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 · NCT06896305 · Interventional (participants receive a specific treatment) · Lead sponsor: IRCCS Ospedale San Raffaele
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
Inclusion criteria
- 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 criteria
- 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
Where it is running
2 locations listed.
- IRCCS Ospedale San Raffaele - Milan, Michigan, Italy
- IRCCS Ospedale San Raffaele - Milan, Michigan, Italy