Assessment of Non-invasive Tools for Detecting Active Inflammatory Bowel Disease
NCT ID: NCT06722456
Last Updated: 2024-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
120 participants
OBSERVATIONAL
2024-05-30
2025-12-15
Brief Summary
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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
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Conditions
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Keywords
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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IBD in remission
Patient affected with an inflammatory bowel disease that is considered in remission.
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.
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Be affected with an history of gastrointestinal disease other than Crohn disease or ulcerative colitis.
18 Years
ALL
No
Sponsors
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Jean-François Beaulieu
OTHER
Responsible Party
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Jean-François Beaulieu
Professor
Locations
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Centre de recherche of the CIUSSS de l'Estrie-CHUS
Sherbrooke, Quebec, Canada
Countries
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References
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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.
Related Links
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Laboratory webpage on research pertaining to inflammatory bowel disease.
Other Identifiers
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90-18A
Identifier Type: -
Identifier Source: org_study_id