Colonoscopy PreparationNCT04150133
Effects and Tolerability With Clenpiq and Low Residue Diet
A study testing Low Residue Diet in people with Colonoscopy Preparation, run by Hillmont GI at 1 site in United States.
Trial summary
The Efficacy of Clenpiq utilized per FDA labeling, with a low residue diet the day before colonoscopy. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Colonoscopy Preparation
- What is being tested?
- Low Residue Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Nov 2019to 1 Oct 2021
- 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
- All subjects age 18-80 requiring colonoscopy for appropriate indications
Who cannot join
- Active diarrhea (Greater than 3 unformed stools daily)
- Constipation (Less than 3 spontaneous bowel movements per week) Each within 2 weeks of the scheduled Colonoscopy.
- Additional exclusion criteria would include;
- Subjects with a history of inflammatory bowel disease
- Colonic resection of any length
- Pregnant women
Show all 10Show fewer
- American Society of Anesthesiologists (ASA) score greater than 3
- Body Mass Index (BMI) greater than 50
- Previous reaction to this bowel preparation or contraindications to taking Clenpiq per the package labeling guidelines.
- Subjects unable to give their own informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects and Tolerability of a Prescribed Low Residue Diet the Day Before Colonoscopy on the Cleanliness of the Colon vs. the Traditional Clear Liquid, Day Before Diet With the Use of the Clenpiq Bowel Purgative
The Efficacy of Clenpiq utilized per FDA labeling, with a low residue diet the day before colonoscopy.
Read the detailed description
This study proposes to assess the use of a low residue diet of a prescribed nature the day before colonoscopy for breakfast, lunch and early dinner. Clinical outcomes utilizing the low residue diet will be compared to the Food and Drug Administration (FDA) approved split dose labeling, including the traditional clear liquid diet the day before colonoscopy utilizing the Clenpiq (Ferring Pharmaceuticals) bowel preparation.
- Conditions
- Colonoscopy Preparation
- Being tested
- Low Residue Diet
- Keywords
- low residue diet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Residue DietOther
Variable cohort will eat 3 low residue meals on the day prior to their planned colonoscopy
| Study group | Role | What they receive |
|---|---|---|
| Traditional Clear Liquid Arm | Active comparator | Following instructions with FDA-labeled clear liquids Receives: Other: Low Residue Diet |
| Low Residue Diet Arm | Experimental | Following instructions for a low residue diet along with FDA-labeled clear liquids Receives: Other: Low Residue Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Statistical equivalence of the clear liquid and low residue cohorts
Using the Boston Bowel Preparation Score, the 3 sections of the colon will be graded on adequacy of preparation at the colonoscopy
Measured: During Colonoscopy Up to 24 hours
Secondary outcomes (1)
Polyp Detection Rate
Number of polyps detected and removed per total number of patients in each arm
Measured: Post Procedure Up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2019
- Study start21 Nov 2019
- Primary completion1 Jan 2021
- Study completion1 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonoscopy PreparationStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- single blind trial of FDA approved preparation with per labeling clear liquid diet versus a single day low residue diet
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hillmont GI
- Sponsor type
- University, hospital or other
- Collaborators
- Ferring Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Gerald Bertiger, MD, Principal investigator, Hillmont GI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04150133
- Sponsor's protocol ID
- foodprep2019
- Status last verified
- Mar 2022
- First submitted
- 24 Oct 2019
- Last updated
- 16 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects and Tolerability of a Prescribed Low Residue Diet the Day Before Colonoscopy on the Cleanliness of the Colon vs. the Traditional Clear Liquid, Day Before Diet With the Use of the Clenpiq Bowel Purgative
- ClinicalTrials.gov ID
- NCT04150133
- Acronym / sponsor ID
- foodprep2019
- Conditions
- Colonoscopy Preparation
- Keywords
- low residue diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Hillmont GIUniversity, hospital or other
- Collaborators
- Ferring Pharmaceuticals
- Study start
- 21 Nov 2019 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 4 Nov 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.
The Efficacy of Clenpiq utilized per FDA labeling, with a low residue diet the day before colonoscopy.
Detailed description
This study proposes to assess the use of a low residue diet of a prescribed nature the day before colonoscopy for breakfast, lunch and early dinner. Clinical outcomes utilizing the low residue diet will be compared to the Food and Drug Administration (FDA) approved split dose labeling, including the traditional clear liquid diet the day before colonoscopy utilizing the Clenpiq (Ferring Pharmaceuticals) bowel preparation.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- single blind trial of FDA approved preparation with per labeling clear liquid diet versus a single day low residue diet
| Arm | Type | Receives |
|---|---|---|
| Traditional Clear Liquid Arm | Active comparator | Other: Low Residue DietFollowing instructions with FDA-labeled clear liquids |
| Low Residue Diet Arm | Experimental | Other: Low Residue DietFollowing instructions for a low residue diet along with FDA-labeled clear liquids |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All subjects age 18-80 requiring colonoscopy for appropriate indications
Key exclusion criteria (10 listed)
- Active diarrhea (Greater than 3 unformed stools daily)
- Constipation (Less than 3 spontaneous bowel movements per week) Each within 2 weeks of the scheduled Colonoscopy.
- Additional exclusion criteria would include;
- Subjects with a history of inflammatory bowel disease
- Colonic resection of any length
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 |
|---|---|---|
| Low Residue DietVariable cohort will eat 3 low residue meals on the day prior to their planned colonoscopy | Other | Low Residue Diet Arm, Traditional Clear Liquid Arm |
Primary outcome
Statistical equivalence of the clear liquid and low residue cohorts
Time frame: During Colonoscopy Up to 24 hours
Using the Boston Bowel Preparation Score, the 3 sections of the colon will be graded on adequacy of preparation at the colonoscopy
1 secondary outcome
Polyp Detection Rate
Time frame: Post Procedure Up to 24 hours
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 16 Mar 2022.
- 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.
Gerald Bertiger, MD principal investigator
Hillmont GI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Residue Diet in people with Colonoscopy Preparation, run by Hillmont GI 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 1 inclusion and 10 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 16 Mar 2022. 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?
Statistical equivalence of the clear liquid and low residue cohorts (time frame: During Colonoscopy Up to 24 hours). 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 16 Mar 2022.