Microflora and Metabolomics of Crohn's Disease Patients

July 12, 2021 updated by: Huanlong Qin, Shanghai 10th People's Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

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 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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Three different groups were created by healthy volunteers, patients with active Crohn's disease and patients with remission of Crohn's disease. The information of these individuals will be analyzed and some conclusions will be drawn.

Description

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 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
Active Crohn's disease group
Patients diagnosed with Crohn's disease after comprehensive evaluation of clinical symptoms, endoscopic features, radiological manifestations and histological features were recruited, and patients with CDAI score ≥ 150 were included in this group.
Crohn's disease remission group
Patients diagnosed with Crohn's disease after comprehensive evaluation of clinical symptoms, endoscopic features, radiological features and histological features were recruited, and patients with CDAI score < 150 were included in this group.
Healthy control group
Normal healthy people were randomly recruited as the control group

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

Shanghai 10th People's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

August 1, 2021

Primary Completion (Anticipated)

March 1, 2022

Study Completion (Anticipated)

July 31, 2022

Study Registration Dates

First Submitted

July 12, 2021

First Submitted That Met QC Criteria

July 12, 2021

First Posted (Actual)

July 16, 2021

Study Record Updates

Last Update Posted (Actual)

July 16, 2021

Last Update Submitted That Met QC Criteria

July 12, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHSYXK

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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