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

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.

Study Overview

• Status: Unknown
• Conditions: Ulcerative Colitis Chronic Moderate; Ulcerative Colitis Chronic Mild
• Intervention / Treatment: Drug: Mesalazine; Device: The Colonic Transendoscopic enteral Tubing.; Drug: Glutamine

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 Type: Interventional
• Enrollment (Anticipated): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210011
      • Recruiting
      • Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Mesalazine conventional enema; Participants undergo the conventional enema of Mesalazine Enemas (4g) for one week.	Drug: Mesalazine; The medications were infused into the colon; Other Names: Mesalazine Enema Product
Experimental: Mesalazine TET enema; Participants undergo the TET enema of Mesalazine Enemas (4g) for one week.	Drug: Mesalazine; The medications were infused into the colon; Other Names: Mesalazine Enema Product; Device: The Colonic Transendoscopic enteral Tubing.; The medications were infused into the colon through the Colonic Transendoscopic enteral Tubing(TET).
Active Comparator: Compound Glutamine conventional enema; Participants undergo the conventional enema of Compound Glutamine (24 tablets of the drug were dissolved in 50ml normal saline) for one week.	Drug: Glutamine; The medications were infused into the colon; Other Names: Glutamine Product
Experimental: Compound Glutamine TET enema; Participants undergo the TET enema of Compound Glutamine (24 tablets of the drug were dissolved in 50ml normal saline) for one week.	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; Other Names: Glutamine Product
Experimental: Compound Glutamine and Mesalazine TET enema; 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.	Drug: Mesalazine; The medications were infused into the colon; Other Names: Mesalazine Enema Product; 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; Other Names: Glutamine Product

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	Number of participants with treatment-related adverse events	10-days

Collaborators and Investigators

• Sponsor: The Second Hospital of Nanjing Medical University

Publications and helpful links

General Publications

• 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.
• 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):288. doi: 10.3390/nu10030288.
• 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 2016 Apr 28.

Study record dates

Study Major Dates

• Study Start (Anticipated): May 15, 2019
• Primary Completion (Anticipated): June 15, 2019
• Study Completion (Anticipated): June 30, 2019

Study Registration Dates

• First Submitted: April 12, 2019
• First Submitted That Met QC Criteria: April 12, 2019
• First Posted (Actual): April 16, 2019

Study Record Updates

• Last Update Posted (Actual): May 15, 2019
• Last Update Submitted That Met QC Criteria: May 14, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: Inflammatory Bowel Disease; Mesalazine; Transendoscopic Enteral Tubing; Compound Glutamine
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer; Colitis; Colitis, Ulcerative; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Mesalamine
• Other Study ID Numbers: TET-CN-190408

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No