Rome IV Functional ConstipationNCT04106232
Microbiome Analysis of Constipated Versus Non-constipation Patients
An observational study of Rome IV Functional Constipation, run by HyGIeaCare, Inc. at 3 sites in United States.
Trial summary
This study intends to evaluate the microbiome of chronically constipated patients as compared to those with a non-constipated gastrointestinal system. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Rome IV Functional Constipation
- What is being tested?
- No change in procedure except for specimen collection throughout procedure
- How many people
- 30 participants
- Where
- 3 sitesUnited States
- Study dates
- 24 Jan 2020to 6 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy volunteers and chronically constipated patients
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- GU: Renal insufficiency (CC < 60 ml/min/173m2), cirrhosis with ascites
- Abdominal surgery within the last 6 months
- Pregnancy
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Hygieacare - Norwood
Cincinnati, Ohio, 45212
Hygieacare Center - Flowood
Flowood, Mississippi, 39232
HyGIeaCare Center
Norfolk, Virginia, 23502
About this study
Official title: MIcrobiome Analysis of Chronically Constipated Versus Non-constipated Populations for Detection of Novel Molecular Entities With Therapeutic Potential
This study intends to evaluate the microbiome of chronically constipated patients as compared to those with a non-constipated gastrointestinal system.
Read the 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.
- Conditions
- Rome IV Functional Constipation
- Being tested
- No change in procedure except for specimen collection throughout procedure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No change in procedure except for specimen collection throughout procedureOther
Stool specimens will be taken before and during the HyGIeaCare procedure. Microbiome comparisons will be made across all specimens
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2019
- Study start24 Jan 2020
- Primary completion6 Mar 2023
- Study completion6 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rome IV Functional ConstipationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- HyGIeaCare, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David A Johnson, MD, Principal investigator, Eastern Virginia Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04106232
- Sponsor's protocol ID
- HGP-0008
- Status last verified
- Nov 2022
- First submitted
- 20 Sep 2019
- Last updated
- 27 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Outcomes will be used internally for future studies.
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MIcrobiome Analysis of Chronically Constipated Versus Non-constipated Populations for Detection of Novel Molecular Entities With Therapeutic Potential
- ClinicalTrials.gov ID
- NCT04106232
- Acronym / sponsor ID
- HGP-0008
- Conditions
- Rome IV Functional Constipation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- HyGIeaCare, Inc.Industry (pharma, biotech, devices)
- Study start
- 24 Jan 2020 (actual)
- Primary completion
- 6 Mar 2023 (actual)
- Study completion
- 6 Mar 2023 (actual)
- First posted
- 26 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy volunteers and chronically constipated patients
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No change in procedure except for specimen collection throughout procedureStool specimens will be taken before and during the HyGIeaCare procedure. Microbiome comparisons will be made across all specimens | Other | – |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2023.
- Individual participant dataSharing planned: No. Outcomes will be used internally for future studies.
Related trials for Rome IV Functional Constipation
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David A Johnson, MD principal investigator
Eastern Virginia Medical School
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rome IV Functional Constipation, run by HyGIeaCare, Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identify the presence of microbial substances within stool samples taken from different locations along the colon (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2023.