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

NCT06722456 | Enrolling By Invitation

• 1 other identifier: 90-18A
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Diagnosis; Non-invasive; Remission

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

• 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

• 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

Study Arms (3)

IBD in remission

Patient affected with an inflammatory bowel disease that is considered in remission.

Diagnostic Test: Analysis of protein signatures in stool samples

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

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

Interventions

Analysis of protein signatures in stool samples DIAGNOSTIC_TEST

Stool protein signatures are to be established in parallel to standard clinical evaluation of the intestinal inflammatory activity.

IBD active; IBD in remission; IBD not classified

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Jean-François Beaulieu: lead

Study Sites (1)

Centre de recherche of the CIUSSS de l'Estrie-CHUS

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Related Publications (1)

• 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.

  PMID: 38397935 BACKGROUND

Related Links

• Laboratory webpage on research pertaining to inflammatory bowel disease.

Biospecimen

Retention: SAMPLES WITHOUT DNA

Stool

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative; Disease

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 28, 2024
• First Posted: December 9, 2024
• Study Start: May 30, 2024
• Primary Completion: June 30, 2025
• Study Completion: December 15, 2025
• Last Updated: December 9, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Starting 6 months after publication
• Access Criteria: Study protocol and SAP will be accessible from the publication.

Locations

CA (1)