NCT04489329已完成不适用
Use of the Small Intestine Microbiome Aspiration (SIMBA) Capsule to Detect a Dietary Intervention in the Small Intestine
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Bacterial density count
研究概览
简要总结
Proof of concept study to validate the ability of a capsule device to gather samples from the small bowel for microbiome analysis in adults and to detect dietary changes from simultaneous ingestion of a probiotic.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 to 65 years old
- •On no medication, or on stable doses of medications which will not be changed over the course of the study
- •Willingness to maintain their usual dietary habits and physical activity
- •Willing to discontinue consumption of fermented foods or probiotics (such as kombucha, yogurts with live, active cultures, or probiotic supplements) for the duration of the study.
- •Ability to understand and provide informed consent
- •Ability and willingness to meet the required schedule and study tasks and interventions
- •Willing to fast for at least 8 hours before the 2 intake visits (Visit 1 and Visit 2)
排除标准
- •History of a small intestine obstruction of symptoms of an intermittent small intestine obstruction (i.e., recurrent abdominal pain, distention, nausea and vomiting).
- •Pregnant or breastfeeding or planning on becoming pregnant during study timeline.
- •Use of other investigational product within 3 months of start of the study.
- •Suffering from immune disorders or with possible immune deficient status
- •Allergy to soy or milk.
- •Prior gastrointestinal surgery which has altered the anatomy of the esophagus, stomach or small or large intestine (exceptions include appendectomy or cholecystectomy more than 3 months prior to enrollment).
- •Use of any medications in the previous 7 days that could substantially alter gastrointestinal motor function (e.g. opioids, prokinetics, anticholinergics, laxatives), acidity (PPI, H2RA), or integrity (NSAIDs, oral steroids).
- •Body Mass Index (BMI) >
- •Previous history of gastric bezoar or gastroparesis.
- •Any abdominal or pelvic surgery within the past 3 months.
- •Known history of inflammatory bowel disease and/or Crohn's disease.
- •History of diverticulitis, diverticular stricture, or other intestinal strictures.
- •History of abdominal or pelvic radiotherapy.
- •History of dysphagia, eosinophilic esophagitis, esophageal stricture, or other swallowing disorder.
- •Cardiovascular, endocrine, renal or other chronic disease likely to affect motility.
- •Colon cleansing prep for 1 month before the first visit, or during the study.
- •Use of antibiotics, prebiotics, herbal supplements, or probiotics for 2 weeks before the first visit, or during the study.
- •< 2 bowel movements per week.
结局指标
主要结局
Bacterial density count
时间窗: 7 days
density count of probiotic strain compared between capsule and stool sample (CFU/ml)
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
To Evaluate the Feasibility of Collecting Duodenal Fluid With SIMBA CapsulesLiver CirrhosisNCT06708832Vanessa Stadlbauer-Koellner, MD11
招募中
不适用
Evaluation of the SIMBA Capsule for Small Intestinal DysbiosisFunctional DyspepsiaCrohn DiseaseCeliac DiseaseIrritable Bowel SyndromeType 2 DiabetesUlcerative ColitisNCT05633706Nimble Science Ltd.300
已完成
不适用
Validation of the Small Intestine Microbiome Aspiration (SIMBA) CapsuleProof of ConceptIrritable Bowel SyndromeNCT04094558University of Calgary30
招募中
不适用
Capillary Endoscopy Aspiration CatheterMicrobiotaSIBONCT04418258Cedars-Sinai Medical Center46
终止
不适用
Evaluation of the Microbiome in Multiple SclerosisMultiple SclerosisNCT05844826Nimble Science Ltd.40