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Stool samples will be collected before and during the HyGIeaCare procedure and the samples will be sent for microbiome evaluation.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All patients enrolled | Experimental | All patients enrolled with receive the HyGIeaCare Prep with a new lab sampling technique to be used on all patients enrolled in the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HyGIeaCare Prep | Other | Each patient will have up to 5 stool specimens for evaluation by a lab for microbial contents. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Microbial classification | The number of genes present will be counted | 6 months |
| Diversity between stool and colon effluent samples | Alpha diversity by Shannon diversity index, presence and number of taxa to be documented | 6 months |
| Inner diversity of samples | ANOVA test will be used to acknowledge differences between samples, presence and number of taxa to be documented | 6 months |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Functional genes analysis | The presence of genes known to represent biochemical functions will be counted and documented | 6 months |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Patient has functional bowel disorders characterized by alternating bowel habits (diarrhea/constipation), chronic diarrhea or chronic constipation (requiring pharmacologic prescription treatment)
Patient has secondary constipation (colonic obstruction, medications, metabolic cause)
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
Patient has any of the contraindications listed below:
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| Name | Affiliation | Role |
|---|---|---|
| David A Johnson, MD | Eastern Virginia Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HyGIeaCare Center | Norfolk | Virginia | 78744 | United States |
Initially the data will be used internally.
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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.
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| 6 months |