Microbiota in Chronic Anal Fissure and Its Association With Prognosis

Microbiota in Chronic Anal Fissure and Its Association With Prognosis - Prospective Cohort Study

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?

Study Overview

• Status: Not yet recruiting
• Conditions: Microbial Colonization; Anal Fissure

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.

• Study Type: Observational
• Enrollment (Anticipated): 80

Contacts and Locations

• Study Contact: Name: Lasse T Krogsbøll, MD, PhD; Phone Number: 0045 28700717 0045 51684692; Email: lasse.theis.krogsboell@regionh.dk
• Study Contact Backup: Name: Andreas Nordholm-Carstensen, MD, PhD; Email: andreas.nordholm-carstensen@regionh.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

As above.

Description

Inclusion criteria

Three samples will be included:

1. Consecutive patients referred to the outpatient clinic at the Digestive Disease Centre, Bispebjerg Hospital in Denmark for botox injection for chronic anal fissure. Thus, the included patients will likely all have tried conservative treatment before referral, and are expected to represent a more homogeneous subset with longer standing disease, less spontaneous improvement, and a higher likelihood of being compliant with suggested therapy
2. Consecutive patients with an indication for revision of the fissure and anal injection of botulinum toxin in general anaesthesia
3. Healthy volunteers. These will be recruited among staff at the Digestive Disease Centre, Bispebjerg Hospital, Denmark.

Samples 1 and 2 will not be independent, as patients from group 1 may be included in group 2 depending on the clinical course. No direct comparisons between these two groups are planned (see analysis section).

Exclusion criteria

• Symptom duration of less than 8 weeks (groups 1 and 2)
• Known or suspected Crohn's disease
• Known or suspected active venereal disease.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Patients with chronic analfissure; 1. Consecutive patients referred to the outpatient clinic at the Digestive Disease Centre, Bispebjerg Hospital in Denmark for botox injection for chronic anal fissure. Thus, the included patients will likely all have tried conservative treatment before referral, and are expected to represent a more homogeneous subset with longer standing disease, less spontaneous improvement, and a higher likelihood of being compliant with suggested therapy
Patients with an indication for fissurectomy; Consecutive patients with an indication for revision of the fissure and anal injection of botulinum toxin in general anaesthesia
Healthy volunteers; Healthy volunteers. These will be recruited among staff at the Digestive Disease Centre, Bispebjerg Hospital, Denmark.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
16S/18S RNA		Baseline
16S/18S RNA		3 months
PICRUSt2		Baseline
PICRUSt2		3 months
Healing of anal fissure after 3 months	Defined by complete patient-reported resolution of pain combined with healed fissure on clinical examination	3 months
Change from baseline in pain severity both during and after defecation	Numerical rating scale 1-10.	3 months

Collaborators and Investigators

• Sponsor: Lasse Krogsbøll
• Investigators: Principal Investigator: Lasse T Krogsbøll, MD, PhD, Digestive Disease Center, Bispebjerg Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2022
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: May 20, 2022
• First Submitted That Met QC Criteria: June 2, 2022
• First Posted (Actual): June 6, 2022

Study Record Updates

• Last Update Posted (Actual): June 6, 2022
• Last Update Submitted That Met QC Criteria: June 2, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease Attributes; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Anus Diseases; Infections; Communicable Diseases; Fissure in Ano
• Other Study ID Numbers: Microbiota in anal fissure

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No