Evaluation of Stool Microbiome Using HyGIeaCare Prep

Study Overview
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Brief Summary
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Stool samples will be collected before and during the HyGIeaCare procedure and the samples will be sent for microbiome evaluation.

Detailed Description
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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.

Official Title
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Pilot Study: Quality Evaluation of Stool Samples Collected for Microbiome Analysis Using the HyGIeaCare Prep

Conditions
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Stool Microbiome

Intervention / Treatment
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* Other: HyGIeaCare Prep


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 exclusion criteria) 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 Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Interventional Model Description: Patients between 18 and 80 years old who do not have any known health issues and who have not taken antibiotics within the last two months.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: All patients enrolled<br>All patients enrolled with receive the HyGIeaCare Prep with a new lab sampling technique to be used on all patients enrolled in the study. | Other: HyGIeaCare Prep<br>* Each patient will have up to 5 stool specimens for evaluation by a lab for microbial contents.<br>* Other names: Stool sample evaluation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microbial classification | The number of genes present will be counted | 6 months | 
| Diversity between stool and colon effluent samples | Alpha diversity by Shannon diversity index, presence and number of taxa to be documented | 6 months | 
| Inner diversity of samples | ANOVA test will be used to acknowledge differences between samples, presence and number of taxa to be documented | 6 months | 
| Contribution of the variables to samples' diversity | 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 | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional genes analysis | The presence of genes known to represent biochemical functions will be counted and documented | 6 months | 
| Biosynthetic gene clusters | Groups of genes with known biosynthetic functions and found to be clustered will be counted and documented together in the different samples | 6 months |