CD Patients Immune Status Evaluation

Completed

• Conditions: Severe Crohn's Diease
• Interventions: Other: colonic tissue biopsy

• Registration Number: NCT04135482
• Lead Sponsor: First Affiliated Hospital of Zhejiang University

Brief Summary

Using single cell sequencing method to evaluate and compare the immune status of patients with severe CD.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-10
• Study First Submitted: 2019-10-20
• Study First Submitted QC: 2019-10-20
• Study Start: 2019-10-21
• Study First Posted: 2019-10-22
• Primary Completion: 2020-07-15
• Study Completion: 2020-07-31
• Last Update Submitted: 2023-02-16
• Last Update Posted: 2023-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

1, Patients with severe CD（CDAI>16,SES-CD>19） 2, Patients have no previous any drug therapy targeting CD or just received treatment of 5-ASA -

Exclusion Criteria

1, patients have previous treatment of prednisone, immunosuppressive agents such as azathioprine and biologic agents such as infliximab 2, patients were diagnozed as mild-moderate CD 3, patients have other immune disordered diseases such as SLE, PBC, AIH, PSC, sjogren syndrome, ulcerative colitis, and so on.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CD	colonic tissue biopsy	patients with severe crohn's disease

Primary Outcome Measures

Name	Time	Method
single cell analysis of the colonic tissue of patients with severe crohn's disease	1 year	single cell analysis of the colonic tissue of patients with severe crohn's disease: inflammed and non-inflammed area from right colon or the terminal ileum

Trial Locations

Locations (1)

The First Affiliated Hospital, School of Medicine, Zhejiang University; 🇨🇳 Hanzhou, Zhe Jiang, China