Validation of the Small Intestine Microbiome Aspiration (SIMBA) Capsule
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Bacterial composition
研究概览
简要总结
Prospective, open label trial to establish the ability of the SIMBA Capsule to accurately obtain a sample from the small bowel of participants with IBS (10 constipation-predominant (IBS-C) and 10 diarrhea-predominant (IBS-D)) and healthy participants (n=10). The accuracy of targeting the small bowel will be established by visual confirmation via X-ray. The clinical utility of the collected sample will be evaluated by analysis with samples obtained by the current gold standard (duodenal aspirate), as well as stool analysis and LBT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Aged between 18 and 70 years.
- •Diagnosis of IBS by Rome 4 criteria (IBS groups) or no previous diagnosis of IBS or suspected IBS (Control group).
- •Ability to understand and provide informed consent.
- •Ability and willingness to meet the required schedule and study interventions.
- •No planned change in diet or medical interventions during the study duration.
- •Adequate mobility to transfer repeatedly between X-ray (standing or lying), and waiting (sitting).
- •Willing and able to undergo a sedated esophagogastroduodenoscopy (EGD) with aspirate and brushing.
排除标准
- •Prior gastrointestinal disease, surgery, or radiation treatment which, in the investigator's opinion, would lead to intestinal structuring or obstruction with a risk of capsule non-excretion (particular diseases which would be assessed on a case-by-case basis would include, achalasia, eosinophilic esophagitis, Crohn's disease, cancer diagnosis or treatment within the past year, or previous esophageal, gastric, small intestinal, or colonic surgery. Appendectomy or cholecystectomy more than 3 months prior to enrollment are acceptable).
- •Use of any medications in the previous week that could substantially alter gastrointestinal motor function (e.g., opioids, prokinetics, anticholinergics, laxatives), or acidity (PPI, H2RA).
- •History of oropharyngeal dysphagia or other swallowing disorder with a risk of aspiration of the capsule.
- •Females of childbearing age who are not practicing birth control and/or are pregnant or lactating.
- •No antibiotics, or colon cleanses/bowel prep for 2 weeks.
- •< 2 bowel movements per week (Control Group).
研究组 & 干预措施
IBS-D
Participant diagnosed with Irritable Bowel Syndrome, diarrhea predominant, confirmed by study doctors using Rome IV criteria.
干预措施: Ingestible capsule (Device)
IBS-D
Participant diagnosed with Irritable Bowel Syndrome, diarrhea predominant, confirmed by study doctors using Rome IV criteria.
干预措施: Sedated EGD (Procedure)
IBS-D
Participant diagnosed with Irritable Bowel Syndrome, diarrhea predominant, confirmed by study doctors using Rome IV criteria.
干预措施: Lactulose Breath Test (Diagnostic Test)
IBS-C
Participant diagnosed with Irritable Bowel Syndrome, constipation predominant, confirmed by study doctors using Rome IV criteria.
干预措施: Ingestible capsule (Device)
IBS-C
Participant diagnosed with Irritable Bowel Syndrome, constipation predominant, confirmed by study doctors using Rome IV criteria.
干预措施: Sedated EGD (Procedure)
IBS-C
Participant diagnosed with Irritable Bowel Syndrome, constipation predominant, confirmed by study doctors using Rome IV criteria.
干预措施: Lactulose Breath Test (Diagnostic Test)
Healthy Control
Participant with no ongoing medical conditions affecting GI health.
干预措施: Ingestible capsule (Device)
Healthy Control
Participant with no ongoing medical conditions affecting GI health.
干预措施: Sedated EGD (Procedure)
Healthy Control
Participant with no ongoing medical conditions affecting GI health.
干预措施: Lactulose Breath Test (Diagnostic Test)
结局指标
主要结局
Bacterial composition
时间窗: same day
1. Correlations of bacterial composition (superimposability of PLS-DA mapping) of samples collected by the SIMBA Capsule compared to small bowel aspirate and to mucosal microbiome sample obtained by brushing. (hypothesis: findings will be similar)
次要结局
- Bacterial composition(within 5 days of primary measures)