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 (IDEA-TNF)

IRCCS Ospedale San Raffaele

Status: Enrolling

Conditions: Ulcerative Colitis (UC); Crohn Disease (CD)

Treatments: Combination Product: CDED (Crohn's Disease Exclusion Diet) in addition to anti-TNF therapy; Drug: Anti-TNF Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06896305

IDEA-TNF

Details and patient eligibility

About

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.

Full 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).

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Intervention group

Experimental group

Description:

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

Treatment:

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

Control group

Active Comparator group

Description:

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

Treatment:

Drug: Anti-TNF Therapy