60
Participants
Start Date
April 1, 2025
Primary Completion Date
April 1, 2027
Study Completion Date
October 1, 2027
CDED (Crohn's Disease Exclusion Diet) in addition to anti-TNF therapy
"Patients in the experimental group will receive professional dietary advice on how to adhere to CDED for 12 weeks, in addition to anti-TNF therapy while patients in the control group will receive only anti-TNF therapy for the entire duration of the study.~Diet adherence is completely voluntary and is not enforced in any way. CDED is divided into 3 phases, the first two, grouped as the induction phase, with 6 weeks of strict diet and 6 weeks to gradual food reintroduction, followed by 12 weeks of patients follow-up.~Five foods (chicken, eggs, potatoes, apple and bananas) are permitted at the start of the diet; the patient can then choose to consume a range of permitted foods at will, the variability of which increases after the first six weeks"
Anti-TNF Therapy
The control group will receive only anti-TNF therapy as per standard of care. This therapy is recommended by guidelines and is the cornerstone of treatment of Crohn's disease and ulcerative colitis.
IRCCS Ospedale San Raffaele, Milan
IRCCS Ospedale San Raffaele
OTHER