Effects of Lubiprostone on Small Bowel and Colonic Bacteria: A Correlation Study With Segmental and Whole Gut Transit
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Presence of Small Intestinal Bacterial Overgrowth
研究概览
简要总结
Patients with constipation often have bloating and abdominal distension. It is unclear if this is related to intestinal bacteria. Hypothesis: treatment for constipation may reduce small bowel and colon bacteria colonization, a change in the balance of stool microorganisms, and improve the symptoms of dyspepsia and constipation.
详细描述
This is an open-label study to collect data on upper and lower GI symptoms, hydrogen breath test, stool PCR, and serum before and after 4 weeks of lubiprostone 24 mcg by mouth twice a day for 4 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- 否
入选标准
- •Functional constipation by Rome III criteria
排除标准
- •History of esophageal or gastric surgery (including vagotomy, antireflux, and obesity surgery)
- •History of small bowel or colon resection (excluding appendectomy and cholecystectomy)
- •History of gastric outlet, small bowel, or colon obstruction
- •History of surgery for small bowel adhesion lysis
- •History of surgery for gastroparesis
- •Diagnosis of diabetes requiring daily medications
- •Diagnosis of connective tissue d/o (including scleroderma, lupus, mixed connective tissue disorder)
- •Diagnosis of neuromuscular disorder (including multiple sclerosis, Parkinson, muscular dystrophy, dysautonomia, dystonia)
- •Disorders of small bowel pseudo-obstruction or dumping syndrome
- •Untreated or poorly controlled hypothyroidism
- •Taking an opiate medication daily
- •Taking a medication daily that can cause constipation (calcium channel blocker, anticholinergic, iron supplements, etc.)
- •Active cancer being treated
- •History of significant liver, kidney, cardiac disease that may interfere with study compliance
- •Known allergy or side effects to lubiprostone
- •Non-ambulatory patients: bed-ridden, nursing home resident, etc.
研究组 & 干预措施
Treatment with lubiprostone
Subjects receive lubiprostone and bacteria is measured before and after
干预措施: Lubiprostone (Drug)
结局指标
主要结局
Presence of Small Intestinal Bacterial Overgrowth
时间窗: 28 days
Percent of patients with bacterial overgrowth before and after treatment.
次要结局
- Small Bowel and Colon Transit Time by SmartPill® Transit Study(28 days)
- Small Intestinal Bacterial Overgrowth (SIBO)(28 days)