NCT06298409招募中1 期
Evaluating the Effect of Rifaximin on the Regional Composition of the Gut Microbiota and Metabolic Profiles of Subjects With SIBO Using the CapScan® Collection Capsule
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Sampling of gut microbiota
研究概览
简要总结
We will sample intestinal microbiota using a microbiome sampling capsule in patients with Small Intestinal Bacterial Overgrowth (SIBO)
详细描述
Prospective, open-label, single-arm, non-randomized, multi-center study designed to evaluate the effect of the antibiotic rifaximin on the regional composition of the gut microbiota and metabolic profiles of subjects diagnosed with SIBO, using the CapScan collection capsule.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
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
- •Males or females 18 years of age or older and 80 years of age or younger at the time of the first Screening Visit.
- •ASA Classification 1 or
- •For women of childbearing potential, negative urine pregnancy test within 7 days of Screening Visit.
- •Willingness to use highly effective contraception during the entire study period (e.g.: implants, injectables, oral contraceptives, intra-uterine device or declared abstinence).
- •Subject is fluent in English and understands the study protocol and informed consent and is willing and able to comply with study requirements and sign the informed consent form.
- •Positive for at least one clinical symptom consistent with SIBO.
- •Positive lactulose breath test for SIBO, by Hydrogen (H2) criteria.
- •Prescribed, but has not started, a two-week course of Rifaximin for SIBO.
排除标准
- •History of any of the following: Prior gastric or esophageal surgery, including lap banding or bariatric surgery, bowel obstruction, gastric outlet obstruction, diverticulitis, inflammatory bowel disease, ileostomy or colostomy, gastric or esophageal cancer, achalasia, esophageal diverticulum, active dysphagia or odynophagia.
- •Actively taking a proton-pump-inhibitor medication within 30 days of enrollment
- •Pregnancy or planned pregnancy within 30 days from Screening Visit, or breast-feeding
- •Any form of active substance abuse or dependence (including drug or alcohol abuse), unstable medical or psychiatric disorder, or any chronic condition susceptible, in the opinion of the investigator, to interfere with the conduct of the study
- •A clinical condition that, in the judgment of the investigator, could potentially pose a health risk to the subject while involved in the study
结局指标
主要结局
Sampling of gut microbiota
时间窗: 56 days
\> 75% of the retrieved CapScan devices to provide at least 3 million metagenomic DNA sequencing reads of gut microbes from the intestinal tract, and at least 900 annotated gut metabolites.
Sampling of gut metabolome
时间窗: 56 days
\>75% of the retrieved CapScan devices to provide at least 900 annotated gut metabolites.
次要结局
- Effect of rifaximin on gut microbiota(56 days)
- Effect of rifaximin on gut metabolome(56 days)
研究者
研究点 (2)
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