Stool MicrobiomeNCT04264923
Evaluation of Stool Microbiome Using HyGIeaCare Prep
A study testing HyGIeaCare Prep in people with Stool Microbiome, run by HyGIeaCare, Inc. at 1 site in United States.
Trial summary
Stool samples will be collected before and during the HyGIeaCare procedure and the samples will be sent for microbiome evaluation. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Stool Microbiome
- What is being tested?
- HyGIeaCare Prep
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jun 2019to 30 Jun 2020
- Phase
- Interventional
- 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
Who may be able to join
- Patient's age is between 18 and 80 years old scheduled for elective screening or polyp surveillance indicated colonoscopy
- Patient does not have any known health issues (as listed in exclusion criteria)
- Patient had not taken antibiotics within the last 2 months
Who cannot join
- Patient has functional bowel disorders characterized by alternating bowel habits (diarrhea/constipation), chronic diarrhea or chronic constipation (requiring pharmacologic prescription treatment)
- Patient has secondary constipation (colonic obstruction, medications, metabolic cause)
- 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
- 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, inflammatory bowel disease. History of gastrointestinal surgery- (small bowel, colon. Bariatric 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
1 site in 1 country.
About this study
Official title: Pilot Study: Quality Evaluation of Stool Samples Collected for Microbiome Analysis Using the HyGIeaCare Prep
Stool samples will be collected before and during the HyGIeaCare procedure and the samples will be sent for microbiome evaluation.
Read the detailed description
Patients will have the HyGIeaCare procedure as originally prescribed by their physician. Before and during the procedure stool samples will be collected and sent to a lab for microbiome evaluation.
It is anticipated that stool samples collected from the HyGIeaCare prep will provide more microbiological and biochemical information on the gut interior than using traditional stool samples.
- Conditions
- Stool Microbiome
- Being tested
- HyGIeaCare Prep
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HyGIeaCare PrepOther
Also called Stool sample evaluation
Each patient will have up to 5 stool specimens for evaluation by a lab for microbial contents.
| Study group | Role | What they receive |
|---|---|---|
| All patients enrolled | Experimental | All patients enrolled with receive the HyGIeaCare Prep with a new lab sampling technique to be used on all patients enrolled in the study. Receives: Other: HyGIeaCare Prep |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbial classification
The number of genes present will be counted
Measured: 6 months
Diversity between stool and colon effluent samples
Alpha diversity by Shannon diversity index, presence and number of taxa to be documented
Measured: 6 months
Inner diversity of samples
ANOVA test will be used to acknowledge differences between samples, presence and number of taxa to be documented
Measured: 6 months
Contribution of the variables to samples' diversity
Principal component analysis (PCoA) will be used to mark significant differences between the samples, taxa will be identified by presence, percentage of sample will be documented
Measured: 6 months
Secondary outcomes (2)
Functional genes analysis
The presence of genes known to represent biochemical functions will be counted and documented
Measured: 6 months
Biosynthetic gene clusters
Groups of genes with known biosynthetic functions and found to be clustered will be counted and documented together in the different samples
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2020
- Study start27 Jun 2019
- Primary completion19 Dec 2019
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stool MicrobiomeStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patients between 18 and 80 years old who do not have any known health issues and who have not taken antibiotics within the last two months.
- Masking
- None (open label)
- Enrolment
- 14 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
- NCT04264923
- Sponsor's protocol ID
- HGP-0002
- Status last verified
- Jun 2019
- First submitted
- 24 Jul 2019
- Last updated
- 31 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Initially the data will be used internally.
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study: Quality Evaluation of Stool Samples Collected for Microbiome Analysis Using the HyGIeaCare Prep
- ClinicalTrials.gov ID
- NCT04264923
- Acronym / sponsor ID
- HGP-0002
- Conditions
- Stool Microbiome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- HyGIeaCare, Inc.Industry (pharma, biotech, devices)
- Study start
- 27 Jun 2019 (actual)
- Primary completion
- 19 Dec 2019 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 11 Feb 2020 (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.
Stool samples will be collected before and during the HyGIeaCare procedure and the samples will be sent for microbiome evaluation.
Detailed description
Patients will have the HyGIeaCare procedure as originally prescribed by their physician. Before and during the procedure stool samples will be collected and sent to a lab for microbiome evaluation.
It is anticipated that stool samples collected from the HyGIeaCare prep will provide more microbiological and biochemical information on the gut interior than using traditional stool samples.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients between 18 and 80 years old who do not have any known health issues and who have not taken antibiotics within the last two months.
| Arm | Type | Receives |
|---|---|---|
| All patients enrolled | Experimental | Other: HyGIeaCare PrepAll patients enrolled with receive the HyGIeaCare Prep with a new lab sampling technique to be used on all patients enrolled in the study. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient's age is between 18 and 80 years old scheduled for elective screening or polyp surveillance indicated colonoscopy
- Patient does not have any known health issues (as listed in exclusion criteria)
- Patient had not taken antibiotics within the last 2 months
Key exclusion criteria (9 listed)
- Patient has functional bowel disorders characterized by alternating bowel habits (diarrhea/constipation), chronic diarrhea or chronic constipation (requiring pharmacologic prescription treatment)
- Patient has secondary constipation (colonic obstruction, medications, metabolic cause)
- 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
- Patient has any of the contraindications listed below:
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 |
|---|---|---|
| HyGIeaCare PrepAlso: Stool sample evaluationEach patient will have up to 5 stool specimens for evaluation by a lab for microbial contents. | Other | All patients enrolled |
Primary outcome
Microbial classification
Time frame: 6 months
The number of genes present will be counted
Diversity between stool and colon effluent samples
Time frame: 6 months
Alpha diversity by Shannon diversity index, presence and number of taxa to be documented
Inner diversity of samples
Time frame: 6 months
ANOVA test will be used to acknowledge differences between samples, presence and number of taxa to be documented
Contribution of the variables to samples' diversity
Time frame: 6 months
Principal component analysis (PCoA) will be used to mark significant differences between the samples, taxa will be identified by presence, percentage of sample will be documented
2 secondary outcomes
Functional genes analysis
Time frame: 6 months
Biosynthetic gene clusters
Time frame: 6 months
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 31 Jul 2020.
- Individual participant dataSharing planned: No. Initially the data will be used internally.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HyGIeaCare Prep in people with Stool Microbiome, run by HyGIeaCare, Inc. at 1 site 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 3 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 31 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Microbial classification (time frame: 6 months). The study lists 4 primary outcomes in all. 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 31 Jul 2020.