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The Efficacy Side Effects and the Tolerance of Polyethylene Glycol 3350 as a Bowel Prep in Children

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ClinicalTrials.gov Identifier: NCT01164410
Recruitment Status : Completed
First Posted : July 16, 2010
Last Update Posted : October 24, 2017
Sponsor:
Information provided by (Responsible Party):
The Cleveland Clinic

Brief Summary:

Bowel preparation solutions containing Polyethylene Glycol is a commonly used preparation of the colon for colonoscopy in children. However young children and adolescents often subject to the volume and taste of liquid that must be consumed for an adequate preparation. Currently almost all of our patients experience some difficulty with completing the colyte preparation and approximately 10-20% is unable to achieve adequate cleansing due to inability to drink the solution. The standard colyte solution is salty and often impedes children from drinking the required amount of colyte preparation for adequate colon cleansing. Miralax has been used at a dose of 1.5gm/kg/day to a maximum of 102 gms /day as four day prep Four day bowel prep can be extremely frustrating for the parents and the patients. This may result in low patient acceptance, limiting compliance leading to inadequate colonoscopy. Decreasing the duration of the prep may increase the compliance and provide better colon visualization.

Hence a Cross sectional study looking at the safety,efficacy,tolerability of PEG 3350 mixed in Gatorade G(TM) as a bowel prep in children needs to be conducted. Consent will be obtained from parents and assent will be obtained from patients. Previous laboratory tests for each patient will be reviewed. All patients in the study will be required to consume MiralaxTM/Gatorade GTM the day prior to their procedure. The patients will be given written instructions as to how to much solution to take and how to prepare and consume the solution. The patient shall be maintained on a clear liquid diet the day prior to the procedure. Once patients arrive for the colonoscopy they will be asked to complete a questionnaire regarding their bowel preparation. Prior to the administration of IV fluids, 1ml of blood will be obtained a basic metabolic panel. The patient will then undergo a colonoscopy by routine procedure and technique. The endoscopist will complete a questionnaire when done with the colonoscopy to rate the cleanliness of the colon.

We propose that MiralaxTM combined with Gatorade GTM given the day prior to colonoscopy is a safe, tolerable and efficacious cleansing regimen for colonoscopy in children.


Condition or disease
Colonoscopy

Detailed Description:

Inclusion Criteria:

  1. Patients five years old or older that present to the pediatric GI clinic and are capable of taking oral liquids and have been scheduled for a colonoscopy.
  2. Patients who are able to communicate their discomfort and preferences.

Exclusion Criteria:

  1. Patients that are neurologically compromised
  2. Patients in need of emergent colonoscopy
  3. Patients with known metabolic, endocrine, renal or cardiac conditions.
  4. Presence of pre-existing ostomy, short bowel syndrome, gastric retention, intestinal obstruction or swallowing difficulties.
  5. Patients with known electrolyte abnormalities.
  6. Patients who are allergic to PEG-3350.
  7. Patients that are known to be pregnant.
  8. Patients with known fructose intolerance.
  9. Patient younger than five years old.

Study Type : Observational
Actual Enrollment : 45 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Efficacy Side Effects and the Tolerance of Polyethylene Glycol 3350 as a Bowel Prep in Children
Study Start Date : August 2009
Actual Primary Completion Date : April 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy
U.S. FDA Resources

Group/Cohort
Pediatric Colonoscopy
Patients undergoing colonoscopy in the Department of Pediatric Gastroenterology at the Cleveland Clinic Children's Hospital in Cleveland, Ohio.



Primary Outcome Measures :
  1. MiralaxTM combined with Gatorade GTM given the day prior to colonoscopy is a safe, tolerable and efficacious cleansing regimen for colonoscopy in children. [ Time Frame: Immediate ]


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Ages Eligible for Study:   5 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Forty-five patients undergoing colonoscopy in the Department of Pediatric Gastroenterology at the Cleveland Clinic Children's Hospital in Cleveland, Ohio.
Criteria

Inclusion Criteria:

  • Patients five years old or older that present to the pediatric GI clinic and are capable of taking oral liquids and have been scheduled for a colonoscopy.
  • Patients who are able to communicate their discomfort and preferences.

Exclusion Criteria:

  • Patients that are neurologically compromised
  • Patients in need of emergent colonoscopy
  • Patients with known metabolic, endocrine, renal or cardiac conditions.
  • Presence of pre-existing ostomy, short bowel syndrome, gastric retention, intestinal obstruction or swallowing difficulties.
  • Patients with known electrolyte abnormalities.
  • Patients who are allergic to PEG-3350.
  • Patients that are known to be pregnant.
  • Patients with known fructose intolerance.
  • Patient younger than five years old.

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 ClinicalTrials.gov identifier (NCT number): NCT01164410


Locations
United States, Ohio
Cleveland Clinic Childrens Hospital
Cleveland, Ohio, United States, 44124
Sponsors and Collaborators
The Cleveland Clinic

Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01164410     History of Changes
Other Study ID Numbers: CCF 09-378
First Posted: July 16, 2010    Key Record Dates
Last Update Posted: October 24, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Polyethylene glycol 3350
Laxatives
Gastrointestinal Agents