Microflora and Metabolomics of Crohn's Disease Patients

Crohn Disease Clinical Trial

Official title:

A Study Focused on the Microflora and Metabolomics of Crohn's Disease Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04965584
• Other study ID #: SHSYXK
• Status: Not yet recruiting
• Start date: August 1, 2021
• Est. completion date: July 31, 2022

Study information

• Verified date: July 2021
• Source: Shanghai 10th People's Hospital
• Contact: Kai Xia, MM
• Phone: 13588251107
• Email: 987239945[@]qq.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: July 31, 2022
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Crohn Disease

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
Primary	Oral microbiota structure and function difference between active stage of Crohn's disease, remission of Crohn's disease and healthy controls	The results were based on the 16S rRNA sequencing	3 months
Primary	Small intestinal microbiota structure and function difference between active stage of Crohn's disease, remission of Crohn's disease and healthy controls	The results were based on the 16S rRNA sequencing	3 months
Primary	Sputum microbiota structure and function difference between active stage of Crohn's disease, remission of Crohn's disease and healthy controls	The results were based on the 16S rRNA sequencing	3 months
Secondary	Metabolic difference of blood samples between active stage of Crohn's disease, remission of Crohn's disease and healthy controls	The metabolites of the blood samples by LC-MS will be detected	3 months