RecruitingNot ApplicableNCT06896305

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

Sponsor

IRCCS Ospedale San Raffaele

Enrollment

80 participants

Start Date

May 22, 2025

Study Type

INTERVENTIONAL

Conditions

Ulcerative Colitis (UC)Crohn Disease (CD)

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding a specific anti-inflammatory diet (called the Crohn's Disease Exclusion Diet, or CDED) to standard biologic drug treatment (anti-TNF therapy) leads to better disease control in people with moderate to severe Crohn's disease or ulcerative colitis compared to medication alone. The idea is that what you eat can significantly affect gut inflammation, and combining dietary changes with medication may produce better and longer-lasting results. **You may be eligible if...** - You are 18 years or older - You have a confirmed diagnosis of moderate to severe Crohn's disease or ulcerative colitis - You are about to start anti-TNF therapy (such as infliximab or adalimumab) for the first time or after a break - You are willing and able to follow the Crohn's Disease Exclusion Diet during the study **You may NOT be eligible if...** - You are already on anti-TNF therapy - You have previously failed multiple biologic medications - You have severe malnutrition or are unable to eat normally - You are pregnant or breastfeeding - You have had major bowel surgery or have a bowel ostomy - You are unable or unwilling to follow the required diet Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

COMBINATION_PRODUCTCDED (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

DRUGAnti-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.