Bowel PreparationNCT02174497
One-Day Versus Three-Day Bowel Preparation for Colonoscopy in Children
An observational study of Bowel Preparation and Pediatric Colonoscopy, run by St. John Health System, Michigan at 1 site in United States.
Trial summary
This was a blinded study conducted on the efficacy and safety of a one-day versus a three-day bowel preparation in a pediatric population. Limited data is available in this regard, and this study supports the use of a one-day bowel preparation, as this is both safe and effective. Read more about this study
- Who is it for?
- Ages 2 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Bowel Preparation, Pediatric Colonoscopy
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to Jun 2010
- 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 2 to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Children between 2 and 21 years of age undergoing elective colonoscopy were enrolled into the study.
Who may be able to join
- Pediatric Patients referred for an outpatient colonoscopy
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
St. John Hospital and Medical Center
Detroit, Michigan, 48236
About this study
Official title: One-Day Bowel Preparation With Polyethylene Glycol 3350 (Miralax®) is as Effective and Safe as Three-Day Preparation for Colonoscopy in Children
This was a blinded study conducted on the efficacy and safety of a one-day versus a three-day bowel preparation in a pediatric population. Limited data is available in this regard, and this study supports the use of a one-day bowel preparation, as this is both safe and effective.
Read the detailed description
Colonoscopy in children and young adults is performed by gastroenterologists for a variety of indications, including but not limited to evaluation of rectal bleeding, chronic diarrhea, family history of polyposis syndromes and surveillance for colon cancer in patients with inflammatory bowel disease. A successful bowel preparation that enables clear visualization of the intestinal mucosa is essential to diagnose and treat the underlying pathology. Currently, gastroenterologists use a variety of colon cleansing preparations, but Polyethylene Glycol (PEG) 3350 given for three to four days appears to be standard. Though it is well tolerated, safe and effective the duration of preparation may cause disruption to the routine and missed school days. To date, there is limited data that shows efficacy of a shorter duration of bowel preparation with PEG. This study aims to compare the efficacy and safety of a one-day preparation with that of a three-day preparation with PEG 3350 as preparation for colonoscopy in children and young adults.
- Conditions
- Bowel Preparation, Pediatric Colonoscopy
- Keywords
- Pediatric Colonoscopy, Bowel Preparation, Safety, Tolerability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control | Three day Bowel Preparation | |
| Study Arm | One day Bowel Preparation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of a one day versus a three day colonoscopy preparation in a pediatric population
The Safety of the different preparations was documented by monitoring serum electrolytes before and after the preparation.
Measured: 02/08-06/10 (28 months)
Secondary outcomes (1)
Tolerability of a one day versus a three day colonoscopy preparation in a pediatric population
The tolerability was documented by monitoring the patient's clinical ability to consume the entire colonoscopy preparation without abdominal pain, nausea or vomiting. Furthermore, this was objectively documented by monitoring and recording the following parameters: Ease of Administration, Compliance, Willingness to take again
Measured: 02/08-06/10 (28 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2014 (estimated)
- Study startFeb 2008
- Primary completionJun 2010
- Study completionJun 2010
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 Bowel 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. John Health System, Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hernando Lyons, MD, St. John Health System, Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02174497
- Sponsor's protocol ID
- OMB No 0925-0586
- Status last verified
- Jun 2014
- First submitted
- 21 May 2014
- Last updated
- 25 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sorser SA, Konanki V, Hursh A, Hagglund K, Lyons H. 1-day bowel preparation with polyethylene glycol 3350 is as effective and safe as a 3-day preparation for colonoscopy in children. BMC Res Notes. 2014 Sep 15;7:648. doi: 10.1186/1756-0500-7-648.
PubMed 25223547
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One-Day Bowel Preparation With Polyethylene Glycol 3350 (Miralax®) is as Effective and Safe as Three-Day Preparation for Colonoscopy in Children
- ClinicalTrials.gov ID
- NCT02174497
- Acronym / sponsor ID
- OMB No 0925-0586
- Conditions
- Bowel Preparation, Pediatric Colonoscopy
- Keywords
- Pediatric Colonoscopy, Bowel Preparation, Safety, Tolerability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- St. John Health System, MichiganUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 25 Jun 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.
This was a blinded study conducted on the efficacy and safety of a one-day versus a three-day bowel preparation in a pediatric population. Limited data is available in this regard, and this study supports the use of a one-day bowel preparation, as this is both safe and effective.
Detailed description
Colonoscopy in children and young adults is performed by gastroenterologists for a variety of indications, including but not limited to evaluation of rectal bleeding, chronic diarrhea, family history of polyposis syndromes and surveillance for colon cancer in patients with inflammatory bowel disease. A successful bowel preparation that enables clear visualization of the intestinal mucosa is essential to diagnose and treat the underlying pathology. Currently, gastroenterologists use a variety of colon cleansing preparations, but Polyethylene Glycol (PEG) 3350 given for three to four days appears to be standard. Though it is well tolerated, safe and effective the duration of preparation may cause disruption to the routine and missed school days. To date, there is limited data that shows efficacy of a shorter duration of bowel preparation with PEG. This study aims to compare the efficacy and safety of a one-day preparation with that of a three-day preparation with PEG 3350 as preparation for colonoscopy in children and young adults.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | –Three day Bowel Preparation |
| Study Arm | – | –One day Bowel Preparation |
Who may qualify
- Ages
- 2 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Children between 2 and 21 years of age undergoing elective colonoscopy were enrolled into the study.
Key inclusion criteria (1 listed)
- Pediatric Patients referred for an outpatient colonoscopy
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Safety of a one day versus a three day colonoscopy preparation in a pediatric population
Time frame: 02/08-06/10 (28 months)
The Safety of the different preparations was documented by monitoring serum electrolytes before and after the preparation.
1 secondary outcome
Tolerability of a one day versus a three day colonoscopy preparation in a pediatric population
Time frame: 02/08-06/10 (28 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 25 Jun 2014.
- Derived from this study: PubMed 25223547Sorser SA, Konanki V, Hursh A, Hagglund K, Lyons H. 1-day bowel preparation with polyethylene glycol 3350 is as effective and safe as a 3-day preparation for colonoscopy in children. BMC Res Notes. 2014 Sep 15;7:648. doi: 10.1186/1756-0500-7-648.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bowel Preparation and Pediatric Colonoscopy, run by St. John Health System, Michigan 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 1 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 25 Jun 2014. 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?
Safety of a one day versus a three day colonoscopy preparation in a pediatric population (time frame: 02/08-06/10 (28 months)). 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 NCT02174497, 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 25 Jun 2014.