Ongoing Clinical Trials

The body of research examining therapeutic diets is growing. Many trials are still in progress, including several large multi-center trials (DIETOMICS-CD [CDED] and MELODY [IBD-AID]). The collection of ongoing clinical trials listed below has been cultivated from ClinicalTrials.gov.
Date Title Trial type Completed Diets Sponsor Summary Excerpt Trial
Apr 2018 Reverse Engineering of Exclusive Enteral Nutrition (RE-EEN) Interventional EEN Dale Lee This will be an open label, pilot study over 4 weeks in children with newly diagnosed Crohn's disease treated with a smoothie designed to emulate formulas used for exclusive enteral nutritional therapy. In place of formula, whole-foods based smoothie recipes and the food to create the smoothies will be given to each participant/family. The smoothies will be based upon the concept of reverse-engineering of exclusive enteral nutrition (RE-EEN). The smoothie recipes will involve whole foods that can be blenderized to liquid consistency. Similar to the formulas used for EEN, the smoothies will provide calories, protein, fat, and carbohydrates in a distribution to support growth and development. Patients will be evaluated for induction of remission and changes in microbiome. Open label, n=10
Jun 2017 Comparison of Partial and Exclusive Enteral Nutrition in the Treatment of Active Childhood-Onset Crohn's Disease Interventional EEN University Medical Centre Ljubljana The primary objective of this study is to determine the efficacy of a novel enteral nutrition (EN) protocol (delivering 75% of patient's caloric needs through EN) for induction of remission in patients with active childhood-onset Crohn's disease (CD) and compare it to the standard protocol with exclusive enteral nutrition (EEN). This novel approach allows patients to consume remaining calories (25%) from an antiinflammatory diet for CD (AID-CD). Randomized, open label n=50.
Jul 2016 Diet for Induction and Maintenance of Remission and Re-biosis in Crohn's Disease (DIETOMICS-CD) Interventional CDED, EEN, PEN Prof. Arie Levine The modified-Exclusive Enteral Nutrition (mEEN) is an open label randomized controlled pilot trial in mild to severe Crohn's Disease patients. The purpose of this study is to determine whether induction of remission and maintenance of remission can be achieved with a new dietary strategy that involves only 2 weeks of Exclusive Enteral Nutrition (EEN) with Modulen followed by an exclusion diet involving selected table foods, coupled with partial enteral nutrition for 24 weeks. This novel approach will be compared to the gold standard dietary regime involving 8 weeks of EEN followed by PEN with free diet. N=76
Jan 2015 Bacteria & Inflammation in the Gut (BIG) Study (BIG) Observational EEN NHS Greater Glasgow and Clyde EEN has previously been shown to induce changes in major bacterial metabolites and dominant bacterial species which are more profound in children that clinically improve. This study aims to determine whether it is possible to maintain these bacterial changes with prolonged supplementary enteral nutrition (SEN) while returning to normal diet and if this can reduce risk of subsequent relapse for children with CD. Observational, case control, n=200
Jul 2014 Cyclic Exclusive Enteral Nutrition as Maintenance Therapy for Pediatric Crohn’s Disease (CD-HOPE) Interventional EEN Assistance Publique - Hôpitaux de Paris There is convincing data indicating that EN is highly efficacious when given on an exclusive basis, while the use of partial EN is markedly less effective to induce remission in active Crohn's disease as compared to exclusive EN. Recently, it was suggested that exclusive EN has a dominant effect on the intestinal microbiota, which contributes to the induction of remission. There exists several strategies to maintain remission in children with CD, but there is no clear consensus on which maintenance treatment to follow. There are some indicators to believe that enteral nutritional therapy might play also a significant role as maintenance therapy for CD. Given the fact that many centers use a top-down approach with the introduction of immunosuppressors and/or biologics at/or shortly after diagnosis, the investigators wanted to test the possibility of a treatment option to efficiently maintain remission with less (or no) side effects based on enteral nutrition to avoid the early use of immunosuppressors.

Nutritional Therapy for IBD

Improving the Care of Patients with Crohn’s Disease and Ulcerative Colitis through Diet