ClinicalTrials.gg
CompletedNCT05862129Updated Jan 7, 2025

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

An observational study in Perianal Abscess, sponsored by Xi'an Hospital of Traditional Chinese Medicine. Completed at 1 site in China. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-07.

Sponsored by Xi'an Hospital of Traditional Chinese Medicine · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
100
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Perianal Abscess

Browse trials for

03

In context

Abscess

152 studies on the registry are indexed under Abscess; 22 are open to participants now.

This study's enrollment of 100 is close to the median of 100 across 24 observational studies indexed under Abscess.

Browse Abscess studies →

Lead sponsor

Xi'an Hospital of Traditional Chinese Medicine is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Volunteers who did not keep the specimens as required

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 .

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

Exclusion Criteria:

  • Failing to retain the specimens as required
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
100 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • control group

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

Interventions

  • Proceduresurgical operation

    Radical operation for the perianal abscess

06

What researchers measure

Primary outcomes

  1. Observation group: the structure and changes of rectal flora before and after treatment

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

    Time frame: Two months

  2. Control group: the structure and changes of rectal flora in healthy population

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

    Time frame: Two months

07

Study locations

1 site
  • Xi'an Hospital of Traditional Chinese Medicine
    Xi'an City, Shaanxi 710021, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 7, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05862129
Lead sponsor
Xi'an Hospital of Traditional Chinese Medicine
Responsible party
Sponsor
First posted
May 17, 2023
Start date
Jun 1, 2023
Primary completion
Jun 30, 2024
Completion
Jun 30, 2024
Last update
Jan 7, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion