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

Official title

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

Overview

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).

Interventions

• 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 o
• 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.

Primary outcome measures

• Efficacy of CDED in addition to anti-TNF therapy in active CD and UC versus anti-TNF therapy [Time frame: Week 14/16]

Secondary outcome measures (7)

• Endoscopic response and endoscopic remission [Time frame: Week 24]
• Early and late efficacy and persistence of benefits [Time frame: Week 6/ Week 24]
• Biochemical response [Time frame: Week 6, 14/16, 24]
• Sonographic improvement [Time frame: Week 6, 14/16, 24]
• Tolerability and compliance to the Crohn's Disease Exclusion Diet (CDED) [Time frame: Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12]
• Quality of life assessed using the Short-IBD-Q questionnaire [Time frame: Week 14/16, week 24]
• Safety of the combination of biological therapy and CDED [Time frame: From baseline until the end of the study]

Eligibility criteria

Inclusion criteria

• 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 criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Italy · 1 center

• IRCCS Ospedale San Raffaele — Milan

Identifiers

NCT: NCT06896305 · IDEA-TNF

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗