Impact of Exclusion Diet in Addition to Anti-TNF Therapy in Crohn's Disease and Ulcerative Colitis: a Prospective, Randomized, Double-arm, Open-label Study

This clinical study protocol aims to prospectively compare the efficacy of standard therapy with anti-TNF agents combined with the Crohn's Disease Exclusion Diet (CDED) versus anti-TNF therapy alone in adult patients with active Crohn's disease or ulcerative colitis. The study will involve patients starting therapy with anti-TNF agents due to active Crohn's disease or ulcerative colitis as per standard clinical practice and in accordance with European (ECCO) guidelines. One group will receive standard medical therapy only, the other will additionally receive dietary advice on how to adhere on a specific exclusion diet, the CDED. By prospectively evaluating the impact of this combined approach, the study seeks to provide evidence on whether CDED can improve response to treatment and therefore improve quality of life for patients with Crohn's disease and ulcerative colitis.

NCT Number	NCT06896305
Lead Sponsor	IRCCS Ospedale San Raffaele
Conditions	Ulcerative Colitis (UC), Crohn Disease (CD)
Enrollment	80 participants
Start Date	2025-05-22
Primary Completion	2027-04-01 (estimated)
Study Completion	2027-10-01 (estimated)
Updated on ClinicalTrials.gov	2026-01-22