Genetic Determinism of Epithelial Barrier Defects in Irritable Bowel Syndrome

NCT02841878 | Withdrawn

• 1 other identifier: 14-PP-20
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Irritable bowel syndrome (IBS) profoundly affects the quality of life. Mucosal micro-inflammation, epithelial permeability disorder and proteases activity increase have been demonstrated in the patients' gastrointestinal tract. Protease activity increase could be subjected to a genetic determinism (decrease in proteases inhibitors genes expression). Objectives: 1/ To study relations between proteases activity (in stool and colonic biopsies supernatants), proteases inhibitors genes expression and mucosal cellular infiltrate (IBS patients and healthy subjects). 2/ Establishing a correlation between proteases activity, mucosal micro-inflammation and symptoms. 3/ To evaluate proteases inhibitors therapeutic potential. Expected results: 1/ Decreased expression of proteases inhibitors genes in subjects with IBS. 2/ Correlation of symptoms with proteases activity intensity. 3/ Demonstration of restorative potential of proteases inhibitors.

Conditions

Irritable Bowel Syndrome (IBS)

Outcome Measures

Primary Outcomes (3)

• Clinical criteria

  Abdominal Pain : Francis scoring

  at the medical visit

• Clinical criteria

  Transit disorders : Rome III criteria questionnaire

  at day one

• Clinical criteria

  Quality of life alteration (questionnaires)

  at day one

Secondary Outcomes (3)

• Experimental criteria

  at day one

• Experimental criteria

  at day one

• Experimental criteria

  at day one

Study Arms (1)

analysis on colorectal biopsy

OTHER

* Proteases activity (cystein and serin proteases) * Proteases inhibitors genes expression (Serpins A1 / E1) * Colonic biopsies permeabilityTight junctions genes expression * Cytokines genes expression (TNFalpha, interleukines) * Cellularity on histologic sections

Genetic: Analysis on colorectal biopsy

Interventions

Analysis on colorectal biopsy GENETIC

analysis on colorectal biopsy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient with irritable bowel syndrome (IBS), defined by Rome III criteria (patient group)
• Patients coming for screening colonoscopy (control group)

You may not qualify if:

• Active inflammatory bowel disease
• Infectious bowel disease or other cause that could explain digestive symptoms
• Patients coming for screening colonoscopy without inflammatory bowel disease or IBS

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

Department of gastroenterology, Hopital Archet 2

Nice, 06002, France

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Thierry PICHE, MD

  Nice University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2015
• First Posted: July 22, 2016
• Study Start: September 1, 2016
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: February 22, 2018

Record last verified: 2018-02

Locations

FR (1)