The Safety and Efficacy of TET Enema in the Treatment of UC

• Status: Unknown status
• Trial end date: 2019-06-30
• Target enrollment: 0
• Participant gender: All

Summary

Colonic Transendoscopic enteral Tubing(TET) is a novel, safe, convenient, and reliable procedure for Fecal Microbiota Transplantation(FMT).This clinical trail aims to evaluate the efficacy and safety of Mesalazine and Compound Glutamine enema in the treatment of Ulcerative Colitis through Colonic TET.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Second Hospital of Nanjing Medical University
• Treatments: Mesalamine

Criteria

Inclusion Criteria:

1. Male or female patients aged between 18 and 65

2. Patients with chronic relapsed mild to moderate active Ulcerative Colitis(left semicolon or extending colonic lesions)

3. Patients who can fully understand this study and voluntarily sign an informed consent;

4. Accept re-examination, follow-up examination and specimen retention in time

5. Suitable for colonoscopy and colonic TET;

6. A history of using Mesalazine and Compound Glutamine safely

Exclusion Criteria:

1. Anti-tumor necrosis factor or methotrexate was used within the first 8 weeks

2. Cyclosporine was used within 4 weeks

3. Antibiotics or probiotics was used within 4 weeks

4. Patients with risk of toxic megacolon, colon cancer or atypical hyperplasia found in pathology

5. History of colon surgery

6. Patients with moderate or severe renal impairment ,abnormal liver function,severe hypertension and cerebrovascular accident

7. Accompanied by other serious diseases, such as cancer or AIDS, that may hinder their enrollment or affect their survival

8. Patients with anxiety, depression, mental or legal disabilities

9. History of suspected or proven alcohol/drug abuse

10. Patients with explosive, massive bloody stools and severe illness who cannot tolerate the colonoscopy

11. Patients who are allergic to salicylic acid or aspirin

12. Patients with food allergies

13. Patients who are preparing to become pregnant during the study period

14. Patients considered by the researchers as unsuitable for enrollment