Status:
COMPLETED
Microbiome Analysis of Constipated Versus Non-constipation Patients
Lead Sponsor:
HyGIeaCare, Inc.
Conditions:
Rome IV Functional Constipation
Eligibility:
All Genders
18-80 years
Brief Summary
This study intends to evaluate the microbiome of chronically constipated patients as compared to those with a non-constipated gastrointestinal system.
Detailed Description
Biogeographically accurate microbiome sampling using the HyGIeaCare platform and an evolutionary biology informed learning platform will allow an improved discovery of bacterially derived novel molecu...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 24 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 6 2023
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04106232
Start Date
January 24 2020
End Date
March 6 2023
Last Update
April 27 2023
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Hygieacare Center - Flowood
Flowood, Mississippi, United States, 39232
2
Hygieacare - Norwood
Cincinnati, Ohio, United States, 45212
3
HyGIeaCare Center
Norfolk, Virginia, United States, 23502