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OpenTrials
Completed

NCT Number: NCT01719653

A Comparison of 5 Low Volume Bowel Preparations

The purpose of this investigation is to compare 3 versions of MiraLAX/Gatorade, MoviPrep and SUPREP to see which preparation cleanses the colon best and which preparation is best tolerated.

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Key information

Conditions

Bowel Preparation for Colonoscopy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Gastroenterology Services

Downers Grove, Illinois, 60515, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients at least 18 years old planning to undergo an elective colonoscopy will be eligible for inclusion in our study. We would prefer to exclude as few groups as possible since in clinical practice these less well studied groups often need a colonoscopy and will need to have a colonoscopy preparation.

Exclusion criteria

  • Patients who are allergic (this is very rare) or intolerant to any of the study drugs.
  • Patients who are pregnant.
  • Patients who required multiple day colon preparations (2 days prior and 1 day prior) in the past will be excluded.
  • Patients with ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis or toxic megacolon would not be considered elective colonoscopies and are excluded.
  • Patients with known renal disease (baseline creatinine greater than 1.50 mg/dl) will need to be excluded due to the magnesium in SUPREP which is contraindicated in patients with significant renal disease.

Treatment and study plan

MIRALAX

Drug

MiraLAX consumed as described in each arm.

Other names: PEG-3350

Gatorade

Other

Gatorade consumed as described in each arm.

MoviPrep

Drug

MoviPrep consumed as described in each arm.

SUPREP

Drug

SUPREP consumed as described in each arm.

Primary outcomes

  1. Chicago Bowel Preparation Scale

    Time frame: At completion of colonoscopy - day 1

    The quality of the colon preparation as graded using our new Chicago Bowel Preparation Scale (BPS) (Adventist Midwest Region Institutional Review Board, AMH 2010-01-80; ClinicalTrials.gov NCT01063049). Chicago BPS total score is ranges from 0 (very poor) to 36 (outstanding). Modified Chicago BPS total score is ranges from 0 (very poor) to 33 (outstanding). Chicago BPS Fluid score is ranges from 0 (dry) to 3 (wet).

Secondary outcomes

  1. Boston Bowel Preparation Scale

    Time frame: At completion of colonoscopy - day 1

    The quality of the colon preparation as graded using Boston Bowel Preparation total scores is range from 0 (very poor) to 9 (outstanding).

  2. Adequate/Inadequate Scale

    Time frame: At completion of colonoscopy - day 1

    The cleanliness of the colon as rated by the gastroenterologist using an adequate/inadequate scale where an adequate preparation is defined as being able to see at least 95% of the mucosa of the colon after washing and suctioning; otherwise, the preparation is rated as inadequate.

Sponsors and collaborators

Lead sponsor

Gastroenterology Services, Ltd.

Other

Registry information

Official study title

A Randomized Comparison of Five Low Volume Bowel Preparations for Colonoscopy

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Nov 1, 2012
Registry last updated
Mar 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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