Clinical trial 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
Official title: Impact of Diet on the Effectiveness of Anti-TNF Therapy in Inflammatory Bowel Disease: a Prospective, Double Arm, Open-label Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Ulcerative Colitis (UC)
Crohn Disease (CD)
Keywords: Inflammatory Bowel Disease
Anti-TNF
Crohn's Disease Exclusion Diet
Ulcerative colitis
Crohn
Lead sponsor: IRCCS Ospedale San Raffaele
Sponsor class: OTHER
First posted: 2025-03-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will divided 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. In addition, becuase diet adherence requires personal commitment randomization will not be performed.
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Efficacy of CDED in addition to anti-TNF therapy in active CD and UC versus anti-TNF therapy
timeFrame: Week 14/16
Secondary outcomes:
measure: Endoscopic response and endoscopic remission
timeFrame: Week 24
measure: Early and late efficacy and persistence of benefits
timeFrame: Week 6/ Week 24
measure: Biochemical response
timeFrame: Week 6, 14/16, 24
measure: Sonographic improvement
timeFrame: Week 6, 14/16, 24
measure: Tolerability and compliance to the Crohn's Disease Exclusion Diet (CDED)
timeFrame: Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
measure: Quality of life assessed using the Short-IBD-Q questionnaire
timeFrame: Week 14/16, week 24
measure: Safety of the combination of biological therapy and CDED
timeFrame: From baseline until the end of the study
Other outcomes:
Locations:
city: Milano
country: Italy
facility: IRCCS Ospedale San Raffaele
state: Michigan
Study officials:
affiliation: IRCCS Ospedale San Raffaele
name: Tommaso Lorenzo Parigi, MD
role: PRINCIPAL_INVESTIGATOR
References: