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NCT05615116 Clinical Trial

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

Crohn Disease Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05615116
Other study ID # xkkb-2022
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date November 15, 2022
Est. completion date March 15, 2023

Study information
Verified date November 2022
Source Shanghai 10th People's Hospital
Contact Kai Xia, MM
Phone 13588251107
Email 987239945@qq.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 60
Est. completion date March 15, 2023
Est. primary completion date March 15, 2023
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
China Shanghai 10th People's Hospital Shanghai Shanghai

Sponsors (1)
Lead Sponsor Collaborator
Shanghai 10th People's Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Other Microbial changes of oral cavity 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
Primary Microbial changes of intestinal mucosa 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 Microbial changes of mesenteric adipose tissue 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
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