Evaluation of Stool Microbiome Using HyGIeaCare Prep

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

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

Study Overview

• Status: Completed
• Conditions: Stool Microbiome
• Intervention / Treatment: Other: HyGIeaCare Prep

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 Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Norfolk, Virginia, United States, 78744
      • HyGIeaCare Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: HyGIeaCare Prep; Each patient will have up to 5 stool specimens for evaluation by a lab for microbial contents.; Other Names: Stool sample evaluation

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: HyGIeaCare, Inc.
• Investigators: Principal Investigator: David A Johnson, MD, Eastern Virginia Medical School

Study record dates

Study Major Dates

• Study Start (Actual): June 27, 2019
• Primary Completion (Actual): December 19, 2019
• Study Completion (Actual): June 30, 2020

Study Registration Dates

• First Submitted: July 24, 2019
• First Submitted That Met QC Criteria: February 7, 2020
• First Posted (Actual): February 11, 2020

Study Record Updates

• Last Update Posted (Actual): July 31, 2020
• Last Update Submitted That Met QC Criteria: July 29, 2020
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: HGP-0002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Initially the data will be used internally.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No