Clincosm LogoSign in Get a demo

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

Sponsor
Shanghai 10th People's Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05615116
Collaborator
(none)
60
Enrollment
1
Location
3.9
Anticipated Duration (Months)
15.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    60 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Clinical Study on the Distribution of Digestive Tract Microbiota Before and After Ileocecal Resection in Crohn's Disease
    Anticipated Study Start Date :
    Nov 15, 2022
    Anticipated Primary Completion Date :
    Mar 15, 2023
    Anticipated Study Completion Date :
    Mar 15, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. Microbial changes of intestinal mucosa [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

    Secondary Outcome Measures

    1. Microbial changes of mesenteric adipose tissue [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

    Other Outcome Measures

    1. Microbial changes of oral cavity [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Shanghai 10th People's Hospital Shanghai Shanghai China 200072

    Sponsors and Collaborators

    • Shanghai 10th People's Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Huanlong Qin, Professor, Shanghai 10th People's Hospital
    ClinicalTrials.gov Identifier:
    NCT05615116
    Other Study ID Numbers:
    • xkkb-2022
    First Posted:
    Nov 14, 2022
    Last Update Posted:
    Nov 14, 2022
    Last Verified:
    Nov 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Crohn Disease
    Congenital Microtia

    Study Results

    No Results Posted as of Nov 14, 2022