NCT06896305 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
| NCT ID | NCT06896305 |
| Status | Recruiting |
| Phase | — |
| Sponsor | IRCCS Ospedale San Raffaele |
| Condition | Ulcerative Colitis (UC) |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2025-05-22 |
| Primary Completion | 2027-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2025-05-22 with a primary completion date of 2027-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Tommaso Lorenzo Parigi, MD
PRINCIPAL INVESTIGATOR
IRCCS Ospedale San Raffaele
Frequently Asked Questions
Who can join the NCT06896305 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Ulcerative Colitis (UC). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06896305 currently recruiting?
Yes, NCT06896305 is actively recruiting participants. Contact the research team at parigi.tommaso@hsr.it for enrollment information.
Where is the NCT06896305 trial being conducted?
This trial is being conducted at Milan, Italy.
Who is sponsoring the NCT06896305 clinical trial?
NCT06896305 is sponsored by IRCCS Ospedale San Raffaele. The principal investigator is Tommaso Lorenzo Parigi, MD at IRCCS Ospedale San Raffaele. The trial plans to enroll 80 participants.
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