Severe Crohn's Diease Clinical Trial
Official title:
Evaluating the Immune Status of Patients With Severe Crohn's Disease Using Single Cell Sequencing
| NCT number | NCT04135482 |
| Other study ID # | ZJU-JX-CD1 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | October 21, 2019 |
| Est. completion date | July 31, 2020 |
| Verified date | October 2019 |
| Source | First Affiliated Hospital of Zhejiang University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
Using single cell sequencing method to evaluate and compare the immune status of patients with severe CD.
| Status | Completed |
| Enrollment | 10 |
| Est. completion date | July 31, 2020 |
| Est. primary completion date | July 15, 2020 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 80 Years |
| Eligibility | 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. - |
| Country | Name | City | State |
|---|---|---|---|
| China | The First Affiliated Hospital, School of Medicine, Zhejiang University | Hanzhou | Zhe Jiang |
| Lead Sponsor | Collaborator |
|---|---|
| First Affiliated Hospital of Zhejiang University |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | single cell analysis of the colonic tissue of patients with severe crohn's disease | 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 | 1 year |