Impact of Exclusion Diet in Addition to Anti-TNF Therapy in Crohn's Disease and Ulcerative Colitis: a Prospective, Double Arm, Open-label Study

Launched by IRCCS OSPEDALE SAN RAFFAELE · Mar 19, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how a special diet, called the Crohn's Disease Exclusion Diet (CDED), can help improve treatment outcomes for adults with active Crohn's disease or ulcerative colitis when combined with standard medication known as anti-TNF therapy. The researchers want to find out if following this specific diet along with the medication can help patients feel better and improve their quality of life.

To participate in this study, you need to be an adult aged 18 or older who has been diagnosed with moderate-to-severe Crohn's disease or ulcerative colitis and is about to start anti-TNF therapy. If you join, you'll be placed in one of two groups: one group will receive only the standard therapy, while the other will also get guidance on following the CDED. The study is not recruiting yet, but if you're interested in learning more about it or think you might qualify, it's a good idea to talk to your doctor.

Gender

ALL

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