ColonoscopyNCT02062112
Improving Tolerability of Bowel Preparation Laxative for Colonoscopy
A study testing Pattern of flavoring of bowel laxative in people with Colonoscopy and Bowel Preparation, run by Howard University at 1 site in United States.
Trial summary
The purpose of this study is to determine whether the pattern of flavoring and drinking of laxatives for colonoscopy can improve the experience of patients when they are undergoing bowel preparation for the test. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Colonoscopy, Bowel Preparation
- What is being tested?
- Pattern of flavoring of bowel laxative
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 313 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Feb 2014to 21 Jan 2015
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (18 years and older) referred for outpatient colonoscopy
Who cannot join
- Patients with history of bowel resection
- patients with history of inflammatory bowel disease
- History of polyposis syndrome
- History of colorectal cancer
- History of poor taste perception from any cause
Trial locations and contacts
1 site in 1 country.
United States1 site
Howard University
Washington D.C., District of Columbia, 20060
About this study
Official title: Comparison of Patterns of Laxative Ingestion to Improve Bowel Preparation for Colonoscopy: A Pilot Randomized Trial
The purpose of this study is to determine whether the pattern of flavoring and drinking of laxatives for colonoscopy can improve the experience of patients when they are undergoing bowel preparation for the test.
Investigators hypothesize that patients will have a better experience if patients taste the bowel preparation laxative with and without flavoring and then decide how they want to drink the rest of the laxative since taste preferences vary widely from person to person.
- Conditions
- Colonoscopy, Bowel Preparation
- Being tested
- Pattern of flavoring of bowel laxative
- Keywords
- Bowel preparation solutions, Colonoscopy, Polyethylene glycol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pattern of flavoring of bowel laxativeOther
Unflavored bowel laxative versus entire bowel laxative flavored versus liberal flavoring as decided by patient
| Study group | Role | What they receive |
|---|---|---|
| Unflavored group | No intervention | The patient will mix 1 gallon of polyethylene glycol with water and drink as directed by his/her endoscopist. No flavoring will be added. |
| Flavored group | Active comparator | The patient will mix 1 gallon of polyethylene glycol with water, add flavoring to the entire solution and drink at the time specified by his/her endoscopist. Receives: Other: Pattern of flavoring of bowel laxative |
| Liberal group | Active comparator | The patient will mix 1 gallon of polyethylene glycol with water. Fill 2 cups with the solution. The patient will add flavoring to one cup and drink both the flavored and unflavored solutions in the cups. The patient will then determine how he/she wants to drink the rest of the bowel preparation laxatives based on their taste preference and drink at the time specified by his/her endoscopist. Receives: Other: Pattern of flavoring of bowel laxative |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall patients' experience with the bowel preparation process with ratings from 1 (unbearable) to 10 (Pleasant)
On the day of the patient's colonoscopy, each patient will complete another form regarding their bowel preparation experience. Information gathered will include their ratings of the bowel preparation laxative's taste, ease of consumption, presence or absence of nausea, vomiting, whether they consumed the entire recommended laxative and their overall ratings of the bowel preparation experience.
Measured: At the time of colonoscopy
Secondary outcomes (1)
Endoscopist ratings of the patient's bowel preparation quality using Aronchick scale
During the colonoscopy, the endoscopist who will be masked to the assignment of the patients will assess the quality of bowel preparation and grade as Poor/Inadequate, Fair, Good, Very Good or Excellent.
Measured: At the colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2014 (estimated)
- Study start11 Feb 2014
- Primary completion21 Jan 2015
- Study completion21 Jan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ColonoscopyStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 313 participants (actual)
Sponsor and investigators
- Lead sponsor
- Howard University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adeyinka O Laiyemo, MD, MPH, Principal investigator, Howard University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02062112
- Sponsor's protocol ID
- IRB-13-MED-60
- Status last verified
- Sep 2018
- First submitted
- 11 Feb 2014
- Last updated
- 14 Sep 2018
- Results posted
- No
Publications
Hayes A, Buffum M, Fuller D. Bowel preparation comparison: flavored versus unflavored colyte. Gastroenterol Nurs. 2003 May-Jun;26(3):106-9. doi: 10.1097/00001610-200305000-00004.
PubMed 12811320
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Patterns of Laxative Ingestion to Improve Bowel Preparation for Colonoscopy: A Pilot Randomized Trial
- ClinicalTrials.gov ID
- NCT02062112
- Acronym / sponsor ID
- IRB-13-MED-60
- Conditions
- Colonoscopy, Bowel Preparation
- Keywords
- Bowel preparation solutions, Colonoscopy, Polyethylene glycol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 313 participants (actual)
- Lead sponsor
- Howard UniversityUniversity, hospital or other
- Study start
- 11 Feb 2014 (actual)
- Primary completion
- 21 Jan 2015 (actual)
- Study completion
- 21 Jan 2015 (actual)
- First posted
- 13 Feb 2014 (estimated)
- 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 purpose of this study is to determine whether the pattern of flavoring and drinking of laxatives for colonoscopy can improve the experience of patients when they are undergoing bowel preparation for the test.
Investigators hypothesize that patients will have a better experience if patients taste the bowel preparation laxative with and without flavoring and then decide how they want to drink the rest of the laxative since taste preferences vary widely from person to person.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Unflavored group | No intervention | –The patient will mix 1 gallon of polyethylene glycol with water and drink as directed by his/her endoscopist. No flavoring will be added. |
| Flavored group | Active comparator | Other: Pattern of flavoring of bowel laxativeThe patient will mix 1 gallon of polyethylene glycol with water, add flavoring to the entire solution and drink at the time specified by his/her endoscopist. |
| Liberal group | Active comparator | Other: Pattern of flavoring of bowel laxativeThe patient will mix 1 gallon of polyethylene glycol with water. Fill 2 cups with the solution. The patient will add flavoring to one cup and drink both the flavored and unflavored solutions in the cups. The patient will then determine how he/she wants to drink the rest of the bowel preparation laxatives based on their taste preference and drink at the time specified by his/her endoscopist. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults (18 years and older) referred for outpatient colonoscopy
Key exclusion criteria (5 listed)
- Patients with history of bowel resection
- patients with history of inflammatory bowel disease
- History of polyposis syndrome
- History of colorectal cancer
- History of poor taste perception from any cause
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 |
|---|---|---|
| Pattern of flavoring of bowel laxativeUnflavored bowel laxative versus entire bowel laxative flavored versus liberal flavoring as decided by patient | Other | Flavored group, Liberal group |
Primary outcome
Overall patients' experience with the bowel preparation process with ratings from 1 (unbearable) to 10 (Pleasant)
Time frame: At the time of colonoscopy
On the day of the patient's colonoscopy, each patient will complete another form regarding their bowel preparation experience. Information gathered will include their ratings of the bowel preparation laxative's taste, ease of consumption, presence or absence of nausea, vomiting, whether they consumed the entire recommended laxative and their overall ratings of the bowel preparation experience.
1 secondary outcome
Endoscopist ratings of the patient's bowel preparation quality using Aronchick scale
Time frame: At the colonoscopy
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 14 Sep 2018.
- Background: PubMed 12811320Hayes A, Buffum M, Fuller D. Bowel preparation comparison: flavored versus unflavored colyte. Gastroenterol Nurs. 2003 May-Jun;26(3):106-9. doi: 10.1097/00001610-200305000-00004.
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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.
Adeyinka O Laiyemo, MD, MPH principal investigator
Howard University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pattern of flavoring of bowel laxative in people with Colonoscopy and Bowel Preparation, run by Howard University 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 5 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 14 Sep 2018. 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?
Overall patients' experience with the bowel preparation process with ratings from 1 (unbearable) to 10 (Pleasant) (time frame: At the time of colonoscopy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02062112, which also lists 1 linked publication.
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 14 Sep 2018.