Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06538649
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-01
Brief Title:
Effect of Statins on Crohns Disease
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Determining the Therapeutic Potential of Statins on Stricturing Crohns Disease
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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:
None
Brief Summary:
Can statin use reduce the formation of Crohns strictures
Detailed Description:
Strictures are a formidable complication of Crohns disease CD with more than half of patients experiencing clinically significant bowel obstructions Stricturing CD is a primary driver of morbidity and hospital admissions and is frequently associated with treatment failures Moreover it is estimated that nearly 50 of patients with CD will undergo bowel resection surgery within ten years of diagnosis highlighting the severity and persistence of this issue for patients as well as the healthcare system
By modulating inflammatory and fibrotic pathways we posit that statins reduce primary stricture development and also recurrence after stricture resection
We will assess the impact of statin therapy on early stricture recurrence in a pilot randomized controlled clinical trial in patients undergoing stricture resection evaluating both clinical outcomes and detailed immune microbiome and metabolic profiling This aim will determine if statins reduce clinical and biological signs of stricture recurrence in the short term
By modulating inflammatory and fibrotic pathways we posit that statins reduce primary stricture development and also recurrence after stricture resection
We will assess the impact of statin therapy on early stricture recurrence in a pilot randomized controlled clinical trial in patients undergoing stricture resection evaluating both clinical outcomes and detailed immune microbiome and metabolic profiling This aim will determine if statins reduce clinical and biological signs of stricture recurrence in the short term
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