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
Not applicable · Testing CDED (Crohn's Disease Exclusion Diet) in addition to anti-TNF therapy and Anti-TNF Therapy · 1 site · IRCCS Ospedale San Raffaele
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing CDED (Crohn's Disease Exclusion Diet) in addition to anti-TNF therapy (a combination product) and Anti-TNF Therapy (a drug) as a possible treatment. Condition(s) listed: Ulcerative Colitis (UC) and Crohn Disease (CD).
Participants are assigned to groups by chance (randomized).
It is open-label: participants know what they are receiving.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- 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
Plus 2 more requirement(s). There are also 10 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 80 participants are expected to take part.
- Start date: 2025-05-22.
- Main results expected around 2027-04-01 (estimate from the record).
- 1 study site listed (1 marked recruiting) in Italy.
Main thing being measured
- Efficacy of CDED in addition to anti-TNF therapy in active CD and UC versus anti-TNF therapy (Week 14/16)
In the researchers’ words
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…
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Ulcerative Colitis (UC); Crohn Disease (CD) |
| Lead sponsor | IRCCS Ospedale San Raffaele |
| Enrollment | 80 (estimated) |
| Start date | 2025-05-22 |
| Primary completion (est.) | 2027-04-01 |
| First posted | 2025-03-26 |
| Last updated | 2026-01-22 |
| Official title | Impact of Diet on the Effectiveness of Anti-TNF Therapy in Inflammatory Bowel Disease: a Prospective, Randomized, Double Arm, Open-label Study |
| ClinicalTrials.gov ID | NCT06896305 |
Interventions
- 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 p… - 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.
Full eligibility criteria (from the record)
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
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| IRCCS Ospedale San Raffaele | Milan, Michigan | Italy | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.