Microbiome Analysis of Constipated Versus Non-constipation Patients

Study Overview
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Brief Summary
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This study intends to evaluate the microbiome of chronically constipated patients as compared to those with a non-constipated gastrointestinal system.

Detailed Description
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Biogeographically accurate microbiome sampling using the HyGIeaCare platform and an evolutionary biology informed learning platform will allow an improved discovery of bacterially derived novel molecular entities with therapeutic potential for chronic constipation. This approach intends to enhance our ability to understand the gut microbiome and use it towards developing therapeutic solutions, in comparison to traditional collection methods and taxonomic-based data analysis approaches.

Official Title
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MIcrobiome Analysis of Chronically Constipated Versus Non-constipated Populations for Detection of Novel Molecular Entities With Therapeutic Potential

Conditions
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Rome IV Functional Constipation

Intervention / Treatment
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* Other: No change in procedure except for specimen collection throughout procedure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient's age is between 18 and 80 years old. For the healthy population - Indication for age-appropriate colorectal cancer screening colonoscopy Adequate capacity to consent to study Patient does not have any known health issues, except for chronic constipation for the chronic constipation population. Patient has not taken antibiotics within the last three (3) months. For chronically constipated patients - >3 months of symptomatic constipation with first onset of constipation more than 6 months ago. For chronically constipated patients - Diagnosis of functional constipation by Modified Rome IV Diagnostic Criteria. Exclusion Criteria: Patient has functional bowel disorders characterized by alternating bowel habits (diarrhea/constipation). 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. Current, or recent (within three months) antibiotic usage Patient has any of the contraindications listed below: Cardiac: Congestive heart failure (NYHA class III or IV or EF <50%) GI: Intestinal perforation, carcinoma of the rectum, fissures or fistula, severe hemorrhoids, abdominal hernia, recent colon or rectal surgery, or abdominal surgery GU: Renal insufficiency (CC < 60 ml/min/173m2), cirrhosis with ascites Abdominal surgery within the last 6 months Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: No change in procedure except for specimen collection throughout procedure|Stool specimens will be taken before and during the HyGIeaCare procedure. Microbiome comparisons will be made across all specimens|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identify the presence of microbial substances within stool samples taken from different locations along the colon | Finding novel molecular entities with therapeutic potential for chronic constipation using the unique HyGIeaCare approach for constipation relief and collection of fecal material for analysis. | 12 months |