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

Set-up of Mass Spectrometry-based Stool Tests for Improving the Diagnosis and Management of Inflammatory Bowel Disease

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Inflammatory Bowel Disease (IBD); Crohn Disease (CD); Ulcerative Colitis (UC)
• Intervention / Treatment: Diagnostic test: Analysis of protein signatures in stool samples

• Study Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Sherbrooke, Quebec, Canada, J1H 5N4
      • Centre de recherche of the CIUSSS de l'Estrie-CHUS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients followed by a gastroenterologist at the CIUSS de l'Estrie-CHUS.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
IBD in remission; Patient affected with an inflammatory bowel disease that is considered in remission.	Diagnostic test: Analysis of protein signatures in stool samples; Stool protein signatures are to be established in parallel to standard clinical evaluation of the intestinal inflammatory activity.
IBD active; Patient affected with an inflammatory bowel disease that is considered under an active state.	Diagnostic test: Analysis of protein signatures in stool samples; Stool protein signatures are to be established in parallel to standard clinical evaluation of the intestinal inflammatory activity.
IBD not classified; Patient affected with an inflammatory bowel disease that is difficult to classify as active or in remission.	Diagnostic test: Analysis of protein signatures in stool samples; Stool protein signatures are to be established in parallel to standard clinical evaluation of the intestinal inflammatory activity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Scoring intestinal inflammation from stool protein analyses	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).	From enrolment to the end of full data compilation, assessed up to 15 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To compare activity scores deduced from proteomics analyses to the results from colonoscopy and pathology.	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.	From enrolment to the end of full data compilation, assessed up to 15 months
To compare activity scores deduced from proteomics analyses to the results from pathology.	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.	From enrolment to the end of full data compilation, assessed up to 15 months
To compare activity scores deduced from proteomics analyses to the results from fecal calprotectin.	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.	From enrolment to the end of full data compilation, assessed up to 15 months

Collaborators and Investigators

• Sponsor: Jean-François Beaulieu

Publications and helpful links

General Publications

• Shajari E, Gagne D, Malick M, Roy P, Noel JF, Gagnon H, Brunet MA, Delisle M, Boisvert FM, Beaulieu JF. Application of SWATH Mass Spectrometry and Machine Learning in the Diagnosis of Inflammatory Bowel Disease Based on the Stool Proteome. Biomedicines. 2024 Feb 1;12(2):333. doi: 10.3390/biomedicines12020333.

Helpful Links

• Laboratory webpage on research pertaining to inflammatory bowel disease.

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2024
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): December 15, 2025

Study Registration Dates

• First Submitted: November 28, 2024
• First Submitted That Met QC Criteria: December 3, 2024
• First Posted (Estimated): December 9, 2024

Study Record Updates

• Last Update Posted (Estimated): December 9, 2024
• Last Update Submitted That Met QC Criteria: December 3, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Diagnosis; Remission; Non-invasive
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Crohn Disease; Intestinal Diseases; Inflammatory Bowel Diseases
• Other Study ID Numbers: 90-18A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD that underlies results in a publication will be shared.
• IPD Sharing Time Frame: Starting 6 months after publication
• IPD Sharing Access Criteria: Study protocol and SAP will be accessible from the publication.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No