NCT04254549终止2 期
Evaluating the Therapeutic Efficacy of Rifaximin in Patients With Diabetic Gastroparesis Using Bloating as the Primary Endpoint.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Mayo Clinic
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Improvement in bloating
研究概览
简要总结
Researchers are trying to determine if subjects with diabetic gastroparesis and symptoms of bloating will have a greater improvement in bloating symptoms when treated with rifaximin.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women adult patients, aged 18-75, with diabetic gastroparesis
- •Diagnosis of diabetic gastroparesis will have been made previously using a combination of symptoms (e.g., nausea, vomiting, bloating, early satiety, abdominal pain), the absence of mechanical obstruction, and delayed gastric emptying using a 4-hour, solid phase scintigraphic study (GES; > 20% remaining at 4 hours)
排除标准
- •Prior surgery to the stomach or esophagus
- •Known mechanical obstruction of the GI tract
- •Current or recent (< 4 weeks) use of opioids
- •Current/active use of cannabis
- •Current or recent (< 4 weeks) use of antibiotics
- •Current or recent use of antifungal agents (< 4 weeks)
- •Prior treatment with rifaximin (< 1 year)
- •Uncontrolled diabetes with a HgbA1c > 12
- •Severe uncontrolled or untreated anxiety or depression.
研究组 & 干预措施
Intervention Treatment
Experimental
Subjects diagnosed with gastroparesis will receive Rifaximin
干预措施: Rifaximin (Drug)
Placebo Group
Placebo Comparator
Subjects diagnosed with gastroparesis will receive a placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Improvement in bloating
时间窗: Week 2, week 4, week 8
Change is the self reported bloating questionnaire comprised of 45 questions addressing symptoms of bloating/distention
次要结局
未报告次要终点
研究者
研究点 (2)
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