Bologna IBD Markers

Société des Produits Nestlé (SPN)84 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Crohn's Disease

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Bologna University

Bologna, Italy

Outcomes

Primary Outcomes

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

Time frame: 12 months

Secondary Outcomes

Number of IBD patients requiring an escalation treatment to be in clinical remission at 12 months

Time frame: 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

Time frame: 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

Time frame: Baseline

Data from ClinicalTrials.gov

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