Clinical Study on the Distribution of Digestive Tract Microbiota Before and After Ileocecal Resection in Crohn's Disease

November 11, 2022 updated by: Huanlong Qin, Shanghai 10th People's Hospital
In this study, the microbiota sequencing was used to investigate the changes of microbiota in the terminal ileum and the middle part of ascending colon, the mesenteric adipose tissue of ileum and ascending mesocolon, and oral cavity of patients with Crohn's disease before and after ileocecal resection, so as to further explore the role of ileocecal region in inducing remission of disease.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

60

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
    • Shanghai
      • Shanghai, Shanghai, China, 200072
        • Shanghai 10th People's Hospital

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

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Crohn's patients before and after ileocecal resection were divided into two groups， the information of these individuals will be analyzed and some conclusions will be drawn.

Description

Inclusion Criteria:

Clinical diagnosis of Crohn's disease

Exclusion Criteria:

Serious oral diseases (e.g. dental caries, periodontal disease) Other acute or chronic gastrointestinal diseases Probiotics or prebiotic consumption and antibiotic use within 1 month

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
Before ileocecal resection
Patients diagnosed with Crohn's disease after comprehensive evaluation of clinical symptoms, endoscopic features, radiological manifestations and histological features were recruited，and the patients were admitted for right hemicolectomy
After ileocecal resection
Patients diagnosed with Crohn's disease after comprehensive evaluation of clinical symptoms, endoscopic features, radiological manifestations and histological features were recruited，and the patients underwent reversal of ileostoma after right hemicolectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Microbial changes of intestinal mucosa
Time Frame: 6 month
Explore the microbial changes in the mucosa of the terminal ileum and the middle segment of the ascending colon in patients with Crohn's disease before and after ileocecal resection through metagenomic analysis
6 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Microbial changes of mesenteric adipose tissue
Time Frame: 6 month
Explore the microbial changes in the mesenteric adipose tissue of the terminal ileum and the middle segment of the ascending colon in patients with Crohn's disease before and after ileocecal resection through metagenomic analysis
6 month

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Microbial changes of oral cavity
Time Frame: 6 month
Explore the microbial changes in the buccal region of oral cavity in patients with Crohn's disease before and after ileocecal resection through metagenomic analysis
6 month

Collaborators and Investigators

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

Sponsor

Shanghai 10th People's Hospital

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 (ANTICIPATED)

November 15, 2022

Primary Completion (ANTICIPATED)

March 15, 2023

Study Completion (ANTICIPATED)

March 15, 2023

Study Registration Dates

First Submitted

November 5, 2022

First Submitted That Met QC Criteria

November 11, 2022

First Posted (ACTUAL)

November 14, 2022

Study Record Updates

Last Update Posted (ACTUAL)

November 14, 2022

Last Update Submitted That Met QC Criteria

November 11, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • xkkb-2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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