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

NCT ID: NCT06896305

Last Updated: 2026-01-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-22
• Study Completion Date: 2027-10-01

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.

Detailed Description

This is a prospective interventional, single-center, double-group, open-label study.

Primary objective is to compare the efficacy of CDED in addition to anti-TNF therapy in active CD and UC versus anti-TNF therapy alone.

Secondary objective are:

• Endoscopic response
• Endoscopic remission
• Early and late efficacy and persistence of benefits
• Biochemical response
• Sonographic improvement
• Tolerability and compliance to the Crohn's Disease ExclusionDiet (CDED)
• Quality of life-Safety of the combination of biological therapy and CDED. The subjects considered are adult patients diagnosed with moderate-to-severe Crohn's disease or moderate-to-severe ulcerative colitis who are starting therapy with an approved anti-TNF agent (infliximab and adalimumab for both UC and CD, and golimumab only for UC).

Conditions

Ulcerative Colitis (UC); Crohn Disease (CD)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention group

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

Group Type: EXPERIMENTAL

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

Intervention Type: 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

Control group

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

Group Type: ACTIVE_COMPARATOR

Anti-TNF Therapy

Intervention Type: 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.

Interventions

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

Intervention Type: COMBINATION_PRODUCT

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Participant is willing and able to give informed consent forparticipation in the study

2. Males or Females, Adults aged 18 years or older

3. Confirmed diagnosis of moderate-to-severe Crohn's disease orulcerative colitis

4. Patients who are planned to start anti-TNF therapy

5. Ability and willingness to comply with the Crohn's DiseaseExclusion Diet (CDED)

Exclusion Criteria

1. Patients with undetermined inflammatory bowel disease

2. Patients with metabolic or gastrointestinal conditions that couldinterfere or are incompatible with the study intervention (e.i.celiac disease, diabetes etc)

3. Patients with a body-mass index lower than 17 or greater than30

4. Patients who previously underwent intestinal resectionirrespective of cause

5. Patients currently on exclusive enteral nutrition (EEN)

6. Patients who have previously used or are currently adhering toCDED

7. Pregnant or breastfeeding women

8. Patients with a history of severe allergic reactions orintolerance to any food recommended in CDED

9. Patients with significant comorbidities that may interfere withthe study or pose a risk to the participant

10. Inability or unwillingness to comply with study protocols orfollow-up schedules

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS Ospedale San Raffaele

OTHER

Sponsor Role: lead

Responsible Party

Tommaso Lorenzo Parigi

Gastroenterologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tommaso Lorenzo Parigi, MD

Role: PRINCIPAL_INVESTIGATOR

IRCCS Ospedale San Raffaele

Locations

IRCCS Ospedale San Raffaele

Milan, Michigan, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Tommaso Lorenzo Parigi, MD

Role: CONTACT

parigi.tommaso@hsr.it

+39 02 2643 2756

Annunziata Bruno, MS

Role: CONTACT

bruno.annunziata@hsr.it

+39 02 2643 2756

Facility Contacts

Tommaso Lorenzo Parigi, MD

Role: primary

parigi.tommaso@hsr.it

+39 02 2643 2756

Annunziata Bruno, MS

Role: backup

bruno.annunziata@hsr.it

+39 02 2643 2756

Other Identifiers

IDEA-TNF

Identifier Type: -

Identifier Source: org_study_id