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

NANot yet recruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

April 1, 2025

Primary Completion Date

April 1, 2027

Study Completion Date

October 1, 2027

Conditions
Ulcerative Colitis (UC)Crohn Disease (CD)
Interventions
COMBINATION_PRODUCT

CDED (Crohn's Disease Exclusion Diet) in addition to anti-TNF therapy

"Patients 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"

DRUG

Anti-TNF Therapy

The 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.

Trial Locations (1)

20132

IRCCS Ospedale San Raffaele, Milan

All Listed Sponsors
lead

IRCCS Ospedale San Raffaele

OTHER

NCT06896305 - Impact of Exclusion Diet in Addition to Anti-TNF Therapy in Crohn's Disease and Ulcerative Colitis: a Prospective, Double Arm, Open-label Study | Biotech Hunter | Biotech Hunter