Tests a special diet added to anti-TNF drugs in Crohn's and colitis
Tests a special diet plus anti-TNF drugs in adults with Crohn's or colitis.
Key facts
- Who runs it
- IRCCS Ospedale San Raffaele
- Where
- Milan, ItalySee the site
- Trial code
- Registry title
- 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
- Status
- Recruiting
- People taking part
- 80 people, planned
- Started
- 22 May 2025
- Expected to end
- 1 Oct 2027
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- CDED (Crohn's Disease Exclusion Diet) in addition to anti-TNF therapy
- Anti-TNF Therapy
- Record updated
- 22 January 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with moderate-to-severe Crohn's disease or ulcerative colitis who are about to start anti-TNF therapy and are willing to follow the Crohn's Disease Exclusion Diet (CDED).
- Age
- 18 years or older
- Sex
- Men and women
- Disease stage
- Confirmed moderate-to-severe Crohn's disease or ulcerative colitis
- Earlier treatment
- Planned to start anti-TNF therapy. People who have used or are following CDED, or are on exclusive enteral nutrition (EEN), cannot join. People who had an intestinal resection cannot join.
Main reasons for not taking part
- Undetermined inflammatory bowel disease
- Conditions that could interfere with the diet, such as celiac disease or diabetes
- Body-mass index lower than 17 or greater than 30
- Previous intestinal resection
- Pregnant or breastfeeding women
The registry criteria, word for word
Show all 15 criteriaShow less
Who can take part
- 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)
Who cannot take part
- 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
- 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
- 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
Where in Italy
- IRCCS Ospedale San RaffaeleMilan, ItalyContact: Tommaso Lorenzo Parigi, MDTaking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The 2 groups in the trial
- Intervention groupTreatment being tested
Patients who accept participation and are randomized to receive dietary advice on the CDED diet will be included in the intervention group.
Treatment: CDED (Crohn's Disease Exclusion Diet) in addition to anti-TNF therapy
- Control groupExisting treatment, for comparison
The control group will receive only anti-TNF therapy as per the standard of care and guidelines recommendation
Treatment: Anti-TNF Therapy
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Impact of Diet on the Effectiveness of Anti-TNF Therapy in Inflammatory Bowel Disease: a Prospective, Randomized, Double Arm, Open-label Study
- Plain-language title
- Tests a special diet added to anti-TNF drugs in Crohn's and colitisGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 22 January 2026