Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06503081
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-09
Brief Title:
Crohns Disease - Inflammation and Microbial Proteolytic Activity
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Investigating the Relationship Between Inflammation and Proteolytic Activity From Mucosa-associated Microbiota in Crohns Disease Patients
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CIMPA
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
Detailed Description:
Crohns 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 Crohns 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
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 Crohns 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None