Exclusive Enteral Nutrition and Corticosteroids Therapy in Crohn's Disease (EENCD)
Status:
Terminated
Trial end date:
2019-11-01
Target enrollment:
Participant gender:
Summary
This study evaluates the effect of Exclusive Enteral Nutrition (EEN) in addition to different
regimes of corticosteroid (CS) therapy (Prednisone) compared to CS alone in adults
participants with active Crohn's Disease, on symptoms and inflammation after 6 weeks of
treatment. Participants will be randomized to three treatment arms: standard CS, standard CS
with EEN, short course CS with EEN. Participants will be assessed through questionnaires for
gut symptoms, quality of life, mood changes and dietary patterns and potential mechanisms
will be investigated by collecting stool samples for characterization of gut bacterial
profiles, collection of blood to determine inflammatory markers and evaluation of gut
motility before and after treatment. The investigators hypothesize that six weeks of EEN with
CS will be more effective than CS alone in inducing clinical remission in patients with
active CD, as well as leading to beneficial changes in the composition and/or metabolic
activity of the intestinal microbiota, gastrointestinal transit and inflammatory burden.
Furthermore, six weeks of EEN in addition to a short course of CS will have similar efficacy
than EEN with standard course of CS and reduced number of adverse events.