Mesalazine and Compound Glutamin Enema for the Treatment of Ulcerative Colitis Through Colonic Transendoscopic Enteral Tubing: A Multicenter, Randomized, Controlled Trail
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Clinical remission rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Mesalazine conventional enema
Participants undergo the conventional enema of Mesalazine Enemas (4g) for one week.
干预措施: Mesalazine (Drug)
Mesalazine TET enema
Participants undergo the TET enema of Mesalazine Enemas (4g) for one week.
干预措施: The Colonic Transendoscopic enteral Tubing. (Device)
Mesalazine TET enema
Participants undergo the TET enema of Mesalazine Enemas (4g) for one week.
干预措施: Mesalazine (Drug)
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.
干预措施: Glutamine (Drug)
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.
干预措施: The Colonic Transendoscopic enteral Tubing. (Device)
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.
干预措施: Glutamine (Drug)
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.
干预措施: The Colonic Transendoscopic enteral Tubing. (Device)
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.
干预措施: Glutamine (Drug)
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.
干预措施: Mesalazine (Drug)
结局指标
主要结局
Clinical remission rate
时间窗: 10-days
The frequency of defecation and hematochezia score were both zero
The effective rate
时间窗: 10-days
Part of the total Mayo score was 3 points lower than the baseline
次要结局
- Adverse events(10-days)
研究者
Faming Zhang
Professor, Gastroenterology
The Second Hospital of Nanjing Medical University