Adding the Crohn's Disease Exclusion Diet to anti-TNF treatment for Crohn's disease and ulcerative colitis
Impact of Diet on the Effectiveness of Anti-TNF Therapy in Inflammatory Bowel Disease: a Prospective, Randomized, Double Arm, Open-label Study
This will test whether adding the Crohn's Disease Exclusion Diet to anti‑TNF medicines helps adults with active Crohn's disease or ulcerative colitis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IRCCS Ospedale San Raffaele Academic / other |
| Drugs / interventions | infliximab, adalimumab, golimumab |
| Locations | 1 site (Milan, Michigan) |
| Trial ID | NCT06896305 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults (18+) with confirmed moderate-to-severe Crohn's disease or ulcerative colitis who are about to start an approved anti‑TNF agent and are willing and able to follow the CDED diet.
Not a fit: Patients unlikely to benefit include those with incompatible metabolic or gastrointestinal conditions (e.g., celiac disease, diabetes), BMI outside 17–30, prior intestinal resection, current exclusive enteral nutrition, prior CDED use, or pregnant or breastfeeding individuals.
Why it matters
Potential benefit: If successful, adding CDED to anti‑TNF therapy could raise response and remission rates and improve patients' quality of life while potentially reducing the need for additional treatments.
How similar studies have performed: CDED has shown benefit especially in pediatric Crohn's disease and as an alternative to exclusive enteral nutrition, but evidence for adding CDED to biologic therapy in adults is limited and not well established.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Milan, Michigan
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.