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

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.

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