A Comparison of 5 Low Volume Bowel Preparations

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized Comparison of Five Low Volume Bowel Preparations for Colonoscopy

Conditions
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Bowel Preparation for Colonoscopy

Intervention / Treatment
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* Drug: MiraLAX
* Other: Gatorade
* Drug: MoviPrep
* Drug: SUPREP


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: MiraLAX 306 g (Day-Prior)<br>MiraLAX 306 g and Gatorade 64 oz (1/2 gallon) consumed the day-prior to the colonoscopy as follows: Miralax 51 g at 12 noon; Gatorade 64 oz mixed with Miralax 255 g from about 6 PM to 9 PM | Drug: MiraLAX<br>* MiraLAX consumed as described in each arm.<br>* Other names: PEG-3350;Other: Gatorade<br>* Gatorade consumed as described in each arm.<br>|
| Experimental: MiraLAX 357 g (Day-Prior)<br>MiraLAX 357 g and Gatorade 64 oz (1/2 gallon) consumed the day-prior to the colonoscopy as follows: Miralax 68 g at 12 noon; Gatorade 64 oz mixed with Miralax 289 g from about 6 PM to 9 PM. | Drug: MiraLAX<br>* MiraLAX consumed as described in each arm.<br>* Other names: PEG-3350;Other: Gatorade<br>* Gatorade consumed as described in each arm.<br>|
| Experimental: MiraLAX 306 g (Split-Dose)<br>MiraLAX 306 g and Gatorade 64 oz (1/2 gallon) consumed as a split-dose as follows: Gatorade 32oz mixed with Miralax 153 g from about 6 PM to 8 PM the day prior to the colonoscopy; Gatorade 32oz mixed with Miralax 153 g from about 2-4 hours prior to the colonoscopy. | Drug: MiraLAX<br>* MiraLAX consumed as described in each arm.<br>* Other names: PEG-3350;Other: Gatorade<br>* Gatorade consumed as described in each arm.<br>|
| Active Comparator: MoviPrep (Split-Dose)<br>MoviPrep consumed as a split-dose as follows: MoviPrep 1 liter consumed from about 6 PM to 7 PM the day prior to the colonoscopy followed by 0.5 liter of clear liquids; MoviPrep 1 liter consumed from 3-4 hours prior to the colonoscopy followed by 0.5 liter of clear liquids. | Drug: MoviPrep<br>* MoviPrep consumed as described in each arm.<br>|
| Active Comparator: SUPREP (Split-Dose)<br>SUPREP consumed as a split-dose as follows: SUPREP 16 oz consumed from about 6 PM to 7 PM the day prior to the colonoscopy followed by 32 oz of clear liquids; SUPREP 16 oz consumed from 3-4 hours prior to the colonoscopy followed by 32 oz of clear liquids. | Drug: SUPREP<br>* SUPREP consumed as described in each arm.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chicago Bowel Preparation Scale | 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). | At completion of colonoscopy - day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Boston Bowel Preparation Scale | The quality of the colon preparation as graded using Boston Bowel Preparation total scores is range from 0 (very poor) to 9 (outstanding). | At completion of colonoscopy - day 1 | 
| Adequate/Inadequate Scale | 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. | At completion of colonoscopy - day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colonoscopy, Bowel Preparation, MiraLAX, Gatorade, PEG-3350, MoviPrep, SUPREP, Chicago Bowel Preparation Scale, Boston Bowel Preparation Scale