Evaluation of Stool Microbiome Using HyGIeaCare Prep

HyGIeaCare

Status: Completed

Conditions: Stool Microbiome

Treatments: Other: HyGIeaCare Prep

Study type: Interventional

Funder types: Industry

Identifiers

NCT04264923

HGP-0002

Details and patient eligibility

About

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

Full 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.

Enrollment: 14 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

All patients enrolled

Experimental group

Description:

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

Treatment:

Other: HyGIeaCare Prep