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

Primary Purpose

Ulcerative Colitis Chronic Mild, Ulcerative Colitis Chronic Moderate

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

The Colonic Transendoscopic enteral Tubing.

Glutamine

Mesalazine

About this trial

This is an interventional other trial for Ulcerative Colitis Chronic Mild focused on measuring Inflammatory Bowel Disease, Transendoscopic Enteral Tubing, Mesalazine, Compound Glutamine

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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
Patients with anxiety, depression, mental or legal disabilities
History of suspected or proven alcohol/drug abuse
Patients with explosive, massive bloody stools and severe illness who cannot tolerate the colonoscopy
Patients who are allergic to salicylic acid or aspirin
Patients with food allergies
Patients who are preparing to become pregnant during the study period
Patients considered by the researchers as unsuitable for enrollment

Sites / Locations

Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Active Comparator

Experimental

Active Comparator

Experimental

Arm Label

Mesalazine conventional enema

Mesalazine TET enema

Compound Glutamine conventional enema

Compound Glutamine TET enema

Compound Glutamine and Mesalazine TET enema

Arm Description

Participants undergo the conventional enema of Mesalazine Enemas (4g) for one week.

Participants undergo the TET enema of Mesalazine Enemas (4g) for one week.

Participants undergo the conventional enema of Compound Glutamine (24 tablets of the drug were dissolved in 50ml normal saline) for one week.

Participants undergo the TET enema of Compound Glutamine (24 tablets of the drug were dissolved in 50ml normal saline) for one week.

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.

Outcomes

Primary Outcome Measures

Clinical remission rate

The frequency of defecation and hematochezia score were both zero

The effective rate

Part of the total Mayo score was 3 points lower than the baseline

Secondary Outcome Measures

Adverse events

Number of participants with treatment-related adverse events

Full Information

NCT ID

NCT03917095

First Posted

April 12, 2019

Last Updated

May 14, 2019

Sponsor

The Second Hospital of Nanjing Medical University

1. Study Identification

Unique Protocol Identification Number

NCT03917095

Brief Title

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

Official Title

Mesalazine and Compound Glutamin Enema for the Treatment of Ulcerative Colitis Through Colonic Transendoscopic Enteral Tubing: A Multicenter, Randomized, Controlled Trail

Study Type

Interventional

2. Study Status

Record Verification Date

May 2019

Overall Recruitment Status

Unknown status

Study Start Date

May 15, 2019 (Anticipated)

Primary Completion Date

June 15, 2019 (Anticipated)

Study Completion Date

June 30, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The Second Hospital of Nanjing Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ulcerative Colitis Chronic Mild, Ulcerative Colitis Chronic Moderate

Keywords

Inflammatory Bowel Disease, Transendoscopic Enteral Tubing, Mesalazine, Compound Glutamine

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Mesalazine conventional enema

Arm Type

Active Comparator

Arm Description

Participants undergo the conventional enema of Mesalazine Enemas (4g) for one week.

Arm Title

Mesalazine TET enema

Arm Type

Experimental

Arm Description

Participants undergo the TET enema of Mesalazine Enemas (4g) for one week.

Arm Title

Compound Glutamine conventional enema

Arm Type

Active Comparator

Arm Description

Participants undergo the conventional enema of Compound Glutamine (24 tablets of the drug were dissolved in 50ml normal saline) for one week.

Arm Title

Compound Glutamine TET enema

Arm Type

Experimental

Arm Description

Participants undergo the TET enema of Compound Glutamine (24 tablets of the drug were dissolved in 50ml normal saline) for one week.

Arm Title

Compound Glutamine and Mesalazine TET enema

Arm Type

Experimental

Arm Description

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.

Intervention Type

Device

Intervention Name(s)

The Colonic Transendoscopic enteral Tubing.

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Glutamine

Other Intervention Name(s)

Glutamine Product

Intervention Description

The medications were infused into the colon

Intervention Type

Drug

Intervention Name(s)

Mesalazine

Other Intervention Name(s)

Mesalazine Enema Product

Intervention Description

The medications were infused into the colon

Primary Outcome Measure Information:

Title

Clinical remission rate

Description

The frequency of defecation and hematochezia score were both zero

Time Frame

10-days

Title

The effective rate

Description

Part of the total Mayo score was 3 points lower than the baseline

Time Frame

10-days

Secondary Outcome Measure Information:

Title

Adverse events

Description

Number of participants with treatment-related adverse events

Time Frame

10-days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 Patients with anxiety, depression, mental or legal disabilities History of suspected or proven alcohol/drug abuse Patients with explosive, massive bloody stools and severe illness who cannot tolerate the colonoscopy Patients who are allergic to salicylic acid or aspirin Patients with food allergies Patients who are preparing to become pregnant during the study period Patients considered by the researchers as unsuitable for enrollment

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Faming Zhang, MD,PhD

Phone

086-25-58509883

fzhang@njmu.edu.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Faming Zhang, MD,PhD

Organizational Affiliation

The Second Hospital of Nanjing Medical University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University

City

Nanjing

State/Province

Jiangsu

ZIP/Postal Code

210011

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Faming Zhang, MD, PhD

Phone

086-25-58509883

fzhang@njmu.edu.cn

12. IPD Sharing Statement

Citations:

PubMed Identifier

26241537

Citation

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.

Results Reference

background

PubMed Identifier

29494494

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):288. doi: 10.3390/nu10030288.

Results Reference

background

PubMed Identifier

27556065

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 2016 Apr 28.

Results Reference

result

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

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