The Leona M. and Harry B. Helmsley Charitable Trust has awarded grants to 3 studies in Crohn disease that will be conducted to inform evidence-based recommendations on the optimal use of dietary interventions to treat or potentially prevent the inflammatory bowel disease.
The grants, which total $4,698,691, will specifically support the COmbinAtion therapy of diet with biologicalS for Crohn disease (OATS), Inflammatory Bowel Disease Mediterranean Diet (IBDMED), and Preventing IBD Onset in Individuals at Risk (PIONIR) trials. Although existing evidence “strongly suggests that dietary interventions may be beneficial in Crohn disease…clear evidence-based recommendations are lacking,” according to Paul Scholl, program director of the Helmsley Charitable Trust Crohn Disease Program. Insights from the respective studies are expected to shed light on the efficacy of the dietary regimens tested and provide the basis for dietary guidelines for individuals with Crohn disease.
Regarding the dietary regimens to be evaluated, the OATS study will test 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 therapy in 144 patients with active Crohn disease. The OATS trial is supported by a $1.9 million grant, and will be conducted at the largest university in Belgium, Katholieke Universiteit Leuven (KU Leuven), over a 3-year study period.
In the IBDMED study, investigators will assess the effect of the IBDMED nutritional education program on the Mediterranean Diet in patients with early Crohn disease. The researchers will compare the program’s actionability in patients in India with that of patients in Israel; however, no target enrollment number has been set. The IBDMED trial is backed by a $1.4 million grant.
The PIONIR study is a randomized controlled trial that will evaluate the “Tasty & Healthy” dietary approach in the induction and remission maintenance of Crohn disease. PIONIR will enroll a presently unspecified number of individuals from another Helmsley-funded study, the Genetic, Environmental, and Microbial (GEM) Project, considered to be at high risk of developing Crohn disease.
PIONIR investigators will study the “Tasty & Healthy” diet’s clinical effect on risk factors including microbiome composition, inflammation, gut permeability, serological markers, and proteomic profiles. A $1.3 million grant will fund this endeavor.
The Leona M. and Harry B. Helmsley Charitable Trust has not specified when patient enrollment for each of the 3 studies will begin.
Helmsley Awards $4.7 Million To Fund Three Studies On Dietary Interventions For Crohn’s Disease. News Release. Helmsley. November 16, 2020. Accessed December 2, 2020.