Microbiome Analysis of Constipated Versus Non-constipation Patients
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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.
Condition or disease
Rome IV Functional Constipation
Other: No change in procedure except for specimen collection throughout procedure
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.
Identify the presence of microbial substances within stool samples taken from different locations along the colon [ Time Frame: 12 months ]
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.
Biospecimen Retention: Samples With DNA
Overall, we expect to enroll 20 subjects. Each volunteer or patient will provide a traditional stool sample ("spot sample"), collected in their home. During the HyGIeaCare prep, we will collect up to 3 samples from each patient (unless we will need an "initial" one from the constipated population).
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Layout table for eligibility information
Ages Eligible for Study:
18 Years to 80 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Healthy volunteers and chronically constipated patients
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.
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