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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Perianal Abscess
• Intervention / Treatment: Procedure: surgical operation

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Sun Xingwei; Phone Number: +8613571818516; Email: 4866442@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Volunteers who did not keep the specimens as required

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Observation group: the structure and changes of rectal flora before and after treatment	Analysis of the intestinal microflora based on 16S rDNA amplicon sequencing	Two months
Control group: the structure and changes of rectal flora in healthy population	Analysis of the intestinal microflora based on 16S rDNA amplicon sequencing	Two months

Collaborators and Investigators

• Sponsor: Xi'an Hospital of Traditional Chinese Medicine

Study record dates

Study Major Dates

• Study Start (Anticipated): May 10, 2023
• Primary Completion (Anticipated): December 1, 2024
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: May 7, 2023
• First Submitted That Met QC Criteria: May 7, 2023
• First Posted (Actual): May 17, 2023

Study Record Updates

• Last Update Posted (Actual): May 17, 2023
• Last Update Submitted That Met QC Criteria: May 7, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Inflammation; Suppuration; Abscess
• Other Study ID Numbers: 2022SF-369

Drug and device information, study documents

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