Ulcerative Colitis (UC)IDEA-TNFNCT06896305
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
A study testing CDED (Crohn's Disease Exclusion Diet) in addition to anti-TNF therapy and Anti-TNF Therapy in people with Ulcerative Colitis (UC) and Crohn Disease (CD), run by IRCCS Ospedale San Raffaele at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis (UC), Crohn Disease (CD)
- What is being tested?
- CDED (Crohn's Disease Exclusion Diet) in addition to anti-TNF therapy and Anti-TNF Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- 22 May 2025to 1 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Ability and willingness to comply with the Crohn's DiseaseExclusion Diet (CDED)
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Ospedale San Raffaele
Milan, Michigan, 20132
Tommaso Lorenzo Parigi, MD, +39 02 2643 2756, parigi.tommaso@hsr.it
Annunziata Bruno, MS, +39 02 2643 2756, bruno.annunziata@hsr.it
About this study
Official title: Impact of Diet on the Effectiveness of Anti-TNF Therapy in Inflammatory Bowel Disease: a Prospective, Randomized, Double Arm, Open-label Study
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.
Read more
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.
Read the 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)
- Being tested
- CDED (Crohn's Disease Exclusion Diet) in addition to anti-TNF therapy, Anti-TNF Therapy
- Keywords
- Inflammatory Bowel Disease, Anti-TNF, Crohn's Disease Exclusion Diet, Ulcerative colitis, Crohn
- Medical subject headings
- Colitis, Ulcerative, Crohn Disease, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CDED (Crohn's Disease Exclusion Diet) in addition to anti-TNF therapyCombination 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
Anti-TNF TherapyDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Drug: Anti-TNF Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Week 14/16
Secondary outcomes (7)
Endoscopic response and endoscopic remission
- Rate of endoscopic response for CD (SES-CD score reduction of 25% or more and of 50% or more from baseline) and for UC (endoscopic Mayo score reduction of at least 1 or more points)
- Rate of endoscopic remission for CD (SES-CD score ≤3) and for UC (Mayo endoscopic score ≤1)
Measured: Week 24
Early and late efficacy and persistence of benefits
Rate of symptomatic remission (Harvey- Bradshaw Index < 5 and Partial Mayo Score <2) at week 6 and 24
Measured: Week 6/ Week 24
Biochemical response
- Change in C-reactive protein (CRP) levels from baseline
- Change in fecal calprotectin levels from baseline
Measured: Week 6, 14/16, 24
Sonographic improvement
- Change in BUSS (for CD) or MUC (for UC) from baseline
- Rate of patients in transmural response (bowel wall thickness ≤3mm and no increase in bowel wall flow)
Measured: Week 6, 14/16, 24
Tolerability and compliance to the Crohn's Disease Exclusion Diet (CDED)
Percentage of patients self-reporting adherence to CDED
Measured: Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
Quality of life assessed using the Short-IBD-Q questionnaire
Change in Short-IBDQ questionnare score. Quality of life will be assessed using the validated Italian translation of the Short-IBD-Q questionnaire
Measured: Week 14/16, week 24
Safety of the combination of biological therapy and CDED
Incidence and type of adverse events during the study period
Measured: From baseline until the end of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2025
- Study start22 May 2025
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative Colitis (UC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Ospedale San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tommaso Lorenzo Parigi, IRCCS Ospedale San Raffaele
- Investigators
- Tommaso Lorenzo Parigi, MD, Principal investigator, IRCCS Ospedale San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06896305
- Sponsor's protocol ID
- IDEA-TNF
- Acronym
- IDEA-TNF
- Status last verified
- Jan 2026
- First submitted
- 2 Feb 2025
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- Acronym / sponsor ID
- IDEA-TNF / IDEA-TNF
- Conditions
- Ulcerative Colitis (UC), Crohn Disease (CD)
- Keywords
- Inflammatory Bowel Disease, Anti-TNF, Crohn's Disease Exclusion Diet, Ulcerative colitis, Crohn
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- IRCCS Ospedale San RaffaeleUniversity, hospital or other
- Study start
- 22 May 2025 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 26 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Combination Product: CDED (Crohn's Disease Exclusion Diet) in addition to anti-TNF therapyPatients who accept participation and are randomized to receive dietary advice on the CDED diet will be included in the intervention group. |
| Control group | Active comparator | Drug: Anti-TNF TherapyThe control group will receive only anti-TNF therapy as per the standard of care and guidelines recommendation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
- Ability and willingness to comply with the Crohn's DiseaseExclusion Diet (CDED)
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CDED (Crohn's Disease Exclusion Diet) in addition to anti-TNF therapyPatients 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 | Combination product | Intervention group |
| Anti-TNF TherapyThe 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. | Drug | Control group |
Primary outcome
Efficacy of CDED in addition to anti-TNF therapy in active CD and UC versus anti-TNF therapy
Time frame: Week 14/16
Rate of symptomatic remission (Harvey - Bradshaw Index <5 for CD or Partial Mayo Score <2) for UC
7 secondary outcomes
Endoscopic response and endoscopic remission
Time frame: Week 24
Early and late efficacy and persistence of benefits
Time frame: Week 6/ Week 24
Biochemical response
Time frame: Week 6, 14/16, 24
Sonographic improvement
Time frame: Week 6, 14/16, 24
Tolerability and compliance to the Crohn's Disease Exclusion Diet (CDED)
Time frame: Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
Quality of life assessed using the Short-IBD-Q questionnaire
Time frame: Week 14/16, week 24
Safety of the combination of biological therapy and CDED
Time frame: From baseline until the end of the study
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tommaso Lorenzo Parigi, MD principal investigator
IRCCS Ospedale San Raffaele
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CDED (Crohn's Disease Exclusion Diet) in addition to anti-TNF therapy and Anti-TNF Therapy in people with Ulcerative Colitis (UC) and Crohn Disease (CD), run by IRCCS Ospedale San Raffaele at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tommaso Lorenzo Parigi, MD (+39 02 2643 2756, parigi.tommaso@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of CDED in addition to anti-TNF therapy in active CD and UC versus anti-TNF therapy (time frame: Week 14/16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.