NCT01518790

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 13, 2012

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 26, 2012

Completed
Last Updated

February 10, 2016

Status Verified

February 1, 2016

Enrollment Period

11 months

First QC Date

January 13, 2012

Last Update Submit

February 9, 2016

Conditions

Colonoscopy

Keywords

PEG 3350boston bowel preparation scalecolonoscopy cleanoutbowel preparationmiralaxgatoradecleanout efficacyFocus of study is efficacy of PEG 3350 cleanout for improving diagnostic yield of colonoscopy.

Outcome Measures

Primary Outcomes (1)

  • 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.

    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

    30 days prior to 1 day after cleanout

  • Patient/parent satisfaction/tolerability/side effects utilizing questionnaire

    1 day after cleanout

Study Arms (1)

Polyethylene glycol 3350

EXPERIMENTAL
Drug: polyethylene glycol 3350

Interventions

polyethylene glycol 3350DRUG

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).

Also known as: Miralax
Polyethylene glycol 3350

Eligibility Criteria

Age8 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Walter Reed National Military Medical Center

Bethesda, Maryland, 20814, United States

Location

Related Publications (1)

  • 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.

    PMID: 22744195DERIVED

MeSH Terms

Interventions

polyethylene glycol 3350

Study Officials

  • Mazen I Abbas, DO, MPH

    Walter Reed National Military Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2012

First Posted

January 26, 2012

Study Start

September 1, 2010

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

February 10, 2016

Record last verified: 2016-02

Locations

US(1)