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

NCT06896305 | Recruiting DMC

• 1 other identifier: IDEA-TNF
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Crohn Disease (CD); Ulcerative Colitis (UC)

Keywords

Inflammatory Bowel Disease; Anti-TNF; Crohn's Disease Exclusion Diet; Ulcerative colitis; Crohn

Outcome Measures

Primary Outcomes (1)

• 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

  Week 14/16

Secondary Outcomes (7)

• Endoscopic response and endoscopic remission

  Week 24

• Early and late efficacy and persistence of benefits

  Week 6/ Week 24

• Biochemical response

  Week 6, 14/16, 24

• Sonographic improvement

  Week 6, 14/16, 24

• Tolerability and compliance to the Crohn's Disease Exclusion Diet (CDED)

  Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12

Study Arms (2)

Intervention group

EXPERIMENTAL

Patients who accept participation and are randomized to receive dietary advice on the CDED diet will be included in the intervention group.

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

Control group

ACTIVE COMPARATOR

The control group will receive only anti-TNF therapy as per the standard of care and guidelines recommendation

Drug: Anti-TNF Therapy

Interventions

Anti-TNF Therapy DRUG

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.

Control group

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

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

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS Ospedale San Raffaele: lead

Study Sites (1)

IRCCS Ospedale San Raffaele

Milan, Michigan, 20132, Italy

RECRUITING

MeSH Terms

Conditions

Colitis, Ulcerative; Crohn Disease; Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Tommaso Lorenzo Parigi, MD

  IRCCS Ospedale San Raffaele

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tommaso Lorenzo Parigi, MD

CONTACT

+39 02 2643 2756; parigi.tommaso@hsr.it

Annunziata Bruno, MS

CONTACT

+39 02 2643 2756; bruno.annunziata@hsr.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Gastroenterologist

Model Details: Patients will be randomized into two groups: those receiving anti-TNF treatment and dietary advice, and those receiving anti-TNF treatment only. The nature of the procedure (dietary advice) prevents the investigator and participant from being blinded.

Study Record Dates

• First Submitted: February 2, 2025
• First Posted: March 26, 2025
• Study Start: May 22, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)