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.
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
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