The Diversity of the Fungal and Bacterial in Colon Mucosa of Patients With Different Degree of Inflammation of Ulcerative Colitis

May 10, 2017 updated by: Xiuli Zuo

The Diversity of the Fungal and Bacterial in Colon Mucosa of Patients With Ulcerative Colitis Associated Different Clinical Classification

We analyzed the diversity of the fungal and bacterial within colon mucosa between patients with different degree of inflammation of Ulcerative Colitis.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

In recent years, the relationship of intestinal fungus with inflammatory bowel disease was gradually revealed. We divided the patients with ulcerative colitis into three groups on the basis of World Gastroenterology Organisation (WGO) classification about inflammation degree and progress classification and established the healthy control group. Analyzing the diversity of the fungal and bacterial within colon mucosa between patients with different clinical classification, for example, the proportion of bacteria and fungi, the proportion of candida albicans, the proportion of yeasts, and so on.

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250012
        • Recruiting
        • Qilu Hospital, Shandong University
        • Contact:
        • Sub-Investigator:
          • Lidong Xu, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Consecutive patients under endoscopic surveillance or examination at Qilu Hospital were considered for inclusion.

Description

Inclusion Criteria:

  • Patients at our tertiary care medical center, aged between 18 and 80 years, scheduled to undergo surveillance colonoscopy.
  • The patients with ulcerative colitis for ulcerative colitis group.
  • The patients without ulcerative colitis for control group.
  • 18-80 years.

Exclusion Criteria:

  • Using antibiotics, glucocorticoid and immunosuppressants wintin one month.
  • There are contraindications for enteroscopy and biopsy.
  • There are other intestinal diseases.
  • Pregnancy or breast-feeding women.
  • Patients with serious lung disease and mental illness.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
ulcerative colitis
We analysed the diversity of the fungal and bacterial in patients with Ulcerative Colitis (UC). We take 2 pieces of biopsies in the sigmoid colon mucosa inflammation area during the colonoscopy and then perform gene sequencing.
Other: ulcerative colitis
We take 2 pieces of biopsies in the sigmoid colon mucosa inflammation area during the colonoscopy and then perform gene sequencing.
Other Names:
  • Patients With ulcerative colitis
Control
Analysing the diversity of the fungal and bacterial in patients without ulcerative colitis. We take 2 pieces of biopsies in the sigmoid colon mucosa during the colonoscopy and then perform gene sequencing.
Other: Control
We take 2 pieces of biopsies in the sigmoid colon mucosa during the colonoscopy and then perform gene sequencing.
Other Names:
  • Patients Without ulcerative colitis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
fungus detection rate
Time Frame: 6 months
Fungi detection rate was defined as the percentage of patients in whose colonic mucosa at least one kind of fungus were identified.
6 months
yeasts detection rate
Time Frame: 6 months
Yeasts detection rate was defined as the percentage of patients in whose colonic mucosa yeasts were identified.
6 months
candida albicans detection rate
Time Frame: 6 months
Candida albicans detection rate was defined as the percentage of patients in whose colonic mucosa candida albicans were identified.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xiuli Zuo

Collaborators

Qilu Hospital of Shandong University

Investigators

  • Principal Investigator: Xiuli Zuo, PhD, Qilu Hospital of Shandong University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (Anticipated)

August 1, 2017

Study Completion (Anticipated)

August 1, 2017

Study Registration Dates

First Submitted

December 19, 2016

First Submitted That Met QC Criteria

May 10, 2017

First Posted (Actual)

May 12, 2017

Study Record Updates

Last Update Posted (Actual)

May 12, 2017

Last Update Submitted That Met QC Criteria

May 10, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015SDU-QILU-G004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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