The Safety and Efficacy of TET Enema in the Treatment of UC (NCT03917095) | Clinical Trial Compass
UnknownNot Applicable
The Safety and Efficacy of TET Enema in the Treatment of UC
China75 participantsStarted 2019-05-15
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Male or female patients aged between 18 and 65
✓. Patients with chronic relapsed mild to moderate active Ulcerative Colitis(left semicolon or extending colonic lesions)
✓. Patients who can fully understand this study and voluntarily sign an informed consent;
✓. Accept re-examination, follow-up examination and specimen retention in time
✓. Suitable for colonoscopy and colonic TET;
✓. A history of using Mesalazine and Compound Glutamine safely
Exclusion criteria
✕. Anti-tumor necrosis factor or methotrexate was used within the first 8 weeks
✕. Cyclosporine was used within 4 weeks
✕. Antibiotics or probiotics was used within 4 weeks
✕. Patients with risk of toxic megacolon, colon cancer or atypical hyperplasia found in pathology
✕. History of colon surgery
✕. Patients with moderate or severe renal impairment ,abnormal liver function,severe hypertension and cerebrovascular accident
✕. Accompanied by other serious diseases, such as cancer or AIDS, that may hinder their enrollment or affect their survival
What they're measuring
1
Clinical remission rate
Timeframe: 10-days
2
The effective rate
Timeframe: 10-days
Trial details
NCT IDNCT03917095
SponsorThe Second Hospital of Nanjing Medical University