Stool Microbiome
Conditions
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.
Interventions
OTHERHyGIeaCare Prep
Each patient will have up to 5 stool specimens for evaluation by a lab for microbial contents.
Sponsors
HyGIeaCare, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Microbial classification | 6 months | The number of genes present will be counted |
| Diversity between stool and colon effluent samples | 6 months | Alpha diversity by Shannon diversity index, presence and number of taxa to be documented |
| Inner diversity of samples | 6 months | ANOVA test will be used to acknowledge differences between samples, presence and number of taxa to be documented |
| Contribution of the variables to samples' diversity | 6 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional genes analysis | 6 months | The presence of genes known to represent biochemical functions will be counted and documented |
| Biosynthetic gene clusters | 6 months | Groups of genes with known biosynthetic functions and found to be clustered will be counted and documented together in the different samples |
Countries
United States
Outcome results
None listed