Pilot Study: Quality Evaluation of Stool Samples Collected for Microbiome Analysis Using the HyGIeaCare Prep
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Microbial classification
研究概览
简要总结
Stool samples will be collected before and during the HyGIeaCare procedure and the samples will be sent for microbiome evaluation.
详细描述
Patients will have the HyGIeaCare procedure as originally prescribed by their physician. Before and during the procedure stool samples will be collected and sent to a lab for microbiome evaluation.
It is anticipated that stool samples collected from the HyGIeaCare prep will provide more microbiological and biochemical information on the gut interior than using traditional stool samples.
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
- 是
入选标准
- •Patient's age is between 18 and 80 years old scheduled for elective screening or polyp surveillance indicated colonoscopy
- •Patient does not have any known health issues (as listed in
排除标准
- •Patient had not taken antibiotics within the last 2 months
- •Exclusion Criteria:
- •Patient has functional bowel disorders characterized by alternating bowel habits (diarrhea/constipation), chronic diarrhea or chronic constipation (requiring pharmacologic prescription treatment)
- •Patient has secondary constipation (colonic obstruction, medications, metabolic cause)
- •Patient has any other condition that, in the opinion of the investigator, may adversely affect the compliance or safety of the patient or would limit the patient's ability to complete the study
- •Patient has any of the contraindications listed below:
- •Cardiac: Congestive heart failure (NYHA class III or IV or EF <50%)
- •GI: Intestinal perforation, carcinoma of the rectum, fissures or fistula, severe hemorrhoids, abdominal hernia, recent colon or rectal surgery, or abdominal surgery, inflammatory bowel disease. History of gastrointestinal surgery- (small bowel, colon. Bariatric surgery)
- •GU: Renal insufficiency (CC < 60 ml/min/173m2), cirrhosis with ascites
- •Abdominal surgery within the last 6 months
研究组 & 干预措施
All patients enrolled
All patients enrolled with receive the HyGIeaCare Prep with a new lab sampling technique to be used on all patients enrolled in the study.
干预措施: HyGIeaCare Prep (Other)
结局指标
主要结局
Microbial classification
时间窗: 6 months
The number of genes present will be counted
Diversity between stool and colon effluent samples
时间窗: 6 months
Alpha diversity by Shannon diversity index, presence and number of taxa to be documented
Inner diversity of samples
时间窗: 6 months
ANOVA test will be used to acknowledge differences between samples, presence and number of taxa to be documented
Contribution of the variables to samples' diversity
时间窗: 6 months
Principal component analysis (PCoA) will be used to mark significant differences between the samples, taxa will be identified by presence, percentage of sample will be documented
次要结局
- Functional genes analysis(6 months)
- Biosynthetic gene clusters(6 months)