A New Dimension in Modeling Irritable Bowel Syndrome (IBS) to Elucidate Novel Diagnostic Biomarkers and Microbiome Signatures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Serotonin level
研究概览
简要总结
Microbiota from fecal samples from IBS-D patients, in combination with vitamin D supplementation added to our 3-D immunocompetent intestinal models will establish a high fidelity disease model to achieve our long-term goal to understand the relationship between gut microbiome, vitamin D levels, host gene expression and IBS-D symptoms that could ultimately be used as a testing platform for treatment and prevention.
详细描述
The pathophysiology of IBS is not well understood. Preliminary studies support IBS-D patients with varied microbiome fingerprints, vitamin D levels, and blood serotonin levels compared to non-IBS patients. The investigators have novel 3-D immunocompetent intestinal models to establish a new model of high fidelity disease to examine the relationship of IBS-D patients gut microbiome, with supplemental vitamin D levels, and the relationship of blood serotonin and vitamin D levels. IBS-D patients and healthy controls will be asked to provide a fecal sample, a biopsy sample of colonic tissue obtained during a clinically appropriate flexible sigmoidoscopy or colonoscopy, and a blood sample. There will be 1-2 office visits. One visit will last 30 minutes, the second visit no longer than 3 hours. This study is funded by a combined MAYO-Arizona State University seed grant. The samples will be analyzed at ASU. Our long-term goal is to understand the relationship between gut microbiome, vitamin D levels, host gene expression, serotonin levels, and IBS-D symptoms that could ultimately be used as a testing platform for treatment and prevention of this highly prevalent disorder.
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
- 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
- •IBS-D subjects:
- •Patients who fulfill IBS-D criteria, without causes of active inflammation.
- •active symptoms for at least 2 months
- •diagnosed at least 6 months prior to enrollment
- •Healthy Control:
- •Healthy control patients should have no active infection or inflammation.
排除标准
- •does not meet inclusion criteria
- •will not participate in blood draw, stool sample donation, or endoscopy
- •history of acute illness within 3 months of testing
- •any fecal transplant history
研究组 & 干预措施
IBS-D patients
Subjects on this arm will have an endoscopy for tissue biopsy, and provide blood samples and stool samples.
干预措施: endoscopy for tissue biopsy (Procedure)
IBS-D patients
Subjects on this arm will have an endoscopy for tissue biopsy, and provide blood samples and stool samples.
干预措施: Blood Sample (Other)
IBS-D patients
Subjects on this arm will have an endoscopy for tissue biopsy, and provide blood samples and stool samples.
干预措施: Stool Sample (Other)
Healthy Controls
Subjects on this arm will have an endoscopy for tissue biopsy, and provide blood samples and stool samples.
干预措施: endoscopy for tissue biopsy (Procedure)
Healthy Controls
Subjects on this arm will have an endoscopy for tissue biopsy, and provide blood samples and stool samples.
干预措施: Blood Sample (Other)
Healthy Controls
Subjects on this arm will have an endoscopy for tissue biopsy, and provide blood samples and stool samples.
干预措施: Stool Sample (Other)
结局指标
主要结局
Serotonin level
时间窗: Study Day 2
2 blood vials will be drawn during the flexible sigmoidoscopy or colonoscopy procedure, and serotonin levels will be drawn from one of these blood samples.
次要结局
未报告次要终点
