Microbiome Analysis of Constipated Versus Non-constipation Patients

NCT ID: NCT04106232

Last Updated: 2023-04-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-01-24
• Study Completion Date: 2023-03-06

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 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.

Conditions

Rome IV Functional Constipation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Patient's age is between 18 and 80 years old.

2. For the healthy population - Indication for age-appropriate colorectal cancer screening colonoscopy

3. Adequate capacity to consent to study

4. Patient does not have any known health issues, except for chronic constipation for the "chronic constipation" population.

5. Patient has not taken antibiotics within the last three (3) months.

6. 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

1. Patient has functional bowel disorders characterized by alternating bowel habits (diarrhea/constipation).

2. 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.

3. Current, or recent (within three months) antibiotic usage

Patient has any of the contraindications listed below:

4. Cardiac: Congestive heart failure (NYHA class III or IV or EF <50%)

5. GI: Intestinal perforation, carcinoma of the rectum, fissures or fistula, severe hemorrhoids, abdominal hernia, recent colon or rectal surgery, or abdominal surgery

6. GU: Renal insufficiency (CC < 60 ml/min/173m2), cirrhosis with ascites

7. Abdominal surgery within the last 6 months

8. Pregnancy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

HyGIeaCare, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David A Johnson, MD

Role: PRINCIPAL_INVESTIGATOR

Eastern Virginia Medical School

Locations

Hygieacare Center - Flowood

Flowood, Mississippi, United States

Hygieacare - Norwood

Cincinnati, Ohio, United States

HyGIeaCare Center

Norfolk, Virginia, United States

Countries

United States

Other Identifiers

HGP-0008

Identifier Type: -

Identifier Source: org_study_id