Association of Intestinal Microbiota and the Onset of Perianal Abscess Based on 16S rDNA Amplicon Sequencing

Sponsor
Xi'an Hospital of Traditional Chinese Medicine (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05862129
Collaborator
(none)
100
18.8

Study Details

Study Description

Brief Summary

The goal of this observational study is tolearn the association of gut microflora with the onset of perianal abscesses. The main questions it aims to answer are:

Question 1: To understand the structure of rectal microbial community composition and its relationship with pathogenic bacteria in patients with perianal abscess.

Question 2: Understand the structure of rectal microbial community composition in healthy people.

Participants will be collected with rectal secretions and stool specimens.In addition, patients with perianal abscess should also collect pus samples.

Condition or Disease Intervention/Treatment Phase
  • Procedure: surgical operation

Study Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Association of Intestinal Microbiota and the Onset of Perianal Abscess Based on 16S rDNA Amplicon Sequencing
Anticipated Study Start Date :
May 10, 2023
Anticipated Primary Completion Date :
Dec 1, 2024
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

Arm Intervention/Treatment
observation group

This group will collect rectal secretions and stool samples and pus samples from patients with perianal abscess before treatment, and collect rectal secretions and stool samples from patients again 2 months after treatment according to the diagnosis and treatment guidelines.

Procedure: surgical operation
Radical operation for the perianal abscess

control group

This group collected rectal secretions and stool specimens from a healthy population.

Outcome Measures

Primary Outcome Measures

  1. Observation group: the structure and changes of rectal flora before and after treatment [Two months]

    Analysis of the intestinal microflora based on 16S rDNA amplicon sequencing

  2. Control group: the structure and changes of rectal flora in healthy population [Two months]

    Analysis of the intestinal microflora based on 16S rDNA amplicon sequencing

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Observation group: ① Age between 18-60 years, local resident of Xi'an; ② met the diagnostic criteria for perianal abscess and underwent surgical treatment in our hospital; ③ did not use antibiotics before treatment; ④ himself and his family members were willing to participate in this study and signed informed consent.

Control group: ① Age between 18-60 years, permanent residents in Xi'an; ② had no serious chronic disease, no abnormality in physical examination in the last 1 week; ③ did not use drugs that may affect intestinal flora in the last one month; ④ himself and his family members are willing to participate in the study and sign the informed consent.

Exclusion Criteria:
  • Failing to retain the specimens as required

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Xi'an Hospital of Traditional Chinese Medicine

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Xi'an Hospital of Traditional Chinese Medicine
ClinicalTrials.gov Identifier:
NCT05862129
Other Study ID Numbers:
  • 2022SF-369
First Posted:
May 17, 2023
Last Update Posted:
May 17, 2023
Last Verified:
May 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 17, 2023