Evaluation of Stool Microbiome Using HyGIeaCare Prep

Stool Microbiome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04264923
• Other study ID #: HGP-0002
• Status: Completed
• Phase: N/A
• Start date: June 27, 2019
• Est. completion date: June 30, 2020

Study information

• Verified date: June 2019
• Source: HyGIeaCare, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: June 30, 2020
• Est. primary completion date: December 19, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Stool Microbiome

Intervention

Other:
• HyGIeaCare Prep
Each patient will have up to 5 stool specimens for evaluation by a lab for microbial contents.

Locations

Country	Name	City	State
United States	HyGIeaCare Center	Norfolk	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
HyGIeaCare, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Microbial classification	The number of genes present will be counted	6 months
Primary	Diversity between stool and colon effluent samples	Alpha diversity by Shannon diversity index, presence and number of taxa to be documented	6 months
Primary	Inner diversity of samples	ANOVA test will be used to acknowledge differences between samples, presence and number of taxa to be documented	6 months
Primary	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	Functional genes analysis	The presence of genes known to represent biochemical functions will be counted and documented	6 months
Secondary	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