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

Официальное название

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

Обзор

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.

Подробное описание

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).

Вмешательства

• Комбинированный продукт 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
• Препарат 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.

Первичные конечные точки

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

Вторичные конечные точки (7)

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

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Италия · 1 центр

• IRCCS Ospedale San Raffaele — Milan

Идентификаторы

NCT: NCT06896305 · IDEA-TNF

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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