Microflora and Metabolomics of Crohn's Disease Patients

NCT04965584 | Unknown

• 1 other identifier: SHSYXK
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Crohn Disease

Keywords

Crohn's disease; microbiota; metabonomics

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (1)

• Metabolic difference of blood samples between active stage of Crohn's disease, remission of Crohn's disease and healthy controls

  3 months

Study Arms (3)

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Shanghai 10th People's Hospital: lead

Study Sites (1)

Shanghai 10th People's Hospital

Shanghai, Shanghai Municipality, 200072, China

Location

Related Publications (1)

• Xia K, Gao R, Wu X, Sun J, Wan J, Wu T, Fichna J, Yin L, Chen C. Characterization of Specific Signatures of the Oral Cavity, Sputum, and Ileum Microbiota in Patients With Crohn's Disease. Front Cell Infect Microbiol. 2022 Apr 13;12:864944. doi: 10.3389/fcimb.2022.864944. eCollection 2022.

  PMID: 35493739 DERIVED

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Central Study Contacts

Kai Xia, MM

CONTACT

13588251107; 987239945@qq.com

Renyuan Gao, MD

CONTACT

15601675695; renyuangao@126.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 12, 2021
• First Posted: July 16, 2021
• Study Start: August 1, 2021
• Primary Completion: March 1, 2022
• Study Completion: July 31, 2022
• Last Updated: July 16, 2021

Record last verified: 2021-07

Locations

CN (1)