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

Inclusion Criteria5

Participant is willing and able to give informed consent forparticipation in the study
Males or Females, Adults aged 18 years or older
Confirmed diagnosis of moderate-to-severe Crohn's disease orulcerative colitis
Patients who are planned to start anti-TNF therapy
Ability and willingness to comply with the Crohn's DiseaseExclusion Diet (CDED)

Exclusion Criteria10

Patients with undetermined inflammatory bowel disease
Patients with metabolic or gastrointestinal conditions that couldinterfere or are incompatible with the study intervention (e.i.celiac disease, diabetes etc)
Patients with a body-mass index lower than 17 or greater than30
Patients who previously underwent intestinal resectionirrespective of cause
Patients currently on exclusive enteral nutrition (EEN)
Patients who have previously used or are currently adhering toCDED
Pregnant or breastfeeding women
Patients with a history of severe allergic reactions orintolerance to any food recommended in CDED
Patients with significant comorbidities that may interfere withthe study or pose a risk to the participant
Inability or unwillingness to comply with study protocols orfollow-up schedules

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.