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
1 other identifier
interventional
75
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 12, 2019
CompletedFirst Posted
Study publicly available on registry
April 16, 2019
CompletedStudy Start
First participant enrolled
May 15, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 15, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2019
CompletedMay 15, 2019
May 1, 2019
1 month
April 12, 2019
May 14, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (1)
Adverse events
10-days
Study Arms (5)
Mesalazine conventional enema
ACTIVE COMPARATORParticipants undergo the conventional enema of Mesalazine Enemas (4g) for one week.
Mesalazine TET enema
EXPERIMENTALParticipants undergo the TET enema of Mesalazine Enemas (4g) for one week.
Compound Glutamine conventional enema
ACTIVE COMPARATORParticipants undergo the conventional enema of Compound Glutamine (24 tablets of the drug were dissolved in 50ml normal saline) for one week.
Compound Glutamine TET enema
EXPERIMENTALParticipants 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
EXPERIMENTALParticipants undergo the TET enema of Mesalazine(4g) and Compound Glutamine (24 tablets of the drug were dissolved in 50ml normal saline) for one week.
Interventions
The medications were infused into the colon through the Colonic Transendoscopic enteral Tubing(TET).
The medications were infused into the colon
The medications were infused into the colon
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210011, China
Related 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.
PMID: 26241537BACKGROUNDJeong 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.
PMID: 29494494BACKGROUNDPeng 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.
PMID: 27556065RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Faming Zhang, MD,PhD
The Second Hospital of Nanjing Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, Gastroenterology
Study Record Dates
First Submitted
April 12, 2019
First Posted
April 16, 2019
Study Start
May 15, 2019
Primary Completion
June 15, 2019
Study Completion
June 30, 2019
Last Updated
May 15, 2019
Record last verified: 2019-05