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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Ulcerative Colitis Chronic Mild, Ulcerative Colitis Chronic Moderate

Intervention / Treatment
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* Device: The Colonic Transendoscopic enteral Tubing.
* Drug: Glutamine
* Drug: Mesalazine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Inflammatory Bowel Disease, Transendoscopic Enteral Tubing, Mesalazine, Compound Glutamine