Rifaximin in the Treatment of Small Intestinal Bacterial Overgrowth and IBS: Double Blind Randomized Controlled Trial (Multicenter Trial)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 92
- 主要终点
- Global improvement in IBS
研究概览
简要总结
We have recently shown that the majority of patients with irritable bowel syndrome (IBS) have an abnormal lactulose breath test to suggest the presence of bacterial overgrowth of the small intestine. In open label and double blind treatment of IBS subjects with antibiotics, a dramatic improvement in clinical symptoms are observed. In these studies, the antibiotic chosen was neomycin, which is noted to have an efficacy of 20-25% in normalizing the lactulose breath test. A more efficacious antibiotic is needed. Therefore the aim of this study is to determine the efficacy of rifaximin in normalizing the lactulose breath test in IBS subjects with concomitant improvement in clinical symptoms.
详细描述
- Rome I criteria positive IBS subjects will be enrolled in the study after inclusion and exclusion criteria (see below for description of inclusion and exclusion criteria) are applied. There will be no preference given to constipation or diarrhea predominant forms of the condition.
- Subjects will have a 7-day run in phase during which bowel movement consistency and number will be recorded (see Appendix A for bowel movement record).
- At the end of the 7-day run in, subjects will present after a 12 hour fast for a lactulose breath test.
- Prior to breath testing, subjects will be asked to fill out a symptom questionnaire (Appendix B) based on the previous 7 days. Completion of the questionnaire is expected prior to starting the breath test to prevent symptoms from the lactulose interfering with the testing.
- Subjects will then provide a baseline breath sample after which 10g of lactulose will be administered. Breath samples will then be obtained every 15 minutes for 180 minutes. The test will be plotted graphically and sealed by the technician in an envelope. The subject and the investigators will be blinded to the results of the test. See below for details of the breath testing.
- Subjects will then be randomized to receive either placebo or rifaximin (400 mg tid) for 10 days. Compliance will be tested by pill count.
- On completion of the treatment, bowel movement consistency and number will again be recorded for 7 days.
- 7 days after completion of the antibiotic or placebo, subjects will return for a follow up questionnaire (Appendix C) and breath test.
- Subjects will then be sent a weekly questionnaire for a period of 2 months. During the final 7 days of the 2 months, the bowel movement consistency and number will be tracked again.
SPECIFIC METHODS:
Subject selection and enrollment:
Subjects will be selected for all studies based on the Rome I criteria (36). This will be the preferred method of identifying IBS patients to avoid pre-selecting patients with C- IBS. The goal is to evaluate methane as the determinant of transit, not constipation or diarrhea symptoms as through Rome II criteria (37). All subjects who are receiving a prokinetic drug at the time of enrollment will need to have a washout period of 7 days before starting the study protocol. Subjects will be identified through advertising in printed media and through the clinical operations of the GI motility program at Cedars-Sinai Medical Center.
Exclusion Criteria:
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
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
- •Subjects will be selected for all studies based on the Rome I criteria. This will be the preferred method of identifying IBS patients to avoid pre-selecting patients with C- IBS. The goal is to evaluate methane as the determinant of transit, not constipation or diarrhea symptoms as through Rome II criteria. All subjects who are receiving a prokinetic drug at the time of enrollment will need to have a washout period of 7 days before starting the study protocol. Subjects will be identified through advertising in printed media and through the clinical operations of the GI motility program at Cedars-Sinai Medical Center.
排除标准
- •Subjects with a history of inflammatory bowel disease, diabetes, previous intestinal surgery, cirrhosis, celiac disease, probiotic use, current proton pump inhibitor use, recent antibiotic use (past 3 months), history of bowel obstruction, narcotic use or age greater than 65 years will be excluded. Most of these conditions are known to influence enteric bacteria levels. Women of childbearing years will undergo pregnancy testing before participating in the study (See below for details on the pregnancy test used). Women with positive pregnancy tests will be excluded.
结局指标
主要结局
Global improvement in IBS
次要结局
- Improvement in abdominal pain, diarrhea, constipation and bloating