Microbiota in Chronic Anal Fissure and Its Association With Prognosis

Microbial Colonization Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05405634
• Other study ID #: Microbiota in anal fissure
• Status: Not yet recruiting
• Start date: September 2022
• Est. completion date: June 2023

Study information

• Verified date: June 2022
• Source: Bispebjerg Hospital
• Contact: Lasse T Krogsbøll, MD, PhD
• Phone: 0045 51684692
• Email: lasse.theis.krogsboell[@]regionh.dk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: June 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anal Fissure
• Communicable Diseases
• Fissure in Ano
• Infections
• Microbial Colonization

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Lasse Krogsbøll

Outcome

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