Microbiota in Chronic Anal Fissure and Its Association With Prognosis

NCT05405634 | Unknown

• 1 other identifier: Microbiota in anal fissure
• Study Type: observational
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

In this study, we will try to answer the following questions:

1. 1.What are the salient features of the microbiota in chronic anal fissure?
2. 2.Are these features associated with prognosis and response to therapy?
3. 3.Does an anal fissure swab and anal fissure tissue give comparable bacteriological results?

Conditions

Anal Fissure; Microbial Colonization

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (3)

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.

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

As above.

You may qualify if:

• Three samples will be included:
• 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
• Consecutive patients with an indication for revision of the fissure and anal injection of botulinum toxin in general anaesthesia
• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Lasse Krogsbøll: lead

Biospecimen

Retention: SAMPLES WITH DNA

Swab from anal fissure/anoderm and rectum, and tissue removed by fissurectomy.

MeSH Terms

Conditions

Fissure in Ano; Communicable Diseases

Condition Hierarchy (Ancestors)

Anus Diseases; Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Lasse T Krogsbøll, MD, PhD

  Digestive disease center, Bispebjerg Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lasse T Krogsbøll, MD, PhD

CONTACT

0045 51684692; lasse.theis.krogsboell@regionh.dk

Andreas Nordholm-Carstensen, MD, PhD

CONTACT

andreas.nordholm-carstensen@regionh.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor-investigator

Study Record Dates

• First Submitted: May 20, 2022
• First Posted: June 6, 2022
• Study Start: September 1, 2022
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: June 6, 2022

Record last verified: 2022-06