Ulcerative Colitis Chronic Moderate Clinical Trial
Official title:
Mesalazine and Compound Glutamin Enema for the Treatment of Ulcerative Colitis Through Colonic Transendoscopic Enteral Tubing: A Multicenter, Randomized, Controlled Trail
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.
Status | Recruiting |
Enrollment | 75 |
Est. completion date | June 30, 2019 |
Est. primary completion date | June 15, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
China | Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University | Nanjing | Jiangsu |
Lead Sponsor | Collaborator |
---|---|
The Second Hospital of Nanjing Medical University |
China,
Crispino P, Pica R, Unim H, Rivera M, Cassieri C, Zippi M, Paoluzi P. Efficacy of mesalazine or beclomethasone dipropionate enema or their combination in patients with distal active ulcerative colitis. Eur Rev Med Pharmacol Sci. 2015 Aug;19(15):2830-7. — View Citation
Jeong SY, Im YN, Youm JY, Lee HK, Im SY. l-Glutamine Attenuates DSS-Induced Colitis via Induction of MAPK Phosphatase-1. Nutrients. 2018 Mar 1;10(3). pii: E288. doi: 10.3390/nu10030288. — View Citation
Peng Z, Xiang J, He Z, Zhang T, Xu L, Cui B, Li P, Huang G, Ji G, Nie Y, Wu K, Fan D, Zhang F. Colonic transendoscopic enteral tubing: A novel way of transplanting fecal microbiota. Endosc Int Open. 2016 Jun;4(6):E610-3. doi: 10.1055/s-0042-105205. Epub 2 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical remission rate | The frequency of defecation and hematochezia score were both zero | 10-days | |
Primary | The effective rate | Part of the total Mayo score was 3 points lower than the baseline | 10-days | |
Secondary | Adverse events | Number of participants with treatment-related adverse events | 10-days |
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