The Role of Breath Testing in Enriching the Likelihood of Response to Rifaximin in Patients With Diarrhea IBS
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 148
- 试验地点
- 1
- 主要终点
- Number of treatment responders
研究概览
简要总结
The purpose of this study is to learn more about how to improve treatment of patients with diarrhea predominant Irritable Bowel Syndrome (IBS-D) symptoms.Included patients will be requested to answer online surveys and will undergo treatment with rifaximin. Hydrogen breath testing and biologic samples collection will also be completed during the study.
详细描述
The study aims to determine whether hydrogen breath testing can be used to identify patients with IBS-D who are more likely to respond to rifaximin. Participating patients will complete a one week screening period when brief daily survey will be answered. Eligible patients will proceed with the treatment phase of the study, when patients will receive a 14 day course of rifaximin. All included patients will complete glucose and lactulose hydrogen breath tests before and after rifaximin treatment. Biological samples (e.g. blood, stool) will be collected at pre-determined time points and patients will answer daily brief survey for the duration of the study.
It is anticipated that 210 patients will be screened to reach a goal of enrolling 175 patients for the treatment phase of the study.
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
盲法说明
The study drug will be open label. However, the order of the breath tests that are performed (glucose and lactulose) will be blinded to the participant and the person performing the breath sample, and the results of the breath test.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •IBS-D (Rome IV Diagnostic Criteria)
- •Diary compliance for at least 5 days and no rescue medications during baseline
- •Appropriate levels of abdominal pain and diarrhea
排除标准
- •Pregnant women or planning on becoming pregnant while in the study, or lactating women while in the study
- •Inflammatory bowel disease, diabetes mellitus, systemic sclerosis, or celiac disease
- •Active gastrointestinal or hematological malignancy which requires ongoing treatment
- •Surgery to the GI tract in the past 3 months
- •Gastrointestinal infection or diverticulitis in the past 3 months
- •Severe hepatic impairment
- •Any use of antibiotics in the past month
- •Current use of probiotics
- •Any history of allergies to rifaximin or its derivatives
- •Any comitant use of P-glycoprotein inhibitors (for example. Cyclosporine)
- •Known allergies to glucose or lactulose
研究组 & 干预措施
Rifaximin and breath tests
Rifaximin 550mg three times a day for 14 days. Breath tests (glucose and lactulose) will be completed prior to Rifaximin treatment and at week 13 of the study.
干预措施: Rifaximin (Drug)
Rifaximin and breath tests
Rifaximin 550mg three times a day for 14 days. Breath tests (glucose and lactulose) will be completed prior to Rifaximin treatment and at week 13 of the study.
干预措施: Glucose and lactulose hydrogen breath testing (Device)
结局指标
主要结局
Number of treatment responders
时间窗: first 4 weeks after rifaximin treatment
A responder is defined as a patient simultaneously meeting weekly response criteria for abdominal pain (≥30% decrease from baseline in mean weekly pain score) and stool consistency (≥50% decrease from baseline in number of days/week with Bristol Stool Scale type 6 or 7 stool) during ≥2 of the 4 weeks after treatment
次要结局
- Severity of abdominal pain by numeric rating scale (0-10)(baseline (week 1), up to 12 weeks)
- Stool consistency by Bristol Stool Form Scale (1-7)(baseline (week 1), up to 12 weeks)
- Severity of bloating by numeric rating scale (0-10)(baseline (week 1), up to 12 weeks)
- Severity of bowel urgency by rating scale (0-10)(baseline (week 1), up to 12 weeks)
- Compare the predictive value of a pre-treatment glucose vs. lactulose hydrogen breath test for symptomatic response to rifaximin in IBS-D patients.(baseline (week 1), up to 12 weeks)
- Irritable Bowel Syndrome - Quality of Life Measure responder(baseline (week 1), up to 12 weeks)
- Compare the predictive value of a pre-treatment glucose or lactulose hydrogen breath test(first 4 weeks after rifaximin treatment)
研究者
William Chey
Professor of Internal Medicine, Medical School and Professor of Nutritional Sciences, School of Public Health
University of Michigan