Double-blind, Placebo Controlled Trial Comparing Neomycin to Rifaximin Plus Neomycin in the Treatment of Methane Positive Subjects With Constipation-predominant Irritable Bowel Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 37
- 试验地点
- 2
- 主要终点
- Severity of Constipation in Each Arm at Week 1 After Completion of Therapy
研究概览
简要总结
In this study the investigators aim to compare the efficacy of neomycin to a combination of rifaximin and neomycin in the treatment of C-IBS subjects with methane on their breath test. This study will be conducted in collaboration with Dr. John DiBaise at the Mayo Clinic in Scottsdale, AZ and Dr. Satish Rao in Georgia Regents University in Augusta, GA.
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
- Triple (Participant, Care Provider, 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
- •Rome III positive IBS subjects (18-75 years of age)
- •Meet criteria for constipation predominant IBS symptoms including ≤ 3 complete spontaneous bowel movements per week with hard or lumpy stools.
- •Presence of detectable methane on single breath sample (≥ 3ppm).
- •If subjects are ≥ 50 years old, a colonoscopy had to have been completed within the past 5 years.
排除标准
- •Subjects with history of intestinal surgery (except appendectomy or cholecystectomy)
- •Recent antibiotic use (within the last 30 days)
- •Subjects with known pelvic floor dysfunction
- •Pregnancy
- •Creatinine level > 1.4
- •Poorly controlled/uncontrolled significant medical condition that would interfere with study procedures
- •Subjects with hearing loss and/or tinnitus
- •History of bowel obstruction
- •History of celiac disease
- •History of inflammatory bowel disease
- •Cirrhosis
研究组 & 干预措施
Group 1
Group 1 will receive neomycin (500 mg po bid) and placebo (tid) for 14 days
干预措施: Neomycin (Drug)
Group 1
Group 1 will receive neomycin (500 mg po bid) and placebo (tid) for 14 days
干预措施: Placebo (Drug)
Group 2
Group 2 will receive neomycin (500 mg po bid) and rifaximin (550mg po tid) for 14 days
干预措施: Neomycin (Drug)
Group 2
Group 2 will receive neomycin (500 mg po bid) and rifaximin (550mg po tid) for 14 days
干预措施: Rifaximin (Drug)
结局指标
主要结局
Severity of Constipation in Each Arm at Week 1 After Completion of Therapy
时间窗: 1 year
Visual analog scale (VAS) score for constipation: Severity was rated using a VAS from 0 to 100 units (with 0 = no symptom and 100 = severe symptoms).
次要结局
- Change in Methane From Baseline(Baseline (Day 0) and Final Visit (Day 44))
研究者
Mark Pimentel, MD
Director, GI Motility Program
Cedars-Sinai Medical Center