Crohn's Disease - Inflammation and Microbial Proteolytic Activity

NCT06503081 | Completed

• 1 other identifier: HiREB-7789
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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 protease inhibitors, such as serpins.

Conditions

Crohn's Disease of Both Small and Large Intestine

Keywords

Proteolytic activity; Serpin; Crohn's disease

Outcome Measures

Primary Outcomes (1)

• 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

  December 2019 - January 2025

Study Arms (1)

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.

Procedure: Colonoscopy

Interventions

Colonoscopy PROCEDURE

Colonoscopy with video recording and biopsy collection

Crohn's disease

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• McMaster University: lead

Study Sites (1)

McMaster University

Hamilton, Ontario, L8N 3Z5, Canada

Location

Related Publications (7)

• Xavier RJ, Podolsky DK. Unravelling the pathogenesis of inflammatory bowel disease. Nature. 2007 Jul 26;448(7152):427-34. doi: 10.1038/nature06005.

  PMID: 17653185 BACKGROUND

• Bouma 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.

  PMID: 12876555 BACKGROUND

• Libertucci 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.

  PMID: 29848021 BACKGROUND

• Denadai-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.

  PMID: 29777136 BACKGROUND

• Vergnolle 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.

  PMID: 27196587 BACKGROUND

• Motta 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.

  PMID: 21199654 BACKGROUND

• Caminero 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.

  PMID: 30867416 BACKGROUND

MeSH Terms

Conditions

Crohn Disease

Interventions

Colonoscopy

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: July 9, 2024
• First Posted: July 16, 2024
• Study Start: December 1, 2019
• Primary Completion: February 20, 2025
• Study Completion: February 20, 2025
• Last Updated: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)