Clinical trial NCT06722456: Assessment of Non-invasive Tools for Detecting Active Inflammatory Bowel Disease
Official title: Set-up of Mass Spectrometry-based Stool Tests for Improving the Diagnosis and Management of Inflammatory Bowel Disease
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Inflammatory Bowel Disease (IBD)
Crohn Disease (CD)
Ulcerative Colitis (UC)
Keywords: Diagnosis
Non-invasive
Remission
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
First posted: 2024-12-09
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients followed by a gastroenterologist at the CIUSS de l'Estrie-CHUS.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Scoring intestinal inflammation from stool protein analyses
timeFrame: From enrolment to the end of full data compilation, assessed up to 15 months
Secondary outcomes:
measure: To compare activity scores deduced from proteomics analyses to the results from colonoscopy and pathology.
timeFrame: From enrolment to the end of full data compilation, assessed up to 15 months
measure: To compare activity scores deduced from proteomics analyses to the results from pathology.
timeFrame: From enrolment to the end of full data compilation, assessed up to 15 months
measure: To compare activity scores deduced from proteomics analyses to the results from fecal calprotectin.
timeFrame: From enrolment to the end of full data compilation, assessed up to 15 months
Other outcomes:
Locations:
city: Sherbrooke
country: Canada
facility: Centre de recherche of the CIUSSS de l'Estrie-CHUS
state: Quebec
Study officials:
References:
citation: 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.