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The JIA-ED study is a pilot project. Based on experience in another inflammatory disease, a 4-week period was extrapolated as sufficient to assess the effectiveness of the experimental intervention. This observation is supported by literature data showing that, halfway through phase I of the CDED (Crohn Diseasse Exclusion Diet), it is already possible to identify a subset of patients with Crohn's disease who are responsive to the dietary treatment and who also have a higher likelihood of achieving clinical remission by the end of the first phase of the diet itself.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of care | No Intervention | In this arm patients of newly diagnosis, or who failed synthetic or biologic therapy will be treated with standard of care therapy and free diet | |
| Intervention arm | Experimental | In this arm patients of newly diagnosis, or who failed synthetic or biologic therapy will be treated with the Crohn Disease Exclusion Diet (CDED) plus partial enteral nutrition |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| complete, polymeric formula, fiber, lactose and gluten free | Dietary Supplement | The dietary intervention attempts to induce remission in the first 4-week treatment without any change in the pharmaceutical therapy. In case of worsening or not reaching the outcomes, the patient will be defined as a failure and start rescue therapy with the standard of care. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients showing 20% improvement in juvenile arthritic disease activity score (JADAS) | Baseline, 4 weeks, 8 weeks post-enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients showing a high score on the Modulence Adherence Rating Scale (MARS) | Week 4, week 8, week 16, week 26 post-enrollment | |
| Number of patients showing reduction of Reactive C Protein (RCP) after exclusion diet | Baseline, 4 weeks, 8 weeks post-enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with gut microbiota modifications | Baseline, week 4, week 8, week 16, week 26 post-enrollment |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Polo Lionetti, MD, PhD, Ordinary Professor | Contact | +39 3398416059 | paolo.lionetti@unifi.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AOU Meyer IRCCS | Recruiting | Florence | 50139 | Italy |
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| ID | Term |
|---|---|
| D001171 | Arthritis, Juvenile |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D004043 | Dietary Fiber |
| D007785 | Lactose |
| D055050 | Diet, Gluten-Free |
| ID | Term |
|---|---|
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
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|
| Number of patients showing reduction of erythrocyte sedimentation rate (ESR) after exclusion diet | Baseline, 4 weeks, 8 weeks post-enrollment |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D010829 |
| Physiological Phenomena |
| D019602 | Food and Beverages |
| D004187 | Disaccharides |
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |
| D000073893 | Sugars |
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 | Nutritional Physiological Phenomena |