The trial demonstrated that 80% of patients on the combined therapy approach achieved remission from Crohn’s disease at week six, versus 73.5% of patients taking exclusively enteral nutrition; at week 12, the results were 70% and 42.5%, respectively.
“This is a breakthrough,” said Professor Arie Levine, the leading Paediatric Gastroenterologist at Wolfson Medical Center in Israel, who designed the Crohn’s Disease Exclusion Diet (CDED) and researched it in partnership with Nestlé Health Science. “The disruptive clinical data changes our view regarding the future treatment of Crohn’s disease. This highly effective treatment has no side effects and will be accessible to all healthcare professionals.”
Nestlé Health Science has used the results of the study to create ModuLife, a platform to support a complete dietary management solution for patients with Crohn’s disease. Patients benefit from the essential nutrients of Modulen IBD, the partial enteral nutrition formula, while also enjoying whole foods and using an online platform to access recipes and meals plans, track diet adherence and wellbeing, and receive diet guidance from CDED specialists. Because ModuLife is physician-supervised, patients and their healthcare providers can collaborate to ensure that patients receive ongoing support and maintain habits that prolong the remission of their disease.
“ModuLife is a paradigm change for how Crohn’s disease patients and healthcare providers manage the disease,” said Greg Behar, CEO of Nestlé Health Science. “It provides healthcare professionals with a dietary approach backed by science and it provides patients with support programs as they make the changes to their diet. It is an excellent example of Nestlé Health Science’s dedication to advancing the role of nutrition through science-based innovation.”
The results from the randomized controlled trial, supporting the CDED therapy, are being released in the August 2019 edition of Gastroenterology (Levine, Volume 157, Issue 2, 440- 450.e8). It found that the novel CDED, coupled with partial enteral nutrition, was better tolerated than exclusive enteral nutrition and demonstrated superior sustained remission and reduction in inflammation within 12 weeks.
These new data further demonstrate the benefits of the CDED therapy on remission rates, gut microbiota and tolerance, paralleled to the exclusive enteral nutrition, a proven dietary intervention and standard treatment for Crohn’s disease.
The CDED is a novel dietary therapy that combines a whole food diet with partial enteral nutrition (in the randomized trial Modulen IBD was used). It is designed to reduce the exposure to dietary components hypothesized to negatively affect the microbiome, intestinal barrier and innate immunity. It therefore helps reduce the components assumed to increase the risk of developing Crohn’s disease and increasing its severity. It does so without sacrificing the possibility of enjoying whole foods, which makes it highly acceptable for patients.
Furthermore, the CDED is based on three distinct phases, which help expand the choices of “allowed” foods as the diet progresses through time, with the proportion of Modulen IBD reduced after stage 1 from 50% to just 25% of total energy.
“The Crohn’s Disease Exclusion Diet addresses the environmental factors that trigger the disease,” said Levine.
There is no cure for Crohn’s disease, and most patients are typically reliant on anti-inflammatory drugs and surgical interventions to manage symptoms. These treatments can be expensive, both for the patient and health care providers coping with disease incidence on the rise. ModuLife reduces this dependency, by offering a treatment solution that can be used prior to or in addition to medical treatments, meaning lower costs to patients and reduced financial strain on health care systems.