Skip to main content
OpenTrials
Completed

NCT Number: NCT04106232

Microbiome Analysis of Constipated Versus Non-constipation Patients

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hygieacare Center - Flowood, Flowood, Mississippi, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

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

Primary outcomes

  1. Identify the presence of microbial substances within stool samples taken from different locations along the colon

    Time frame: 12 months

    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.

Sponsors and collaborators

Lead sponsor

HyGIeaCare, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Sep 26, 2019
Registry last updated
Apr 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.