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

NCT ID: NCT03917095

Last Updated: 2019-05-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-15
• Study Completion Date: 2019-06-30

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.

Conditions

Ulcerative Colitis Chronic Mild; Ulcerative Colitis Chronic Moderate

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Mesalazine conventional enema

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

Group Type: ACTIVE_COMPARATOR

Mesalazine

Intervention Type: DRUG

The medications were infused into the colon

Mesalazine TET enema

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

Group Type: EXPERIMENTAL

The Colonic Transendoscopic enteral Tubing.

Intervention Type: DEVICE

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

Mesalazine

Intervention Type: DRUG

The medications were infused into the colon

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.

Group Type: ACTIVE_COMPARATOR

Glutamine

Intervention Type: DRUG

The medications were infused into the colon

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.

Group Type: EXPERIMENTAL

The Colonic Transendoscopic enteral Tubing.

Intervention Type: DEVICE

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

Glutamine

Intervention Type: DRUG

The medications were infused into the colon

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.

Group Type: EXPERIMENTAL

The Colonic Transendoscopic enteral Tubing.

Intervention Type: DEVICE

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

Glutamine

Intervention Type: DRUG

The medications were infused into the colon

Mesalazine

Intervention Type: DRUG

The medications were infused into the colon

Interventions

The Colonic Transendoscopic enteral Tubing.

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

Intervention Type: DEVICE

Glutamine

The medications were infused into the colon

Intervention Type: DRUG

Mesalazine

The medications were infused into the colon

Intervention Type: DRUG

Other Intervention Names

Glutamine Product; Mesalazine Enema Product

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Second Hospital of Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Faming Zhang

Professor, Gastroenterology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Faming Zhang, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

The Second Hospital of Nanjing Medical University

Locations

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

Nanjing, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Faming Zhang, MD,PhD

Role: CONTACT

fzhang@njmu.edu.cn

086-25-58509883

Facility Contacts

Faming Zhang, MD, PhD

Role: primary

fzhang@njmu.edu.cn

086-25-58509883

References

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.

Reference Type: BACKGROUND

PMID: 26241537 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29494494 (View on PubMed)

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.

Reference Type: RESULT

PMID: 27556065 (View on PubMed)

Other Identifiers

TET-CN-190408

Identifier Type: -

Identifier Source: org_study_id