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Individuate possible predictive factors of anti-TNFalfa-induced deep remission in Crohn's disease.
This trial will be exploratory, open in vitro study on human tissues. 120 patients will be enrolled (Caucasian, male/female,18-65 years old) with moderate-severe active Crohns disease and with indication for anti-TNF therapy according to the normal clinical practice.
Simultaneously, 30 no-IBD controls with no GI disorders, as defined by medical history and standard clinical chemistry values, afferent to the out-patient clinic will be enrolled.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IBD patients | 120 adult patients (Caucasian, male/female,18-65 years old) with moderate-severe active Crohns disease (220≤ CDAI ≤450; blood CRP ≥5 mg/L and/or fecal calprotectin ≥250mg/L) and with indication for anti-TNF therapy according to the normal clinical practice | ||
| No-IBD patients | 30 no-IBD controls with no GI disorders, as defined by medical history and standard clinical chemistry values, afferent to the out-patient clinic |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of IBD patients in clinical remission at 12 months |
| 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of IBD patients requiring an escalation treatment to be in clinical remission at 12 months |
|
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Main Inclusion Criteria for IBD patients:
Main Exclusion Criteria for IBD patients:
Main Inclusion Criteria for no-IBD controls:
Main Exclusion criteria for no-IBD controls:
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120 adult patients with moderate-severe active Crohns disease with indication for anti-TNF therapy according to the normal clinical practice
30 no-IBD controls with no GI disorders, as defined by medical history and standard clinical chemistry values, afferent to the out-patient clinic
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bologna University | Bologna | 40138 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36675009 | Derived | Rizzello F, Gionchetti P, Spisni E, Saracino IM, Bellocchio I, Spigarelli R, Collini N, Imbesi V, Dervieux T, Alvisi P, Valerii MC. Dietary Habits and Nutrient Deficiencies in a Cohort of European Crohn's Disease Adult Patients. Int J Mol Sci. 2023 Jan 12;24(2):1494. doi: 10.3390/ijms24021494. |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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Blood, stool, biopsy and urine
| Baseline vs Baseline + 12 months |
| Assess phenotypic traits between IBD patients in clinical remission at 12 months and non-IBD subjects |
| Baseline vs Baseline + 12 months |
| Assess healthy intra-individual variability of gut microbial activity and dietary behavior in relation to disease development and management |
| Baseline |
| D007410 | Intestinal Diseases |