Microbiome Analysis of Constipated Versus Non-constipatio... | NCT04106232

Studies
Microbiome Analysis of Constipated Versus Non-constipation Patients

NCT04106232

Sponsor

HyGIeaCare, Inc.

Status

Completed

Last Update Posted

Apr 27, 2023Actual

Enrollment

30Actual

Phase

Not provided

Conditions

Rome IV Functional Constipation

Interventions

No change in procedure except for specimen collection throughout procedure

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 24, 2020Actual

Primary Completion Date

Mar 6, 2023Actual

Completion Date

Mar 6, 2023Actual

First Submitted Date

Sep 20, 2019

First Submission Date that Met QC Criteria

Sep 25, 2019

First Posted Date

Sep 26, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 26, 2023

Last Update Posted Date

Apr 27, 2023Actual

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

30Actual

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Healthy volunteers and chronically constipated patients

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Hygieacare Center - Flowood		Flowood	Mississippi	39232	United States
Hygieacare - Norwood