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Enrolling by Invitation

NCT Number: NCT06722456

Assessment of Non-invasive Tools for Detecting Active 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.

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Key information

Conditions

Inflammatory Bowel Disease (IBD) Colitis Colitis, Ulcerative Colonic Diseases Crohn Disease Crohn Disease (CD) Digestive System Diseases Disease Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Ulcerative Colitis (UC)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Sherbrooke, Quebec, J1H 5N4, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Scoring intestinal inflammation from stool protein analyses

    Time frame: 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 outcomes

  1. To compare activity scores deduced from proteomics analyses to the results from colonoscopy and pathology.

    Time frame: 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.

  2. To compare activity scores deduced from proteomics analyses to the results from pathology.

    Time frame: 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.

  3. To compare activity scores deduced from proteomics analyses to the results from fecal calprotectin.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Jean-François Beaulieu

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 9, 2024
Registry last updated
Dec 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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