Sabino, Gastroenterologist and Assistant Professor of Medicine at KU Leuven, and Principal Investigator for this study. “After developing a diet with positive effects on reducing intestinal inflammation, I was keen to start a dietary intervention trial specifically targeting patients with Crohn’s disease. With the OATS study, we want to prove that an anti-inflammatory diet should be added to the standard of care regimen for patients with Crohn’s disease.”
The IBDMED study aims to develop a globally-tested nutritional education program to improve adherence to the Mediterranean Diet (MED) in patients with early Crohn’s disease. Researchers will seek to evaluate the effect of the IBDMED program on patients with newly diagnosed Crohn’s disease in India and compare its effects to the same intervention performed in Israel. The IBDMED program also educates patients on how to implement and incorporate MED principles in their lifestyles by providing online dietician support, information, tips, cooking methods, recipes, shopping lists, personalized weekly reports, and monitoring of physical activity with fitness trackers...