Microbiome Analysis of Constipated Versus Non-constipation Patients

Completed

• Conditions: Rome IV Functional Constipation

• Registration Number: NCT04106232
• Lead Sponsor: HyGIeaCare, Inc.

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.

Study Timeline

• Study First Submitted: 2019-09-20
• Study First Submitted QC: 2019-09-25
• Study First Posted: 2019-09-26
• Study Start: 2020-01-24
• Status Verified: 2022-11
• Primary Completion: 2023-03-06
• Study Completion: 2023-03-06
• Last Update Submitted: 2023-04-26
• Last Update Posted: 2023-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (3)

Hygieacare Center - Flowood; 🇺🇸 Flowood, Mississippi, United States

Hygieacare - Norwood; 🇺🇸 Cincinnati, Ohio, United States

HyGIeaCare Center; 🇺🇸 Norfolk, Virginia, United States