A Single Center, Randomized, Single-blind Pilot Study to Determine the Safety, Efficacy, and Patient Preference of Split-Dose Regimen of Crystalline Lactulose for Cleansing of the Colon as a Preparation for Colonoscopy in Adults
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Cleanliness of the Colon During Colonoscopy
研究概览
简要总结
The purpose of this study is to determine the efficacy of a split-dose regimen of crystalline lactulose for cleansing of the colon as a preparation for colonoscopy, as assessed by the physician's determination of the cleanliness of the colon using the Boston Bowel Prep Scale (BBPS).
详细描述
This is a single center, open-label, pilot study to determine the safety, efficacy, and patient preference of a split-dose regimen of Crystalline Lactulose for cleansing of the colon prior to colonoscopy. Safety will be assessed by the occurrence of any treatment emergent adverse events. Efficacy will be determined by the endoscopist's rating of the cleanliness of the colon and the incidence of treatment failure (insufficient evacuation of the bowel). Patient preference will be determined by the patient's responses on a patient questionnaire.
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 (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients requiring bowel evacuation for colonoscopy
排除标准
- •Patients with galactosemia (galactose-sensitive diet)
- •Patients known to be hypersensitive to any of the components of Crystalline Lactulose
- •Patients with a history of a failed bowel preparation
- •Patients with severe constipation, defined as those patients taking daily prescription or over-the-counter laxatives
- •Patients with possible bowel obstruction, previous colonic surgery, gastric retention, bowel perforation, toxic colitis, toxic megacolon, or ileus
- •Patients on lactulose therapy or receiving any treatment for chronic constipation
- •Patients less than 18 years of age
- •Inability to understand the requirements of the study or be unwilling to provide written informed consent (as evidenced by signature on an informed consent document approved by an Institutional Review Board [IRB]) and agree to abide by the study restrictions
- •Be pregnant or nursing
- •Be otherwise unsuitable for the study, in the opinion of the Investigator
研究组 & 干预措施
Evening Only (full-dose)
The dosing regimen of Crystalline lactulose will be four 45-gram doses (one dose every 60 minutes for 4 straight hours) taken the evening before the colonoscopy procedure.
干预措施: Crystalline Lactulose (Drug)
Split-dose
The dosing regimen of Crystalline lactulose will be three 45-gram doses (one dose every 60 minutes for 3 straight hours) taken the evening before the colonoscopy procedure followed by one 45-gram dose the morning before the colonoscopy procedure.
干预措施: Crystalline Lactulose (Drug)
结局指标
主要结局
Cleanliness of the Colon During Colonoscopy
时间窗: Day of the procedure
To evaluate the primary objective of efficacy of the split-dose, the following endpoint will be measured: o Physician's determination of the cleanliness of the colon will be evaluated by completion of the Boston bowel prep scale.
次要结局
- Patient Tolerability and Preference(Day before and day of colonoscopy)
- Colonic Hydrogen and Methane Gas Production(Day of colonoscopy)
- Safety/Adverse Events(Day before colonoscopy till 7 days after colonoscopy)
- Treatment Failures(Day of the procedure)