Microbiome Analysis of Constipated Versus Non-constipation Patients

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

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

Study Overview

• Status: Completed
• Conditions: Rome IV Functional Constipation
• Intervention / Treatment: Other: No change in procedure except for specimen collection throughout procedure

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.

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• United States
  • Mississippi
    • Flowood, Mississippi, United States, 39232
      • Hygieacare Center - Flowood
  • Ohio
    • Cincinnati, Ohio, United States, 45212
      • Hygieacare - Norwood
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • HyGIeaCare Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Healthy volunteers and chronically constipated patients

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: HyGIeaCare, Inc.
• Investigators: Principal Investigator: David A Johnson, MD, Eastern Virginia Medical School

Study record dates

Study Major Dates

• Study Start (Actual): January 24, 2020
• Primary Completion (Actual): March 6, 2023
• Study Completion (Actual): March 6, 2023

Study Registration Dates

• First Submitted: September 20, 2019
• First Submitted That Met QC Criteria: September 25, 2019
• First Posted (Actual): September 26, 2019

Study Record Updates

• Last Update Posted (Actual): April 27, 2023
• Last Update Submitted That Met QC Criteria: April 26, 2023
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Constipation
• Other Study ID Numbers: HGP-0008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Outcomes will be used internally for future studies.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No