Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2026-01-09 @ 1:17 AM
Study NCT ID:
NCT05405634
Status:
UNKNOWN
Last Update Posted:
2022-06-06
First Post:
2022-05-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Microbiota in Chronic Anal Fissure and Its Association With Prognosis
Sponsor:
Lasse Krogsbøll
Organization:
Study Overview
Official Title:
Microbiota in Chronic Anal Fissure and Its Association With Prognosis - Prospective Cohort Study
Status:
UNKNOWN
Status Verified Date:
2022-06
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In this study, we will try to answer the following questions:
1. What are the salient features of the microbiota in chronic anal fissure?
2. Are these features associated with prognosis and response to therapy?
3. Does an anal fissure swab and anal fissure tissue give comparable bacteriological results?
1. What are the salient features of the microbiota in chronic anal fissure?
2. Are these features associated with prognosis and response to therapy?
3. Does an anal fissure swab and anal fissure tissue give comparable bacteriological results?
Detailed Description:
To allow rational planning of therapeutic trials of antimicrobial or biofilm degrading medical therapy, a better understanding of the microbiota of chronic anal fissures is needed. Previous studies have relied on culture, whereas we will employ molecular methods.
We will collect bacteriological samples from patients referred to us with anal fissure, in order to characterize the microbiota. To see if the microbiota is distinct from or similar to the rectal microbiota, we will also collect a swap from the rectum. We will also collect swaps from the anal verge of healthy volunteers without anal fissure, to see if the microbiota in anal fissures are distinct from the normal anodermal microbiota. To examine whether a swap is a reliable method for characterizing the microbiota in anal fissure, we will also collect excised anal fissure tissue from the subset of patients with a clinical indication for fissurectomy in general anaesthesia, and compare the analysis results with those from the swap.
We will re-assess the patients clinically and with a repeat swap after 3 months, and perform an exploratory analysis in order to identify possible features of the microbiota that are associated with poor response to therapy.
We will collect bacteriological samples from patients referred to us with anal fissure, in order to characterize the microbiota. To see if the microbiota is distinct from or similar to the rectal microbiota, we will also collect a swap from the rectum. We will also collect swaps from the anal verge of healthy volunteers without anal fissure, to see if the microbiota in anal fissures are distinct from the normal anodermal microbiota. To examine whether a swap is a reliable method for characterizing the microbiota in anal fissure, we will also collect excised anal fissure tissue from the subset of patients with a clinical indication for fissurectomy in general anaesthesia, and compare the analysis results with those from the swap.
We will re-assess the patients clinically and with a repeat swap after 3 months, and perform an exploratory analysis in order to identify possible features of the microbiota that are associated with poor response to therapy.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: