Evaluation of Stool Microbiome Using HyGIeaCare Prep

Not Applicable

Completed

• Conditions: Stool Microbiome
• Interventions: Other: HyGIeaCare Prep

• Registration Number: NCT04264923
• Lead Sponsor: HyGIeaCare, Inc.

Brief Summary

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

Detailed Description

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.

Study Timeline

• Status Verified: 2019-06
• Study Start: 2019-06-27
• Study First Submitted: 2019-07-24
• Primary Completion: 2019-12-19
• Study First Submitted QC: 2020-02-07
• Study First Posted: 2020-02-11
• Study Completion: 2020-06-30
• Last Update Submitted: 2020-07-29
• Last Update Posted: 2020-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

1. Patient's age is between 18 and 80 years old scheduled for elective screening or polyp surveillance indicated colonoscopy
2. Patient does not have any known health issues (as listed in exclusion criteria)
3. Patient had not taken antibiotics within the last 2 months

Exclusion Criteria

1. Patient has functional bowel disorders characterized by alternating bowel habits (diarrhea/constipation), chronic diarrhea or chronic constipation (requiring pharmacologic prescription treatment)

2. Patient has secondary constipation (colonic obstruction, medications, metabolic cause)

3. 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

4. Patient has any of the contraindications listed below:

   1. Cardiac: Congestive heart failure (NYHA class III or IV or EF <50%)
   2. 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)
   3. GU: Renal insufficiency (CC < 60 ml/min/173m2), cirrhosis with ascites
   4. Abdominal surgery within the last 6 months
   5. Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All patients enrolled	HyGIeaCare Prep	All patients enrolled with receive the HyGIeaCare Prep with a new lab sampling technique to be used on all patients enrolled in the study.

Primary Outcome Measures

Name	Time	Method
Microbial classification	6 months	The number of genes present will be counted
Diversity between stool and colon effluent samples	6 months	Alpha diversity by Shannon diversity index, presence and number of taxa to be documented
Inner diversity of samples	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	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

HyGIeaCare Center; 🇺🇸 Norfolk, Virginia, United States