Bologna IBD Markers

Crohn's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02580864
• Other study ID #: 13.27.NIHS
• Status: Completed
• Start date: October 2015
• Est. completion date: January 2019

Study information

• Verified date: July 2019
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: January 2019
• Est. primary completion date: October 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Locations

Country	Name	City	State
Italy	Bologna University	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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