NCT06896305Recruiting
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
Source: ClinicalTrials.gov · Last updated 22 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 2 Feb 2025
- Start date
- 22 May 2025
- Primary completion date
- 1 Apr 2027
- Lead sponsor
- IRCCS Ospedale San Raffaele
- Diseases
- Crohn's disease, Ulcerative colitis
- NCT number
- NCT06896305
What you commit to
- Study type: Interventional
- Planned participants: 80
- From 22 May 2025 to the primary completion date, 1 Apr 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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 history of severe allergic reactions orintolerance to any food recommended in CDED
Other
- Patients with a body-mass index lower than 17 or greater than30
- Pregnant or breastfeeding women
- 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
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| IRCCS Ospedale San Raffaele Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.