Clinical trial NCT04264923: Evaluation of Stool Microbiome Using HyGIeaCare Prep
Official title: Pilot Study: Quality Evaluation of Stool Samples Collected for Microbiome Analysis Using the HyGIeaCare Prep
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stool Microbiome
Lead sponsor: HyGIeaCare, Inc.
Sponsor class: INDUSTRY
First posted: 2020-02-11
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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 purpose: BASIC_SCIENCE

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Microbial classification
timeFrame: 6 months
measure: Diversity between stool and colon effluent samples
timeFrame: 6 months
measure: Inner diversity of samples
timeFrame: 6 months
measure: Contribution of the variables to samples' diversity
timeFrame: 6 months
Secondary outcomes:
measure: Functional genes analysis
timeFrame: 6 months
measure: Biosynthetic gene clusters
timeFrame: 6 months
Other outcomes:
Locations:
city: Norfolk
country: United States
facility: HyGIeaCare Center
state: Virginia
Study officials:
affiliation: Eastern Virginia Medical School
name: David A Johnson, MD
role: PRINCIPAL_INVESTIGATOR
References: