Microbiome Analysis of Constipated Versus Non-constipation Patients

NCT04106232 | Completed

• 1 other identifier: HGP-0008
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Rome IV Functional Constipation

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

No change in procedure except for specimen collection throughout procedure OTHER

Stool specimens will be taken before and during the HyGIeaCare procedure. Microbiome comparisons will be made across all specimens

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy volunteers and chronically constipated patients

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• HyGIeaCare, Inc.: lead

Study Sites (3)

Hygieacare Center - Flowood

Flowood, Mississippi, 39232, United States

Location

Hygieacare - Norwood

Cincinnati, Ohio, 45212, United States

Location

HyGIeaCare Center

Norfolk, Virginia, 23502, United States

Location

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).

Study Officials

• David A Johnson, MD

  Eastern Virginia Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2019
• First Posted: September 26, 2019
• Study Start: January 24, 2020
• Primary Completion: March 6, 2023
• Study Completion: March 6, 2023
• Last Updated: April 27, 2023

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)