MIcrobiome Analysis of Chronically Constipated Versus Non-constipated Populations for Detection of Novel Molecular Entities With Therapeutic Potential
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 3
- 主要终点
- Identify the presence of microbial substances within stool samples taken from different locations along the colon
研究概览
简要总结
This study intends to evaluate the microbiome of chronically constipated patients as compared to those with a non-constipated gastrointestinal system.
详细描述
Biogeographically accurate microbiome sampling using the HyGIeaCare platform and an evolutionary biology informed learning platform will allow an improved discovery of bacterially derived novel molecular entities with therapeutic potential for chronic constipation. This approach intends to enhance our ability to understand the gut microbiome and use it towards developing therapeutic solutions, in comparison to traditional collection methods and taxonomic-based data analysis approaches.
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 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.
- •For the healthy population - Indication for age-appropriate colorectal cancer screening colonoscopy
- •Adequate capacity to consent to study
- •Patient does not have any known health issues, except for chronic constipation for the "chronic constipation" population.
- •Patient has not taken antibiotics within the last three (3) months.
- •For chronically constipated patients - >3 months of symptomatic constipation with first onset of constipation more than 6 months ago.
- •For chronically constipated patients - Diagnosis of functional constipation by Modified Rome IV Diagnostic Criteria.
排除标准
- •Patient has functional bowel disorders characterized by alternating bowel habits (diarrhea/constipation).
- •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.
- •Current, or recent (within three months) antibiotic usage
- •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
- •GU: Renal insufficiency (CC < 60 ml/min/173m2), cirrhosis with ascites
- •Abdominal surgery within the last 6 months
结局指标
主要结局
Identify the presence of microbial substances within stool samples taken from different locations along the colon
时间窗: 12 months
Finding novel molecular entities with therapeutic potential for chronic constipation using the unique HyGIeaCare approach for constipation relief and collection of fecal material for analysis.
次要结局
未报告次要终点