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Evaluation of Stool Microbiome Using HyGIeaCare Prep

NCT ID: NCT04264923

Last Updated: 2020-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-27

Study Completion Date

2020-06-30

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.

Conditions

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Stool Microbiome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

HyGIeaCare Prep

Intervention Type OTHER

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

Interventions

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HyGIeaCare Prep

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

Intervention Type OTHER

Other Intervention Names

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Stool sample evaluation

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

3. Patient had not taken antibiotics within the last 2 months


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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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HyGIeaCare, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David A Johnson, MD

Role: PRINCIPAL_INVESTIGATOR

Eastern Virginia Medical School

Locations

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HyGIeaCare Center

Norfolk, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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HGP-0002

Identifier Type: -

Identifier Source: org_study_id