NCT06896305

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

Impact of Diet on the Effectiveness of Anti-TNF Therapy in Inflammatory Bowel Disease: a Prospective, Randomized, Double Arm, Open-label Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: IRCCS Ospedale San Raffaele · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This is a prospective interventional, single-center, double-group, open-label study. Primary objective is to compare the efficacy of CDED in addition to anti-TNF therapy in active CD and UC versus anti-TNF therapy alone. Secondary objective are: * Endoscopic response * Endoscopic remission * Early and late efficacy and persistence of benefits * Biochemical response * Sonographic improvement * Tolerability and compliance to the Crohn's Disease ExclusionDiet (CDED) * Quality of life-Safety of the combination of biological therapy and CDED. The subjects considered are adult patients diagnosed with moderate-to-severe Crohn's disease or moderate-to-severe ulcerative colitis who are starting therapy with an approved anti-TNF agent (infliximab and adalimumab for both UC and CD, and golimumab only for UC).

Conditions

• Ulcerative Colitis (UC)
• Crohn Disease (CD)

Interventions

Type	Name	Description
COMBINATION_PRODUCT	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
DRUG	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.

Timeline

• Start date: 2025-05-22
• Primary completion: 2027-04-01
• Completion: 2027-10-01
• First posted: 2025-03-26
• Last updated: 2026-01-22

Locations

1 site across 1 country: Italy