Bologna IBD Markers

Study Overview
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Brief Summary
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Individuate possible predictive factors of anti-TNFalfa-induced deep remission in Crohn's disease.

Detailed Description
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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.

Official Title
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Predictive Factors of Anti-TNFalfa-induced Deep Remission in Crohn's Disease

Conditions
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Crohn's Disease

Participation Criteria
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Eligibility Criteria
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Main Inclusion Criteria for IBD patients: Adult patients (Caucasian) Moderate-severe active Crohns disease (220≤ CDAI ≤450; blood CRP ≥5 mg/L and/or fecal calprotectin ≥250mg/L) Indication for anti-TNF therapy according to the normal clinical practice Informed consent signed Main Exclusion Criteria for IBD patients: Changes of Crohns disease treatment gastrointestinal medication (including corticosteroids) within the previous 2 weeks prior to enrollment Pregnant or breast-feeding (at index date) female patients Main Inclusion Criteria for no-IBD controls: No-IBD adult controls (Caucasian) with no GI disorders, as defined by medical history and standard clinical chemistry values, afferent to the out-patient clinic Informed consent signed Main Exclusion criteria for no-IBD controls: Medical history of digestive diseases Digestive, renal or metabolic disease, as determined by the medical visit and sa blood chemistry analysis

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| IBD patients<br>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<br>30 no-IBD controls with no GI disorders, as defined by medical history and standard clinical chemistry values, afferent to the out-patient clinic | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of IBD patients in clinical remission at 12 months | Subjects without intestinal ulceration at endoscopy at 12 months Subjects with CDAI score below 150 from baseline to 12 months Subjects with blood CRP value below 0.8 mg/dL from baseline to 12 months Subjects with stool calprotectin value below 50ug/g from baseline to 12 months Through analysis of metabonomics on biopsies, blood, urine and stools Through analysis of blood genotyping Through analysis of gut microbiota composition | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of IBD patients requiring an escalation treatment to be in clinical remission at 12 months | Subjects without intestinal ulceration at endoscopy at 12 months Subjects with CDAI score below 150 from baseline to 12 months Subjects with blood CRP value below 0.8 mg/dL from baseline to 12 months Subjects with stool calprotectin value below 50ug/g from baseline to 12 months Through analysis of metabonomics on biopsies, blood, urine and stools Through analysis of blood genotyping Through analysis of gut microbiota composition | Baseline vs Baseline + 12 months | 
| Assess phenotypic traits between IBD patients in clinical remission at 12 months and non-IBD subjects | Through analysis of metabonomics on blood, urine and stools Through analysis of gut microbiota composition Through clinical nutritional status in IBD patients compared to 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 | Through analysis of gut microbiota composition Through clinical nutritional status | Baseline |