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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Control group | Active Comparator | The control group will receive only anti-TNF therapy as per the standard of care and guidelines recommendation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Week 14/16 |
| Measure | Description | Time Frame |
|---|---|---|
| Endoscopic response and endoscopic remission |
| Week 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tommaso Lorenzo Parigi, MD | Contact | +39 02 2643 2756 | parigi.tommaso@hsr.it | |
| Annunziata Bruno, MS | Contact | +39 02 2643 2756 | bruno.annunziata@hsr.it |
| Name | Affiliation | Role |
|---|---|---|
| Tommaso Lorenzo Parigi, MD | IRCCS Ospedale San Raffaele | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Ospedale San Raffaele | Recruiting | Milan | Michigan | 20132 | Italy |
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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.
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| 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. |
|
| 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 |
| Week 6/ Week 24 |
| Biochemical response |
| Week 6, 14/16, 24 |
| Sonographic improvement |
| Week 6, 14/16, 24 |
| Tolerability and compliance to the Crohn's Disease Exclusion Diet (CDED) | Percentage of patients self-reporting adherence to CDED | 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 | Week 14/16, week 24 |
| Safety of the combination of biological therapy and CDED | Incidence and type of adverse events during the study period | From baseline until the end of the study |
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| D003424 | Crohn Disease |
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
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