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
Parallel
CDED (Crohn's Disease Exclusion Diet) in addition to anti-TNF therapy
Combination productPatients in the experimental group will receive professional dietary advice on how to adhere to CDED for 12 weeks, in addition to anti-TNF therapy while patients in the control group will receive only anti-TNF therapy for the entire duration of the study. Diet adherence is completely voluntary and is not enforced in any way. CDED is divided into 3 phases, the first two, grouped as the induction phase, with 6 weeks of strict diet and 6 weeks to gradual food reintroduction, followed by 12 weeks of patients follow-up. Five foods (chicken, eggs, potatoes, apple and bananas) are permitted at the start of the diet; the patient can then choose to consume a range of permitted foods at will, the variability of which increases after the first six weeks
Anti-TNF Therapy
DrugThe control group will receive only anti-TNF therapy as per standard of care. This therapy is recommended by guidelines and is the cornerstone of treatment of Crohn's disease and ulcerative colitis.
Efficacy of CDED in addition to anti-TNF therapy in active CD and UC versus anti-TNF therapy
Rate of symptomatic remission (Harvey - Bradshaw Index \<5 for CD or Partial Mayo Score \<2) for UC
Endoscopic response and endoscopic remission
* Rate of endoscopic response for CD (SES-CD score reduction of 25% or more and of 50% or more from baseline) and for UC (endoscopic Mayo score reduction of at least 1 or more points) * Rate of endoscopic remission for CD (SES-CD score ≤3) and for UC (Mayo endoscopic score ≤1)
Early and late efficacy and persistence of benefits
Rate of symptomatic remission (Harvey- Bradshaw Index \< 5 and Partial Mayo Score \<2) at week 6 and 24
Biochemical response
* Change in C-reactive protein (CRP) levels from baseline * Change in fecal calprotectin levels from baseline
Sonographic improvement
* Change in BUSS (for CD) or MUC (for UC) from baseline * Rate of patients in transmural response (bowel wall thickness ≤3mm and no increase in bowel wall flow)
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