ColonoscopyNCT01518790
Short Course, Single-dose PEG 3350 for Colonoscopy Prep in Children
A study testing polyethylene glycol 3350 in people with Colonoscopy, run by Walter Reed National Military Medical Center at 1 site in United States.
Trial summary
The investigators propose to conduct a prospective study of a widely used bowel preparation regimen (polyethylene glycol 3350 + a sports drink) on pediatric patients who undergo a colonoscopy performed by the pediatric gastroenterology service at WRAMC/WRNMMC between 1 Sep 2010 and 31 Dec 2011. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Colonoscopy
- What is being tested?
- polyethylene glycol 3350
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Aug 2011
- 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 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Male and female DEERS-eligible dependent military health care beneficiaries age 8 to 18 years old evaluated by Pediatric Gastroenterology service at WRAMC and are scheduled to undergo a colonoscopy between 1 Sep 2010 - 31 Dec 2011 and do not meet exclusion criteria.
Who cannot join
- Age less than 8 years or greater than 18 at time of procedure
- Colonic surgery including hemicolectomy, colectomy, ileostomy, or multiple abdominal surgeries.
- Oral aversion or other feeding disorder.
- Inability to drink large amount of liquids.
- Aspiration risk.
- Renal disease or pre-cleanout electrolytes outside normal range.
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- Significant cardiovascular disease.
- Allergy to food coloring or polyethylene glycol 3350.
- Inpatient or emergency colonoscopy.
- Current nasogastric tube in place.
- Known Pregnancy. Urine pregnancy test will only be completed on day of colonoscopy for all females age 14 and older per current standard anesthesia protocols. There have been no known reported animal or human studies that report the fetal effects of using polyethylene glycol. Per FDA, it is labeled as a category C drug in pregnancy. However, two studies , have reported successful treatment of constipation during pregnancy using polyethylene glycol solutions and did not find any significant effects or safety issues
Trial locations and contacts
1 site in 1 country.
United States1 site
Walter Reed National Military Medical Center
Bethesda, Maryland, 20814
About this study
Official title: Evaluation of Short Course, Single-dose Polyethylene Glycol (PEG) 3350 Regimen for Colonoscopy Bowel Preparation in Children
The investigators propose to conduct a prospective study of a widely used bowel preparation regimen (polyethylene glycol 3350 + a sports drink) on pediatric patients who undergo a colonoscopy performed by the pediatric gastroenterology service at WRAMC/WRNMMC between 1 Sep 2010 and 31 Dec 2011. This study will involve the following: determine efficacy of the cleanout, assess tolerability and acceptance of the regimen, determine an appropriate duration to complete the regimen and assess for any electrolyte changes or side effects.
Read the detailed description
Purpose: It is hoped that by determining acceptability, safety and efficacy of this widely used short course, single-dose bowel preparation regimen, pediatric gastroenterologist can have a standardized bowel preparation for colonoscopy that will be acceptable to pediatric patients and their parents.
Research Design: This study is a prospective medication trial. It will utilize laboratory data to detect any electrolyte changes, a patient questionnaire to assess an acceptable duration, tolerance and side effects of the regimen. Efficacy of the cleanout will be assessed using a published standardized bowel preparation scale by the endoscopist at the completion of the colonoscopy.
Methodology /Technical Approach (including the number of subjects to be studied.): We estimate that 50 patients aged 8-18 years old military dependents who are undergoing a colonoscopy by the Pediatric Gastroenterology service at WRAMC/WRNMMC will be enrolled in the study between 1 Sep 2010 and 31 Dec 2011.
- Conditions
- Colonoscopy
- Being tested
- polyethylene glycol 3350
- Keywords
- PEG 3350, boston bowel preparation scale, colonoscopy cleanout, bowel preparation, miralax, gatorade, cleanout efficacy, Focus of study is efficacy of PEG 3350 cleanout for improving diagnostic yield of colonoscopy.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
polyethylene glycol 3350Drug
Also called Miralax
PEG 3350 (238 grams) mixed with 1.9 L (64 oz) of Gatorade, given in 8 oz increments every 15-30 minutes until complete starting at 18:00 on day prior to colonoscopy (max time to completion 6 hours).
| Study group | Role | What they receive |
|---|---|---|
| Polyethylene glycol 3350 | Experimental | Not described Receives: Drug: polyethylene glycol 3350 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of Cleanout
Efficacy of cleanout utilizing Boston bowel preparation scale, completed by endoscopy fellow and staff at the end of the colonoscopy done within 10-18 hours after completion of the cleanout.
Measured: At the end of the colonoscopy within 10-18 hours of completing the cleanout
Secondary outcomes (2)
Electrolyte changes assessing basic metabolic profiles pre/post cleanout
BMP will be obtain within 30 days of cleanout and on the day of the colonoscopy at the time of IV insertion for anesthesia.
Measured: 30 days prior to 1 day after cleanout
Patient/parent satisfaction/tolerability/side effects utilizing questionnaire
Parents or patient fill out questionnaire on day of the colonoscopy
Measured: 1 day after cleanout
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2012 (estimated)
- Study startSep 2010
- Primary completionAug 2011
- Study completionAug 2011
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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Walter Reed National Military Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Mazen I Abbas, DO, MPH, Principal investigator, Walter Reed National Military Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01518790
- Sponsor's protocol ID
- 353750
- Status last verified
- Feb 2016
- First submitted
- 13 Jan 2012
- Last updated
- 10 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Abbas MI, Nylund CM, Bruch CJ, Nazareno LG, Rogers PL. Prospective evaluation of 1-day polyethylene glycol-3350 bowel preparation regimen in children. J Pediatr Gastroenterol Nutr. 2013 Feb;56(2):220-4. doi: 10.1097/MPG.0b013e31826630fc.
PubMed 22744195
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Short Course, Single-dose Polyethylene Glycol (PEG) 3350 Regimen for Colonoscopy Bowel Preparation in Children
- ClinicalTrials.gov ID
- NCT01518790
- Acronym / sponsor ID
- 353750
- Conditions
- Colonoscopy
- Keywords
- PEG 3350, boston bowel preparation scale, colonoscopy cleanout, bowel preparation, miralax, gatorade, cleanout efficacy, Focus of study is efficacy of PEG 3350 cleanout for improving diagnostic yield of colonoscopy.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Walter Reed National Military Medical CenterUS federal agency
- Study start
- Sep 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 26 Jan 2012 (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 investigators propose to conduct a prospective study of a widely used bowel preparation regimen (polyethylene glycol 3350 + a sports drink) on pediatric patients who undergo a colonoscopy performed by the pediatric gastroenterology service at WRAMC/WRNMMC between 1 Sep 2010 and 31 Dec 2011. This study will involve the following: determine efficacy of the cleanout, assess tolerability and acceptance of the regimen, determine an appropriate duration to complete the regimen and assess for any electrolyte changes or side effects.
Detailed description
Purpose: It is hoped that by determining acceptability, safety and efficacy of this widely used short course, single-dose bowel preparation regimen, pediatric gastroenterologist can have a standardized bowel preparation for colonoscopy that will be acceptable to pediatric patients and their parents.
Research Design: This study is a prospective medication trial. It will utilize laboratory data to detect any electrolyte changes, a patient questionnaire to assess an acceptable duration, tolerance and side effects of the regimen. Efficacy of the cleanout will be assessed using a published standardized bowel preparation scale by the endoscopist at the completion of the colonoscopy.
Methodology /Technical Approach (including the number of subjects to be studied.): We estimate that 50 patients aged 8-18 years old military dependents who are undergoing a colonoscopy by the Pediatric Gastroenterology service at WRAMC/WRNMMC will be enrolled in the study between 1 Sep 2010 and 31 Dec 2011.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Polyethylene glycol 3350 | Experimental | Drug: polyethylene glycol 3350 |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Male and female DEERS-eligible dependent military health care beneficiaries age 8 to 18 years old evaluated by Pediatric Gastroenterology service at WRAMC and are scheduled to undergo a colonoscopy between 1 Sep 2010 - 31 Dec 2011 and do not meet exclusion criteria.
Key exclusion criteria (11 listed)
- Age less than 8 years or greater than 18 at time of procedure
- Colonic surgery including hemicolectomy, colectomy, ileostomy, or multiple abdominal surgeries.
- Oral aversion or other feeding disorder.
- Inability to drink large amount of liquids.
- Aspiration risk.
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 |
|---|---|---|
| polyethylene glycol 3350Also: MiralaxPEG 3350 (238 grams) mixed with 1.9 L (64 oz) of Gatorade, given in 8 oz increments every 15-30 minutes until complete starting at 18:00 on day prior to colonoscopy (max time to completion 6 hours). | Drug | Polyethylene glycol 3350 |
Primary outcome
Efficacy of Cleanout
Time frame: At the end of the colonoscopy within 10-18 hours of completing the cleanout
Efficacy of cleanout utilizing Boston bowel preparation scale, completed by endoscopy fellow and staff at the end of the colonoscopy done within 10-18 hours after completion of the cleanout.
2 secondary outcomes
Electrolyte changes assessing basic metabolic profiles pre/post cleanout
Time frame: 30 days prior to 1 day after cleanout
Patient/parent satisfaction/tolerability/side effects utilizing questionnaire
Time frame: 1 day after cleanout
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 10 Feb 2016.
- Derived from this study: PubMed 22744195Abbas MI, Nylund CM, Bruch CJ, Nazareno LG, Rogers PL. Prospective evaluation of 1-day polyethylene glycol-3350 bowel preparation regimen in children. J Pediatr Gastroenterol Nutr. 2013 Feb;56(2):220-4. doi: 10.1097/MPG.0b013e31826630fc.
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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.
Mazen I Abbas, DO, MPH principal investigator
Walter Reed National Military Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing polyethylene glycol 3350 in people with Colonoscopy, run by Walter Reed National Military Medical Center 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 11 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 10 Feb 2016. 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?
Efficacy of Cleanout (time frame: At the end of the colonoscopy within 10-18 hours of completing the cleanout). 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 NCT01518790, 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 10 Feb 2016; AzTrials last refreshed its copy on 29 Oct 2026.