Use of Linaclotide as a Single Agent Colonoscopy Bowel Preparation Regimen; A Pilot Trial
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- BBPS a cutoff 6 or greater
研究概览
简要总结
The goal of this clinical trial is to learn if drug Linaclotide can be used as a single agent regimen to adequately prepare bowel for colonoscopy.
The main question it aims to answer is:
Does drug Linaclotide with Gatorade provide adequate bowel preparation for colonoscopy instead of the standard 4 Liters of Polyethylene glycol (PEG)?
Participants will:
Take one 290mg dose of Linaclotide 36 hours before the procedure and One 290mg dose of Linaclotide 8 hours before the procedure + 2 Liters of Gatorade and a clear liquid diet 24 hours before the procedure. As per standard of care, all patients will be made Nil Per Oral (NPO) starting midnight before the procedure.
The colonoscopy report will then be reviewed for Boston Bowel Preparation Score (BBPS) as a marker of bowel preparation quality, insertion time as a marker of procedure difficulty as well as noted pathology and any complications or physician noted comments.
详细描述
Linaclotide is a novel, FDA approved, intestinal prosecretory agent used to treat chronic constipation and irritable bowel syndrome. Linaclotide reduces colonic transit time and increases luminal fluid secretion. Use of Linaclotide in colonoscopy bowel preparation decreased the volume of oral prep required. We hypothesize that Linaclotide can be used as a single agent regimen to adequately prepare bowel for colonoscopy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
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
- 是
入选标准
- •Adult male and female patients (age 18 years to 65) admitted, who are scheduled for a colonoscopy during their admission.
排除标准
- •Pregnant patients
- •Patients with weight less than 116 pounds
- •Patients with prior colon resection surgeries
- •Presence of colostomy
- •Patients undergoing sigmoidoscopy or pouchoscopy
- •Patients unable to swallow pills/tablets
- •Patients who would use a G or J feeding tubes to administer medications/preparation regimen
- •Patients who are unable to consent for themselves
- •Patients with a history of renal failure
- •Patients already taking Linaclotide
- •Patients who experienced hypersensitivity reactions to Linaclotide in the past
研究组 & 干预措施
Patients scheduled for Colonoscopy
Adult in-patients, 18 years of age and older, scheduled for an in-patient screening or diagnostic colonoscopy
干预措施: Use of Linaclotide as a single agent Colonoscopy prep (Drug)
结局指标
主要结局
BBPS a cutoff 6 or greater
时间窗: Within 48 hours post Colonoscopy
Number of participants with Boston Bowel Preparation Scale (BBPS) of 6 or greater
次要结局
未报告次要终点