Crohn's Disease of Both Small and Large IntestineCIMPANCT06503081
Crohn's Disease - Inflammation and Microbial Proteolytic Activity
An observational study of Crohn's Disease of Both Small and Large Intestine, run by McMaster University at 1 site in Canada.
Trial summary
This study postulates that altered microbiota associated with areas of mucosal inflammation in CD, can be characterized by an increased proteolytic profile. This is clinically important as it may be possible to modulate the proteolytic activity of the CD-associated bacteria by using other bacteria that produce… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Crohn's Disease of Both Small and Large Intestine
- What is being tested?
- Colonoscopy
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 1 Dec 2019to 20 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study subjects will be invited to participate in the outpatient clinic if the clinical need for standard, white light colonoscopy has already been confirmed as well as a previous diagnosis of Crohn's disease. All study subjects will be enrolled into the study after informed consent
Who may be able to join
- Be aged between 18 - 70 years old
- Have a confirmed diagnosis of Crohn's disease
- Have a clinical indication for standard, white light colonoscopy to assess disease activity and extent
Who cannot join
- Inability to provide written informed consent
- Presence of serious life-threatening co-morbidities
- Evidence of toxic megacolon, jaundice, cirrhosis, renal dysfunction, acute GI bleeding
- History of difficult colonoscopy, strictures or extensive diverticulosis
- Antibiotics in the last month
- Probiotics in the last week
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigating the Relationship Between Inflammation and Proteolytic Activity From Mucosa-associated Microbiota in Crohn's Disease Patients
This study postulates that altered microbiota associated with areas of mucosal inflammation in CD, can be characterized by an increased proteolytic profile. This is clinically important as it may be possible to modulate the proteolytic activity of the CD-associated bacteria by using other bacteria that produce protease inhibitors, such as serpins.
Read the detailed description
Crohn's disease (CD), characterized by discontinuous intestinal injury and inflammation, has been associated with changes in the luminal microbiota and impaired barrier function. Previously, the investigators have shown that in patients with CD, the mucosa-associated microbiota is altered. Additionally, it has been shown that in patients with active CD, areas of intestinal injury are associated with impaired barrier function, but the mechanisms remain unclear. Increased host proteolytic activity has been reported in both CD and ulcerative colitis (UC). The microbiota is an important source of proteases with potential inflammatory and barrier disrupting capacity. Indeed, preliminary data indicate that in UC patients the gut microbiota contributes to proteolytic imbalance. It is unknown whether this is also the case in CD. Specifically, this study postulates that the altered microbiota associated with areas of mucosal inflammation in CD, is characterized by an increased proteolytic profile. This is clinically important as it may be possible to modulate the proteolytic activity of the CD-associated bacteria by using other bacteria that produce protease inhibitors such as serpins.
In this prospective observational study, patients booked for routine white light colonoscopy under the care of the Division of Gastroenterology, Hamilton Health Sciences at the McMaster University Medical Centre and Juravinski Hospital Endoscopy Units will be invited to participate. Patients previously diagnosed with Crohn's disease who have a clinical indication for undergoing a standard white light colonoscopy, as determined by the gastroenterologist, will be invited to participate; biopsy samples and mucosal brushings will be taken from inflamed and non-inflamed areas in the ileum or colon.
- Being tested
- Colonoscopy
- Keywords
- Proteolytic activity, Serpin, Crohn's disease
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColonoscopyProcedure or surgery
Colonoscopy with video recording and biopsy collection
| Study group | Role | What they receive |
|---|---|---|
| Crohn's disease | Patients previously diagnosed with Crohn's disease who have a clinical indication for undergoing a standard white light colonoscopy, as determined by their gastroenterologist, will be invited to participate. Patients undergoing colonoscopy for other indications (for example, for the investigation of possible malignancy, polyps, gastrointestinal bleeding or diarrhea, without colonic inflammation), will not be included in this study. Receives: Procedure: Colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Altered microbiota associated with areas of mucosal inflammation in CD, is characterized by an increased proteolytic profile
Increase proteolytic activity profile influenced by microbiota composition in inflamed areas comprared with non-inflamed areas in a context of Crohn's disease
Measured: December 2019 - January 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2024
- Study start1 Dec 2019
- Primary completion20 Feb 2025
- Study completion20 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Crohn's Disease of Both Small and Large IntestineStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Armstrong, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06503081
- Sponsor's protocol ID
- HiREB-7789
- Acronym
- CIMPA
- Status last verified
- Aug 2025
- First submitted
- 9 Jul 2024
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Xavier RJ, Podolsky DK. Unravelling the pathogenesis of inflammatory bowel disease. Nature. 2007 Jul 26;448(7152):427-34. doi: 10.1038/nature06005.
PubMed 17653185Bouma G, Strober W. The immunological and genetic basis of inflammatory bowel disease. Nat Rev Immunol. 2003 Jul;3(7):521-33. doi: 10.1038/nri1132.
PubMed 12876555Libertucci J, Dutta U, Kaur S, Jury J, Rossi L, Fontes ME, Shajib MS, Khan WI, Surette MG, Verdu EF, Armstrong D. Inflammation-related differences in mucosa-associated microbiota and intestinal barrier function in colonic Crohn's disease. Am J Physiol Gastrointest Liver Physiol. 2018 Sep 1;315(3):G420-G431. doi: 10.1152/ajpgi.00411.2017. Epub 2018 May 31.
PubMed 29848021Denadai-Souza A, Bonnart C, Tapias NS, Marcellin M, Gilmore B, Alric L, Bonnet D, Burlet-Schiltz O, Hollenberg MD, Vergnolle N, Deraison C. Functional Proteomic Profiling of Secreted Serine Proteases in Health and Inflammatory Bowel Disease. Sci Rep. 2018 May 18;8(1):7834. doi: 10.1038/s41598-018-26282-y.
PubMed 29777136Vergnolle N. Protease inhibition as new therapeutic strategy for GI diseases. Gut. 2016 Jul;65(7):1215-24. doi: 10.1136/gutjnl-2015-309147. Epub 2016 Apr 12.
PubMed 27196587Motta JP, Magne L, Descamps D, Rolland C, Squarzoni-Dale C, Rousset P, Martin L, Cenac N, Balloy V, Huerre M, Frohlich LF, Jenne D, Wartelle J, Belaaouaj A, Mas E, Vinel JP, Alric L, Chignard M, Vergnolle N, Sallenave JM. Modifying the protease, antiprotease pattern by elafin overexpression protects mice from colitis. Gastroenterology. 2011 Apr;140(4):1272-82. doi: 10.1053/j.gastro.2010.12.050. Epub 2011 Jan 1.
PubMed 21199654Caminero A, McCarville JL, Galipeau HJ, Deraison C, Bernier SP, Constante M, Rolland C, Meisel M, Murray JA, Yu XB, Alaedini A, Coombes BK, Bercik P, Southward CM, Ruf W, Jabri B, Chirdo FG, Casqueiro J, Surette MG, Vergnolle N, Verdu EF. Duodenal bacterial proteolytic activity determines sensitivity to dietary antigen through protease-activated receptor-2. Nat Commun. 2019 Mar 13;10(1):1198. doi: 10.1038/s41467-019-09037-9.
PubMed 30867416
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Relationship Between Inflammation and Proteolytic Activity From Mucosa-associated Microbiota in Crohn's Disease Patients
- ClinicalTrials.gov ID
- NCT06503081
- Acronym / sponsor ID
- CIMPA / HiREB-7789
- Keywords
- Proteolytic activity, Serpin, Crohn's disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 20 Feb 2025 (actual)
- Study completion
- 20 Feb 2025 (actual)
- First posted
- 16 Jul 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.
This study postulates that altered microbiota associated with areas of mucosal inflammation in CD, can be characterized by an increased proteolytic profile. This is clinically important as it may be possible to modulate the proteolytic activity of the CD-associated bacteria by using other bacteria that produce protease inhibitors, such as serpins.
Detailed description
Crohn's disease (CD), characterized by discontinuous intestinal injury and inflammation, has been associated with changes in the luminal microbiota and impaired barrier function. Previously, the investigators have shown that in patients with CD, the mucosa-associated microbiota is altered. Additionally, it has been shown that in patients with active CD, areas of intestinal injury are associated with impaired barrier function, but the mechanisms remain unclear. Increased host proteolytic activity has been reported in both CD and ulcerative colitis (UC). The microbiota is an important source of proteases with potential inflammatory and barrier disrupting capacity. Indeed, preliminary data indicate that in UC patients the gut microbiota contributes to proteolytic imbalance. It is unknown whether this is also the case in CD. Specifically, this study postulates that the altered microbiota associated with areas of mucosal inflammation in CD, is characterized by an increased proteolytic profile. This is clinically important as it may be possible to modulate the proteolytic activity of the CD-associated bacteria by using other bacteria that produce protease inhibitors such as serpins.
In this prospective observational study, patients booked for routine white light colonoscopy under the care of the Division of Gastroenterology, Hamilton Health Sciences at the McMaster University Medical Centre and Juravinski Hospital Endoscopy Units will be invited to participate. Patients previously diagnosed with Crohn's disease who have a clinical indication for undergoing a standard white light colonoscopy, as determined by the gastroenterologist, will be invited to participate; biopsy samples and mucosal brushings will be taken from inflamed and non-inflamed areas in the ileum or colon.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Crohn's disease | – | Procedure: ColonoscopyPatients previously diagnosed with Crohn's disease who have a clinical indication for undergoing a standard white light colonoscopy, as determined by their gastroenterologist, will be invited to participate. Patients undergoing colonoscopy for other indications (for example, for the investigation of possible malignancy, polyps, gastrointestinal bleeding or diarrhea, without colonic inflammation), will not be included in this study. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study subjects will be invited to participate in the outpatient clinic if the clinical need for standard, white light colonoscopy has already been confirmed as well as a previous diagnosis of Crohn's disease. All study subjects will be enrolled into the study after informed consent
Key inclusion criteria (3 listed)
- Be aged between 18 - 70 years old
- Have a confirmed diagnosis of Crohn's disease
- Have a clinical indication for standard, white light colonoscopy to assess disease activity and extent
Key exclusion criteria (6 listed)
- Inability to provide written informed consent
- Presence of serious life-threatening co-morbidities
- Evidence of toxic megacolon, jaundice, cirrhosis, renal dysfunction, acute GI bleeding
- History of difficult colonoscopy, strictures or extensive diverticulosis
- Antibiotics in the last month
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 |
|---|---|---|
| ColonoscopyColonoscopy with video recording and biopsy collection | Procedure or surgery | Crohn's disease |
Primary outcome
Altered microbiota associated with areas of mucosal inflammation in CD, is characterized by an increased proteolytic profile
Time frame: December 2019 - January 2025
Increase proteolytic activity profile influenced by microbiota composition in inflamed areas comprared with non-inflamed areas in a context of Crohn's disease
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- Background: PubMed 17653185Xavier RJ, Podolsky DK. Unravelling the pathogenesis of inflammatory bowel disease. Nature. 2007 Jul 26;448(7152):427-34. doi: 10.1038/nature06005.
- Background: PubMed 12876555Bouma G, Strober W. The immunological and genetic basis of inflammatory bowel disease. Nat Rev Immunol. 2003 Jul;3(7):521-33. doi: 10.1038/nri1132.
- Background: PubMed 29848021Libertucci J, Dutta U, Kaur S, Jury J, Rossi L, Fontes ME, Shajib MS, Khan WI, Surette MG, Verdu EF, Armstrong D. Inflammation-related differences in mucosa-associated microbiota and intestinal barrier function in colonic Crohn's disease. Am J Physiol Gastrointest Liver Physiol. 2018 Sep 1;315(3):G420-G431. doi: 10.1152/ajpgi.00411.2017. Epub 2018 May 31.
- Background: PubMed 29777136Denadai-Souza A, Bonnart C, Tapias NS, Marcellin M, Gilmore B, Alric L, Bonnet D, Burlet-Schiltz O, Hollenberg MD, Vergnolle N, Deraison C. Functional Proteomic Profiling of Secreted Serine Proteases in Health and Inflammatory Bowel Disease. Sci Rep. 2018 May 18;8(1):7834. doi: 10.1038/s41598-018-26282-y.
- Background: PubMed 27196587Vergnolle N. Protease inhibition as new therapeutic strategy for GI diseases. Gut. 2016 Jul;65(7):1215-24. doi: 10.1136/gutjnl-2015-309147. Epub 2016 Apr 12.
- Background: PubMed 21199654Motta JP, Magne L, Descamps D, Rolland C, Squarzoni-Dale C, Rousset P, Martin L, Cenac N, Balloy V, Huerre M, Frohlich LF, Jenne D, Wartelle J, Belaaouaj A, Mas E, Vinel JP, Alric L, Chignard M, Vergnolle N, Sallenave JM. Modifying the protease, antiprotease pattern by elafin overexpression protects mice from colitis. Gastroenterology. 2011 Apr;140(4):1272-82. doi: 10.1053/j.gastro.2010.12.050. Epub 2011 Jan 1.
- Background: PubMed 30867416Caminero A, McCarville JL, Galipeau HJ, Deraison C, Bernier SP, Constante M, Rolland C, Meisel M, Murray JA, Yu XB, Alaedini A, Coombes BK, Bercik P, Southward CM, Ruf W, Jabri B, Chirdo FG, Casqueiro J, Surette MG, Vergnolle N, Verdu EF. Duodenal bacterial proteolytic activity determines sensitivity to dietary antigen through protease-activated receptor-2. Nat Commun. 2019 Mar 13;10(1):1198. doi: 10.1038/s41467-019-09037-9.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
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 Crohn's Disease of Both Small and Large Intestine, run by McMaster University 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 3 inclusion and 6 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: finished, as of the sponsor's last update on 22 Aug 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Altered microbiota associated with areas of mucosal inflammation in CD, is characterized by an increased proteolytic profile (time frame: December 2019 - January 2025). 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 NCT06503081, which also lists 7 linked publications.
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 22 Aug 2025; AzTrials last refreshed its copy on 2 Nov 2026.