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
Feb 2019 The MELODY Trial: Modulating Early Life Microbiome Through Dietary Intervention in Crohn's Disease
Interventional IBD-AID Icahn School of Medicine at Mount Sinai The goal of this study is to prospectively test the hypothesis that a non-invasive dietary intervention during the last trimester of pregnancy could beneficially shift the microbiome of CD and UC patients and their babies, hereby promoting a healthier immune system during a critical time of the immune system development. Particularly, the study team will test whether favorable diet-driven changes in the microbiome can lead to a reduced risk of postpartum relapse and lower gut inflammation in the offspring. The study design is a three-arm, prospective, pre-post intervention trial. Crohn's Disease (CD) patients at 27-29 weeks of pregnancy will self-select to Arm 1 or Arm 2. Controls will be in Arm 3. Arm 1 (diet-CD): 8-10 weeks of dietary intervention (n=66) Arm 2 (no-diet-CD): usual diet with no intervention (n=66) Arm 3 (no-diet-control): unaffected controls at the same gestational stage will follow their usual diet and no intervention (n=66). This study has been updated to include mothers with UC in addition to mothers with CD.

Nutritional Therapy for IBD

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


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