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Microbiome Analysis of Constipated Versus Non-constipation Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04106232
Recruitment Status : Active, not recruiting
First Posted : September 26, 2019
Last Update Posted : August 21, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Rome IV Functional Constipation Other: No change in procedure except for specimen collection throughout procedure

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.

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: MIcrobiome Analysis of Chronically Constipated Versus Non-constipated Populations for Detection of Novel Molecular Entities With Therapeutic Potential
Actual Study Start Date : January 24, 2020
Estimated Primary Completion Date : July 24, 2022
Estimated Study Completion Date : September 24, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation


Intervention Details:
  • 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


Primary Outcome Measures :
  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.


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).


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy volunteers and chronically constipated patients
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04106232


Locations
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United States, Virginia
HyGIeaCare Center
Norfolk, Virginia, United States, 23502
Sponsors and Collaborators
HyGIeaCare, Inc.
Investigators
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Principal Investigator: David A Johnson, MD Eastern Virginia Medical School
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Responsible Party: HyGIeaCare, Inc.
ClinicalTrials.gov Identifier: NCT04106232    
Other Study ID Numbers: HGP-0008
First Posted: September 26, 2019    Key Record Dates
Last Update Posted: August 21, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Outcomes will be used internally for future studies.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Constipation
Signs and Symptoms, Digestive