Inflammatory Bowel Disease (IBD)NCT06722456
Assessment of Non-invasive Tools for Detecting Active Inflammatory Bowel Disease
An observational study of Inflammatory Bowel Disease (IBD) and Crohn Disease (CD), run by Jean-François Beaulieu at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Disease (IBD), Crohn Disease (CD), Ulcerative Colitis (UC)
- What is being tested?
- Analysis of protein signatures in stool samples
- How many people
- 120 participants
- Where
- 1 siteCanada
- Study dates
- 30 May 2024to 15 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients followed by a gastroenterologist at the CIUSS de l'Estrie-CHUS.
Who may be able to join
- 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.
Who cannot join
- Having no history of inflammatory bowel disease.
- Be affected with an history of gastrointestinal disease other than Crohn disease or ulcerative colitis.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
Centre de recherche of the CIUSSS de l'Estrie-CHUS
Sherbrooke, Quebec, J1H 5N4
About this study
Official title: Set-up of Mass Spectrometry-based Stool Tests for Improving the Diagnosis and Management of 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.
Read more
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.
- Being tested
- Analysis of protein signatures in stool samples
- Keywords
- Diagnosis, Non-invasive, Remission
- Medical subject headings
- Inflammatory Bowel Diseases, Crohn Disease, Colitis, Ulcerative, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Analysis of protein signatures in stool samplesDiagnostic test
Stool protein signatures are to be established in parallel to standard clinical evaluation of the intestinal inflammatory activity.
| Study group | Role | What they receive |
|---|---|---|
| IBD in remission | Patient affected with an inflammatory bowel disease that is considered in remission. Receives: 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. Receives: 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. Receives: Diagnostic Test: Analysis of protein signatures in stool samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: From enrolment to the end of full data compilation, assessed up to 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2024
- Study start30 May 2024
- Primary completion30 Jun 2025 (estimated)
- Study completion15 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel Disease (IBD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jean-François Beaulieu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jean-François Beaulieu, Université de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06722456
- Sponsor's protocol ID
- 90-18A
- Status last verified
- Dec 2024
- First submitted
- 28 Nov 2024
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD that underlies results in a publication will be shared.
Publications
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.
PubMed 38397935
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Set-up of Mass Spectrometry-based Stool Tests for Improving the Diagnosis and Management of Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT06722456
- Acronym / sponsor ID
- 90-18A
- Keywords
- Diagnosis, Non-invasive, Remission
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Jean-François BeaulieuUniversity, hospital or other
- Study start
- 30 May 2024 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 15 Dec 2025 (estimated)
- First posted
- 9 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| IBD in remission | – | Diagnostic Test: Analysis of protein signatures in stool samplesPatient affected with an inflammatory bowel disease that is considered in remission. |
| IBD active | – | Diagnostic Test: Analysis of protein signatures in stool samplesPatient affected with an inflammatory bowel disease that is considered under an active state. |
| IBD not classified | – | Diagnostic Test: Analysis of protein signatures in stool samplesPatient affected with an inflammatory bowel disease that is difficult to classify as active or in remission. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients followed by a gastroenterologist at the CIUSS de l'Estrie-CHUS.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Having no history of inflammatory bowel disease.
- Be affected with an history of gastrointestinal disease other than Crohn disease or ulcerative colitis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Analysis of protein signatures in stool samplesStool protein signatures are to be established in parallel to standard clinical evaluation of the intestinal inflammatory activity. | Diagnostic test | IBD active, IBD in remission, IBD not classified |
Primary outcome
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).
3 secondary outcomes
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
- Background: PubMed 38397935Shajari 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.
- Laboratory webpage on research pertaining to inflammatory bowel disease.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. IPD that underlies results in a publication will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Disease (IBD) and Crohn Disease (CD), run by Jean-François Beaulieu at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scoring intestinal inflammation from stool protein analyses (time frame: From enrolment to the end of full data compilation, assessed up to 15 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06722456, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2024.