Actively Recruiting
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
Led by IRCCS Ospedale San Raffaele · Updated on 2026-01-22
80
Participants Needed
1
Research Sites
123 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to give informed consent for participation in the study
- Male or female adults aged 18 years or older
- Confirmed diagnosis of moderate-to-severe Crohn's disease or ulcerative colitis
- Planned to start anti-TNF therapy
- Able and willing to comply with the Crohn's Disease Exclusion Diet (CDED)
You will not qualify if you...
- Diagnosis of undetermined inflammatory bowel disease
- Metabolic or gastrointestinal conditions interfering with the study (e.g., celiac disease, diabetes)
- Body mass index lower than 17 or greater than 30
- Previous intestinal resection surgery
- Currently on exclusive enteral nutrition (EEN)
- Previous or current adherence to Crohn's Disease Exclusion Diet (CDED)
- Pregnant or breastfeeding women
- History of severe allergic reactions or intolerance to foods recommended in CDED
- Significant other health conditions that may interfere with the study or risk participant safety
- Unable or unwilling to comply with study protocols or follow-up schedules
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
IRCCS Ospedale San Raffaele
Milan, Michigan, Italy, 20132
Actively Recruiting
Research Team
T
Tommaso Lorenzo Parigi, MD
CONTACT
A
Annunziata Bruno, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here