Perianal AbscessNCT05862129
Association of Intestinal Microbiota and the Onset of Perianal Abscess Based on 16S RDNA Amplicon Sequencing
An observational study of Perianal Abscess, run by Xi'an Hospital of Traditional Chinese Medicine at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Perianal Abscess
- What is being tested?
- surgical operation
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2023to 30 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Volunteers who did not keep the specimens as required
Who may be able to join
- 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.
Who cannot join
- Failing to retain the specimens as required
Trial locations and contacts
1 site in 1 country.
China1 site
Xi'an Hospital of Traditional Chinese Medicine
Xi'an, Shaanxi, 710021
About this study
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.
- Conditions
- Perianal Abscess
- Being tested
- surgical operation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgical operationProcedure or surgery
Radical operation for the perianal abscess
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: surgical operation | |
| control group | This group collected rectal secretions and stool specimens from a healthy population. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Observation group: the structure and changes of rectal flora before and after treatment
Analysis of the intestinal microflora based on 16S rDNA amplicon sequencing
Measured: 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
Measured: Two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2023
- Study start1 Jun 2023
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perianal AbscessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xi'an Hospital of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05862129
- Sponsor's protocol ID
- 2022SF-369
- Status last verified
- Dec 2024
- First submitted
- 7 May 2023
- Last updated
- 7 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Intestinal Microbiota and the Onset of Perianal Abscess Based on 16S RDNA Amplicon Sequencing
- ClinicalTrials.gov ID
- NCT05862129
- Acronym / sponsor ID
- 2022SF-369
- Conditions
- Perianal Abscess
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Xi'an Hospital of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 17 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| observation group | – | Procedure: surgical operationThis 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. |
| control group | – | –This group collected rectal secretions and stool specimens from a healthy population. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Volunteers who did not keep the specimens as required
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Failing to retain the specimens as required
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| surgical operationRadical operation for the perianal abscess | Procedure or surgery | observation group |
Primary outcome
Observation group: the structure and changes of rectal flora before and after treatment
Time frame: Two months
Analysis of the intestinal microflora based on 16S rDNA amplicon sequencing
Control group: the structure and changes of rectal flora in healthy population
Time frame: Two months
Analysis of the intestinal microflora based on 16S rDNA amplicon sequencing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Perianal Abscess, run by Xi'an Hospital of Traditional Chinese Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Observation group: the structure and changes of rectal flora before and after treatment (time frame: Two months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2025.