NCT06215222招募中不适用
Capsule Microbiota Sampling in IBS/Functional Gastrointestinal Disease
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Collection of 50ul of intestinal fluid from >90% of microbiome sampling capsules
研究概览
简要总结
We will sample intestinal microbiota using a microbiome sampling capsule in Healthy, Irritable Bowel Syndrome (IBS), and Functional Gastrointestinal Disease.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males or females 18 years of age or older and 70 years of age or younger at the time of the first Screening Visit.
- •American Society of Anesthesiologists (ASA) Physical Status Classification System 1 or 2 (1-A normal healthy patient or 2-A patient with mild systemic disease)
- •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 symptoms consistent with SIBO and or IBS and or a Rome Diagnosis of functional GI disorder (Rome IV criteria)
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
- •Active medication use for any gastrointestinal conditions
- •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
结局指标
主要结局
Collection of 50ul of intestinal fluid from >90% of microbiome sampling capsules
时间窗: 1-4 years
Collection of 50ul of intestinal fluid from microbiome sampling capsules
次要结局
- Isolation of liven bacteria from the intestinal fluid of >90% of microbiome sampling capsules(1-4 years)
研究者
Sean Spencer
Instructor
Stanford University
研究点 (1)
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