Short Course, Single-dose PEG 3350 for Colonoscopy Prep in Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01518790
Recruitment Status : Completed
First Posted : January 26, 2012
Last Update Posted : February 10, 2016
Information provided by (Responsible Party):
Walter Reed National Military Medical Center

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Colonoscopy Drug: polyethylene glycol 3350 Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of Short Course, Single-dose Polyethylene Glycol (PEG) 3350 Regimen for Colonoscopy Bowel Preparation in Children
Study Start Date : September 2010
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

Arm Intervention/treatment
Experimental: Polyethylene glycol 3350 Drug: polyethylene glycol 3350
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).
Other Name: Miralax

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Electrolyte changes assessing basic metabolic profiles pre/post cleanout [ Time Frame: 30 days prior to 1 day after 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.

  2. Patient/parent satisfaction/tolerability/side effects utilizing questionnaire [ Time Frame: 1 day after cleanout ]
    Parents or patient fill out questionnaire on day of the colonoscopy

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Ages Eligible for Study:   8 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01518790

United States, Maryland
Walter Reed National Military Medical Center
Bethesda, Maryland, United States, 20814
Sponsors and Collaborators
Walter Reed National Military Medical Center
Principal Investigator: Mazen I Abbas, DO, MPH Walter Reed National Military Medical Center

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Walter Reed National Military Medical Center Identifier: NCT01518790     History of Changes
Other Study ID Numbers: 353750
First Posted: January 26, 2012    Key Record Dates
Last Update Posted: February 10, 2016
Last Verified: February 2016

Keywords provided by Walter Reed National Military Medical Center:
PEG 3350
boston bowel preparation scale
colonoscopy cleanout
bowel preparation
cleanout efficacy
Focus of study is efficacy of PEG 3350 cleanout for improving diagnostic yield of colonoscopy.

Additional relevant MeSH terms:
Polyethylene glycol 3350
Gastrointestinal Agents