Bologna IBD Markers

Completed

• Conditions: Crohn's Disease

• Registration Number: NCT02580864
• Lead Sponsor: Société des Produits Nestlé (SPN)

Brief Summary

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

Detailed Description

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 Timeline

• Study First Submitted: 2015-09-16
• Study Start: 2015-10
• Study First Submitted QC: 2015-10-19
• Study First Posted: 2015-10-20
• Primary Completion: 2018-10
• Study Completion: 2019-01
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-22
• Last Update Posted: 2019-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of IBD patients in clinical remission at 12 months	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

Secondary Outcome Measures

Name	Time	Method
Number of IBD patients requiring an escalation treatment to be in clinical remission at 12 months	Baseline vs Baseline + 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
Assess healthy intra-individual variability of gut microbial activity and dietary behavior in relation to disease development and management	Baseline	* Through analysis of gut microbiota composition; * Through clinical nutritional status
Assess phenotypic traits between IBD patients in clinical remission at 12 months and non-IBD subjects	Baseline vs Baseline + 12 months	* 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

Trial Locations

Locations (1)

Bologna University; 🇮🇹 Bologna, Italy