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

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03917095
• Other study ID #: TET-CN-190408
• Status: Recruiting
• Phase: N/A
• Start date: May 15, 2019
• Est. completion date: June 30, 2019

Study information

• Verified date: May 2019
• Source: The Second Hospital of Nanjing Medical University
• Contact: Faming Zhang, MD,PhD
• Phone: 086-25-58509883
• Email: fzhang[@]njmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Enema is a conventional treatment for Ulcerative Colitis(UC). Mesalazine is suitable for the patients with mild to moderate UC.But for the UC with extending lesions, the conventional anema with Mesalazine or other medicine can not very effective.Colonic Transendoscopic enteral Tubing(TET) is a novel, safe, convenient, and reliable procedure for Fecal Microbiota Transplantation(FMT).Compared with the conventional enema, which is only used for local administration, the Colonic TET enema can achieve total colonic administration.This study aims to evaluate the efficacy and safety of Colonic TET for UC.Patients in this study will be divided into 5 groups according to certain criteria: the Mesalazine conventional enema group, the Mesalazine TET enema group, the Compound Glutamine conventional enema group, the Compound Glutamine TET enema group, the Mesalazine and Compound Glutamine TET enema group.Each group was given enema for 7 days.The primary outcome measure was the clinical remission efficacy rate in each group. The secondary outcome measure was the safety of TET.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis Chronic Mild
• Ulcerative Colitis Chronic Moderate

Intervention

Device:
• The Colonic Transendoscopic enteral Tubing.
The medications were infused into the colon through the Colonic Transendoscopic enteral Tubing(TET).

Drug:
• Glutamine
The medications were infused into the colon
• Mesalazine
The medications were infused into the colon

Locations

Country	Name	City	State
China	Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The Second Hospital of Nanjing Medical University

Country where clinical trial is conducted

China, 

References & Publications (3)

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

Outcome

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