Status:
NOT_YET_RECRUITING
Impact of Exclusion Diet in Addition to Anti-TNF Therapy in Crohn's Disease and Ulcerative Colitis: a Prospective, Double Arm, Open-label Study
Lead Sponsor:
IRCCS Ospedale San Raffaele
Conditions:
Ulcerative Colitis (UC)
Crohn Disease (CD)
Eligibility:
All Genders
18+ years
Phase:
NA
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 i...
Detailed Description
This is a prospective interventional, single-center, double-group, open-label study. Primary objective is to compare the efficacy of CDED in addition to anti-TNF therapy in active CD and UC versus an...
Eligibility Criteria
Inclusion
- Participant is willing and able to give informed consent forparticipation in the study
- Males or Females, Adults aged 18 years or older
- Confirmed diagnosis of moderate-to-severe Crohn's disease orulcerative colitis
- Patients who are planned to start anti-TNF therapy
- Ability and willingness to comply with the Crohn's DiseaseExclusion Diet (CDED)
Exclusion
- Patients with undetermined inflammatory bowel disease
- Patients with metabolic or gastrointestinal conditions that couldinterfere or are incompatible with the study intervention (e.i.celiac disease, diabetes etc)
- Patients with a body-mass index lower than 17 or greater than30
- Patients who previously underwent intestinal resectionirrespective of cause
- Patients currently on exclusive enteral nutrition (EEN)
- Patients who have previously used or are currently adhering toCDED
- Pregnant or breastfeeding women
- Patients with a history of severe allergic reactions orintolerance to any food recommended in CDED
- Patients with significant comorbidities that may interfere withthe study or pose a risk to the participant
- Inability or unwillingness to comply with study protocols orfollow-up schedules
Key Trial Info
Start Date :
April 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2027
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06896305
Start Date
April 1 2025
End Date
October 1 2027
Last Update
March 26 2025
Active Locations (1)
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1
IRCCS Ospedale San Raffaele
Milan, Michigan, Italy, 20132