Adding the Crohn's Disease Exclusion Diet to anti-TNF treatment for Crohn's disease and ulcerative colitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, randomized, two-arm, open-label study at a single center comparing anti‑TNF therapy alone to anti‑TNF therapy combined with the Crohn's Disease Exclusion Diet (CDED) in adults with moderate-to-severe Crohn's disease or ulcerative colitis. Adults who are starting approved anti‑TNF agents per standard practice will be randomized to receive standard medical therapy or the same therapy plus dietary coaching to follow CDED. Outcomes include clinical response and remission, endoscopic and sonographic measures, biochemical markers, treatment persistence, tolerability and quality of life. The study will also track adherence to the diet and safety of combining CDED with biologic therapy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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

Exclusion Criteria:

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

Where it's running

• IRCCS Ospedale San Raffaele
  Milan, Michigan, Italy Recruiting

Study contacts

• Principal investigator: Tommaso Lorenzo Parigi, MD — IRCCS Ospedale San Raffaele
• Study coordinator: Tommaso Lorenzo Parigi, MD
• Email: parigi.tommaso@hsr.it
• Phone: +39 02 2643 2756

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• CEDUR — German inflammatory bowel disease registry

  This registry collects real-world health and treatment information from adults with Crohn's disease, ulcerative colitis, or indeterminate colitis in Germany to see how care, effectiveness, safety, and costs play out in routine practice.

  Recruiting ImmunoRegister gUG · Hamburg · NCT07319442

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.