Microflora and Metabolomics of Crohn's Disease Patients

• Conditions: Crohn Disease

• Registration Number: NCT04965584
• Lead Sponsor: Shanghai 10th People's Hospital

Brief Summary

The purpose of this study is to explore the microflora characteristics of different ecological loci and multiple metabolic pathways in Crohn's disease patients with different disease course states.

Detailed Description

This study aims to investigate the characteristics of microflora in the oral and tongue base, small intestinal stomy and lower respiratory tract, as well as the characteristics of multiple metabolic pathways such as bile acid metabolism and amino acid metabolism in Crohn's disease patients with different course states.

Study Timeline

• Status Verified: 2021-07
• Study First Submitted: 2021-07-12
• Study First Submitted QC: 2021-07-12
• Last Update Submitted: 2021-07-12
• Study First Posted: 2021-07-16
• Last Update Posted: 2021-07-16
• Study Start: 2021-08-01
• Primary Completion: 2022-03-01
• Study Completion: 2022-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. individuals who were clear and signed the informed consent.
2. Male and female.

Exclusion Criteria

1. Any one who can not provide accurate information.
2. Any one who denies the study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Oral microbiota structure and function difference between active stage of Crohn's disease, remission of Crohn's disease and healthy controls	3 months	The results were based on the 16S rRNA sequencing
Sputum microbiota structure and function difference between active stage of Crohn's disease, remission of Crohn's disease and healthy controls	3 months	The results were based on the 16S rRNA sequencing
Small intestinal microbiota structure and function difference between active stage of Crohn's disease, remission of Crohn's disease and healthy controls	3 months	The results were based on the 16S rRNA sequencing

Secondary Outcome Measures

Name	Time	Method
Metabolic difference of blood samples between active stage of Crohn's disease, remission of Crohn's disease and healthy controls	3 months	The metabolites of the blood samples by LC-MS will be detected

Trial Locations

Locations (1)

Shanghai 10th People's Hospital; 🇨🇳 Shanghai, Shanghai, China