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

Not Applicable

• Conditions: Ulcerative Colitis Chronic Mild; Ulcerative Colitis Chronic Moderate
• Interventions: Device: The Colonic Transendoscopic enteral Tubing.; Drug: Mesalazine; Drug: Glutamine

• Registration Number: NCT03917095
• Lead Sponsor: The Second Hospital of Nanjing Medical University

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2019-04-12
• Study First Submitted QC: 2019-04-12
• Study First Posted: 2019-04-16
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-14
• Study Start: 2019-05-15
• Last Update Posted: 2019-05-15
• Primary Completion: 2019-06-15
• Study Completion: 2019-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 75

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mesalazine TET enema	The Colonic Transendoscopic enteral Tubing.	Participants undergo the TET enema of Mesalazine Enemas (4g) for one week.
Compound Glutamine TET enema	The Colonic Transendoscopic enteral Tubing.	Participants undergo the TET enema of Compound Glutamine (24 tablets of the drug were dissolved in 50ml normal saline) for one week.
Compound Glutamine TET enema	Glutamine	Participants undergo the TET enema of Compound Glutamine (24 tablets of the drug were dissolved in 50ml normal saline) for one week.
Compound Glutamine and Mesalazine TET enema	The Colonic Transendoscopic enteral Tubing.	Participants undergo the TET enema of Mesalazine(4g) and Compound Glutamine (24 tablets of the drug were dissolved in 50ml normal saline) for one week.
Compound Glutamine and Mesalazine TET enema	Glutamine	Participants undergo the TET enema of Mesalazine(4g) and Compound Glutamine (24 tablets of the drug were dissolved in 50ml normal saline) for one week.
Mesalazine conventional enema	Mesalazine	Participants undergo the conventional enema of Mesalazine Enemas (4g) for one week.
Mesalazine TET enema	Mesalazine	Participants undergo the TET enema of Mesalazine Enemas (4g) for one week.
Compound Glutamine conventional enema	Glutamine	Participants undergo the conventional enema of Compound Glutamine (24 tablets of the drug were dissolved in 50ml normal saline) for one week.
Compound Glutamine and Mesalazine TET enema	Mesalazine	Participants undergo the TET enema of Mesalazine(4g) and Compound Glutamine (24 tablets of the drug were dissolved in 50ml normal saline) for one week.

Primary Outcome Measures

Name	Time	Method
Clinical remission rate	10-days	The frequency of defecation and hematochezia score were both zero
The effective rate	10-days	Part of the total Mayo score was 3 points lower than the baseline

Secondary Outcome Measures

Name	Time	Method
Adverse events	10-days	Number of participants with treatment-related adverse events

Trial Locations

Locations (1)

Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University; 🇨🇳 Nanjing, Jiangsu, China