Rome IV Functional ConstipationNCT04532879
HygiRelief Procedure and HygiSample Evaluation for Functional Constipation
A study testing HygiPrep (HyGIeaCare System) in people with Rome IV Functional Constipation, run by HyGIeaCare, Inc..
Trial summary
This study has a single center, prospective, open label design. The population will include patients diagnosed with Rome IV Functional Constipation who are at the time of study enrollment being managed with a stable dose of Linzess. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rome IV Functional Constipation
- What is being tested?
- HygiPrep (HyGIeaCare System)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2021to Jun 2022
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient's age is between 18 and 80 years old
- Patient diagnosed with Rome IV Functional Constipation (Attachment C2)
- Patient is currently managed with Linzess and willing to stop taking it for study duration
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
- 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, rectal, or abdominal surgery
- GU: Renal insufficiency (CC < 60 ml/min/173m2), cirrhosis with ascites
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- Abdominal surgery within the last 6 months
- Pregnancy
- Patient took antibiotics within two months of starting the study
About this study
Official title: HygiRelief Procedure and HygiSample Evaluation for Patients Diagnosed With Rome IV Functional Constipation Previously Managed With Linzess
This study has a single center, prospective, open label design. The population will include patients diagnosed with Rome IV Functional Constipation who are at the time of study enrollment being managed with a stable dose of Linzess. They will stop taking their Linzess, undergo monitoring of bowel habits for 2 weeks, have a HygiRelief procedure and then undergo an additional 2 weeks of bowel habit monitoring.
Read the detailed description
After undergoing a 5-7 day Linzess washout period, patients will record their bowel habits in a daily diary for 2 weeks. Patients will have the HygiRelief procedure with a HygiSample evaluation, then they will record their bowel habits in a daily diary for 2 weeks following the HygiRelief procedure.
HygiSamples (stool samples) will be collected throughout the HygiRelief procedure and the samples will be sent for microbiome evaluation.
Patients will complete multiple questionnaires - Happiness Scale, Hospital Anxiety and Depression Scale (HADS), and a personal assessment which includes the Constipation Symptom Score and Adverse Event Screening. These will be completed at Baseline, after the 2 week PRE-HygiRelief period, and after the 2 week POST-HygiRelief period.
- Conditions
- Rome IV Functional Constipation
- Being tested
- HygiPrep (HyGIeaCare System)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HygiPrep (HyGIeaCare System)Device
Also called HygiSample (stool collection for microbiome evaluation)
Controlled gravity-based high-volume colon irrigation
| Study group | Role | What they receive |
|---|---|---|
| All patients enrolled | Experimental | Bowel habits before and after the HygiRelief procedure will be assessed.
Samples will be sent for microbiome evaluation. Receives: Device: HygiPrep (HyGIeaCare System) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess change in bowel movements PRE and POST HygiRelief procedure
Evaluate the clinical effectiveness of the HygiRelief procedure to relieve functional constipation in patients previously managed with a stable dose of Lizess
Measured: 12 months
Secondary outcomes (1)
Assess colon effluent samples (HygiSample) collected during the HygiRelief procedure
Samples will be evaluated for their microbiological and biochemical content, as well as to identify microbiome changes throughout the colon
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 posted31 Aug 2020
- Study startSep 2021 (estimated)
- Primary completionMar 2022 (estimated)
- Study completionJun 2022 (estimated)
Why it stopped: decided not to do the study due to Covid staffing restrictions
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, single center, open label. Patients will serve as their own control by comparing their bowel habits using a specific diary 2 weeks after the Linzess washout period to the 2 weeks after their HygiRelief procedure.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- HyGIeaCare, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04532879
- Sponsor's protocol ID
- HGP-0009
- Status last verified
- Sep 2021
- First submitted
- 20 Aug 2020
- Last updated
- 17 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HygiRelief Procedure and HygiSample Evaluation for Patients Diagnosed With Rome IV Functional Constipation Previously Managed With Linzess
- ClinicalTrials.gov ID
- NCT04532879
- Acronym / sponsor ID
- HGP-0009
- Conditions
- Rome IV Functional Constipation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: decided not to do the study due to Covid staffing restrictions
- Enrolment
- 0 participants (actual)
- Lead sponsor
- HyGIeaCare, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2021 (estimated)
- Primary completion
- Mar 2022 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 31 Aug 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.
This study has a single center, prospective, open label design. The population will include patients diagnosed with Rome IV Functional Constipation who are at the time of study enrollment being managed with a stable dose of Linzess. They will stop taking their Linzess, undergo monitoring of bowel habits for 2 weeks, have a HygiRelief procedure and then undergo an additional 2 weeks of bowel habit monitoring.
Detailed description
After undergoing a 5-7 day Linzess washout period, patients will record their bowel habits in a daily diary for 2 weeks. Patients will have the HygiRelief procedure with a HygiSample evaluation, then they will record their bowel habits in a daily diary for 2 weeks following the HygiRelief procedure.
HygiSamples (stool samples) will be collected throughout the HygiRelief procedure and the samples will be sent for microbiome evaluation.
Patients will complete multiple questionnaires - Happiness Scale, Hospital Anxiety and Depression Scale (HADS), and a personal assessment which includes the Constipation Symptom Score and Adverse Event Screening. These will be completed at Baseline, after the 2 week PRE-HygiRelief period, and after the 2 week POST-HygiRelief period.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, single center, open label. Patients will serve as their own control by comparing their bowel habits using a specific diary 2 weeks after the Linzess washout period to the 2 weeks after their HygiRelief procedure.
| Arm | Type | Receives |
|---|---|---|
| All patients enrolled | Experimental | Device: HygiPrep (HyGIeaCare System)Bowel habits before and after the HygiRelief procedure will be assessed. Samples will be sent for microbiome evaluation. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient's age is between 18 and 80 years old
- Patient diagnosed with Rome IV Functional Constipation (Attachment C2)
- Patient is currently managed with Linzess and willing to stop taking it for study duration
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
- Patient has any of the contraindications listed below:
- Patient took antibiotics within two months of starting the study
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 |
|---|---|---|
| HygiPrep (HyGIeaCare System)Also: HygiSample (stool collection for microbiome evaluation)Controlled gravity-based high-volume colon irrigation | Device | All patients enrolled |
Primary outcome
Assess change in bowel movements PRE and POST HygiRelief procedure
Time frame: 12 months
Evaluate the clinical effectiveness of the HygiRelief procedure to relieve functional constipation in patients previously managed with a stable dose of Lizess
1 secondary outcome
Assess colon effluent samples (HygiSample) collected during the HygiRelief procedure
Time frame: 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2021.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing HygiPrep (HyGIeaCare System) in people with Rome IV Functional Constipation, run by HyGIeaCare, Inc..
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: withdrawn, as of the sponsor's last update on 17 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Assess change in bowel movements PRE and POST HygiRelief procedure (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 17 Sep 2021.