Evaluation of Stool Microbiome Using HyGIeaCare Prep

NCT04264923 | Completed

• 1 other identifier: HGP-0002
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Stool Microbiome

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Functional genes analysis

  6 months

• Biosynthetic gene clusters

  6 months

Study Arms (1)

All patients enrolled

EXPERIMENTAL

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

Interventions

HyGIeaCare Prep OTHER

Each patient will have up to 5 stool specimens for evaluation by a lab for microbial contents.

Also known as: Stool sample evaluation

All patients enrolled

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient's age is between 18 and 80 years old scheduled for elective screening or polyp surveillance indicated colonoscopy

You may not qualify if:

• Patient had not taken antibiotics within the last 2 months
• 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

Sponsors & Collaborators

• HyGIeaCare, Inc.: lead

Study Sites (1)

HyGIeaCare Center

Norfolk, Virginia, 78744, United States

Location

Study Officials

• David A Johnson, MD

  Eastern Virginia Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 24, 2019
• First Posted: February 11, 2020
• Study Start: June 27, 2019
• Primary Completion: December 19, 2019
• Study Completion: June 30, 2020
• Last Updated: July 31, 2020

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)