NCT06722456Enrolling by invitation
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
Source: ClinicalTrials.gov · Last updated 9 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Observational
- Enrollment
- 120 (estimated)
- First submitted
- 28 Nov 2024
- Start date
- 30 May 2024
- Primary completion date
- 30 Jun 2025
- Lead sponsor
- Jean-François Beaulieu
- Diseases
- Crohn's disease, Ulcerative colitis
- NCT number
- NCT06722456
What you commit to
- Study type: Observational
- Planned participants: 120
- From 30 May 2024 to the primary completion date, 30 Jun 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Having no history of inflammatory bowel disease.
- Be affected with an history of gastrointestinal disease other than Crohn disease or ulcerative colitis.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre de recherche of the CIUSSS de l'Estrie-CHUS Coordinator of this site? Confirm its status | Sherbrooke | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.