Assessment of Non-invasive Tools for Detecting Active Inflammatory Bowel Disease

• Conditions: Inflammatory Bowel Disease (IBD); Crohn Disease (CD); Ulcerative Colitis (UC)

• Registration Number: NCT06722456
• Lead Sponsor: Jean-François Beaulieu

Brief Summary

Part of the success of the treatment of people living with inflammatory bowel diseases (IBD) depends on the information that the doctor can obtain from the different clinical tests. Some of these tests are invasive such as the colonoscopy but other such the fecal calprotectin test, which measures intestinal inflammation, are non-invasive and useful to evaluate the success of the treatments. Unfortunately, the results from the non-invasive tests are not always clear and need to be complete with invasive tests for the right diagnosis.

The aim of this research is to test new stool markers for assisting the gastroenterologist to diagnose inflammatory bowel conditions including Crohn's disease (CD) and ulcerative colitis (UC) and to carefully monitoring the effects of medications on remission. We are using applications based on the use of mass spectrometry for identifying the proteins that are released by the host in the stools. We have identified more than 400 proteins in total. Based on informatics, we have been able to produce lists of unique stool proteins that can rapidly inform the doctor if the person has an IBD, whether it is a CD or an UC and, more importantly for the treatment, if the IBD is active or in remission.

The purpose of this study is to validate these protein markers in a blind test, where the real diagnosis will only be revealed after the analysis of the samples.

This study will bring a new power tool to assist the gastroenterologist in the treatment of people living with IBD.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-30
• Study First Submitted: 2024-11-28
• Status Verified: 2024-12
• Study First Submitted QC: 2024-12-03
• Last Update Submitted: 2024-12-03
• Study First Posted: 2024-12-09
• Last Update Posted: 2024-12-09
• Primary Completion: 2025-06-30
• Study Completion: 2025-12-15

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Be affected with one of the two main inflammatory bowel diseases (Crohn's disease of ulcerative colitis).
• Be invited to participate on the base of a routine follow up by their gastroenterologist.
• Be scheduled for a calprotectin test and a colonoscopy.
• Accept to participate and provide an extra stool sample for analysis.

Exclusion Criteria

• Having no history of inflammatory bowel disease.
• Be affected with an history of gastrointestinal disease other than Crohn disease or ulcerative colitis.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Scoring intestinal inflammation from stool protein analyses	From enrolment to the end of full data compilation, assessed up to 15 months	Assessing activity in patients affected with Crohn's disease or ulcerative colitis on a 0 to 1.0 score (0 as best score for remission to 1.0 as maximal score for activity) for evaluating intestinal inflammation by proteomics analysis of stools relative to standard clinical criteria (symptoms and results from colonoscopy, histopathology and fecal calprotectin).

Secondary Outcome Measures

Name	Time	Method
To compare activity scores deduced from proteomics analyses to the results from colonoscopy and pathology.	From enrolment to the end of full data compilation, assessed up to 15 months	Assessing activity in patients affected with Crohn's disease or ulcerative colitis on a 0 to 1.0 score for evaluating intestinal inflammation by proteomics analysis of stools relative to the results from colonoscopy and histopathology.
To compare activity scores deduced from proteomics analyses to the results from pathology.	From enrolment to the end of full data compilation, assessed up to 15 months	Assessing activity in patients affected with Crohn's disease or ulcerative colitis on a 0 to 1.0 score for evaluating intestinal inflammation by proteomics analysis of stools relative to the results from histopathology.
To compare activity scores deduced from proteomics analyses to the results from fecal calprotectin.	From enrolment to the end of full data compilation, assessed up to 15 months	Assessing activity in patients affected with Crohn's disease or ulcerative colitis on a 0 to 1.0 score for evaluating intestinal inflammation by proteomics analysis of stools relative to the results of fecal calprotectin.

Trial Locations

Locations (1)

Centre de recherche of the CIUSSS de l'Estrie-CHUS; 🇨🇦 Sherbrooke, Quebec, Canada