Microbiome Analysis of Constipated Versus Non-constipation Patients

Rome IV Functional Constipation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04106232
• Other study ID #: HGP-0008
• Status: Completed
• Start date: January 24, 2020
• Est. completion date: March 6, 2023

Study information

• Verified date: November 2022
• Source: HyGIeaCare, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 6, 2023
• Est. primary completion date: March 6, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Constipation
• Rome IV Functional Constipation

Intervention

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

Locations

Country	Name	City	State
United States	Hygieacare - Norwood	Cincinnati	Ohio
United States	Hygieacare Center - Flowood	Flowood	Mississippi
United States	HyGIeaCare Center	Norfolk	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
HyGIeaCare, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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