Evaluate Lactulose for Bowel Preparation in Patients With Inflammatory Bowel Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- effective preparation rate
研究概览
简要总结
The goal of this clinical trial is to evaluate the efficacy, safety and tolerability of lactulose in bowel preparation in IBD patients. The main question it aims to answer is: Does lactulose have better efficacy, safety and tolerability than 3L-PEG? Participants will be divided into PEG group or Lactulose group at a 1:1 ratio by a random number method. Each patient will get a leaflet provided by hospital introducing bowel preparation methods and diet restriction before bowel preparation. They will have bowel preparation with different drugs according to group. The grade of bowel cleansing will be assessed through the Boston Bowel Preparation Scale (BBPS). The tolerability, satisfaction and safety of the two bowel preparation methods will be assessed through the patients self-administered questionnaires.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients with confirmed IBD or suspected IBD for at least 3 months, aged between 16-75 years and requiring a colonoscopy are invited to participate in our study. The diagnosis of IBD is based on recognized standards, including clinical symptoms, endoscopy, radiology, pathology and surgical history.
排除标准
- •Patients are excluded if they (1) are clinical active UC and CD, (2) are known or suspected gastrointestinal obstruction, bowel perforation, toxic colitis or megacolon, recent or active gastrointestinal bleeding, (3) are congestive heart failure, severe renal failure, (4) are severe dehydration or electrolyte disturbances, (5) are pregnant, (6) are allergic to PEG or Lactulose, (7) are diabetics, (8) are lactose or galactose intolerance, (9) refuse to participate in this study.
研究组 & 干预措施
Patients take Lactulose for bowel preparation
Patients take Lactulose for bowel preparation.
干预措施: 3 bottles of Lactulose oral solution (Drug)
Patients take 3L-polyethylene glycol for bowel preparation
Patients take 3L-polyethylene glycol for bowel preparation
.
干预措施: 3L-polyethylene glycol (Drug)
结局指标
主要结局
effective preparation rate
时间窗: 5 minutes before the colonoscopy ends
Boston Bowel Preparation Scale (BBPS) \>= 6 with a partial score \>= 2 in each colon segment
incidence of adverse events
时间窗: 2 hours after having bowel preparation
incidence of adverse events in each group
taste score evaluated by patients
时间窗: 2 hours after having bowel preparation
Five-point scale is used to evaluate taste (very bad, bad, moderate, good, very good)
次要结局
- effects of bowel preparation drugs on liver function(2 hours after having bowel preparation)
- effects of bowel preparation drugs on serum electrolyte(2 hours after having bowel preparation)