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
Recruiting
N/A
Interventional Study
Ulcerative Colitis (UC)
Crohn Disease (CD)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 80 (estimated)
- Sponsor
- IRCCS Ospedale San Raffaele · Other
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About This Trial
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 st…
Trial Locations
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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.…
Contacts