Gatorade/Miralax With or Without Bisacodyl Versus NuLytely for Colonoscopy Preparation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare Nulytely (or Trilyte) with a Gatorade and Miralax combination for cleaning out the colon before colonoscopy. A laxative pill called Bisacodyl may also be used with the Gatorade and Miralax to see if it helps with the clean out process. We are trying to find out if either of these methods is more acceptable to the patient and does a better job cleaning out the colon for a colonoscopy.

Official Title
-----------------
Gatorade/Miralax With or Without Bisacodyl vs NuLytely for Colonoscopy Preparation

Conditions
-----------------
Preparation for Colonoscopy

Intervention / Treatment
-----------------
* Drug: Gatorade/Miralax
* Drug: NuLytely
* Drug: Bisacodyl
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. Patients at least 18 years old planning to undergo an elective colonoscopy. Exclusion Criteria: Patients who are allergic or intolerant to any on the study drugs. Pregnant patients. Patients who required multiple day colon preparation in the past. Patients with ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis or toxic megacolon would not be considered elective colonoscopies and are excluded.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nulytely<br>Nulytely (or Trilyte) 128 oz (1 gallon) to be consumed from about 5 PM to 9 PM the night before the colonoscopy. | Drug: NuLytely<br>* Nulytely (or Trilyte) 128 oz (1 gallon) to be consumed from about 5 PM to 9 PM the night before the colonoscopy.<br>|
| Experimental: Gatorade/Miralax + Placebo<br>Gatorade 64 oz (1/2 gallon), Miralax 306 g and a placebo (two 0.4 mg folic acid pills) to be consumed the day before the colonoscopy as follows: Miralax 51 g and placebo at 12 noon. Gatorade 64 oz mixed with Miralax 255 g from about 5 PM to 9 PM. | Drug: Gatorade/Miralax<br>* Gatorade 64 oz (1/2 gallon), Miralax 306 g to be consumed the day before your colonoscopy as follows: Miralax 51 g at 12 noon. Gatorade 64 oz mixed with Miralax 255 g from about 5 PM to 9 PM.<br>Drug: Placebo<br>* Placebo (two 0.4 mg folic acid pills) to be consumed the day before the colonoscopy<br>|
| Experimental: Gatorade/Miralax + Bisacodyl<br>Gatorade 64 oz (1/2 gallon), Miralax 306 g and Bisacodyl 10 mg (two 5 mg pills) to be consumed the day before the colonoscopy as follows: Miralax 51 g and Bisacodyl 10 mg at 12 noon. Gatorade 64 oz mixed with Miralax 255 g from about 5 PM to 9 PM. | Drug: Gatorade/Miralax<br>* Gatorade 64 oz (1/2 gallon), Miralax 306 g to be consumed the day before your colonoscopy as follows: Miralax 51 g at 12 noon. Gatorade 64 oz mixed with Miralax 255 g from about 5 PM to 9 PM.<br>Drug: Bisacodyl<br>* Bisacodyl 10 mg (two 5 mg pills) to be consumed the day before the colonoscopy at 12 noon.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Quality of the Colon Preparation Will be Graded Using the Boston Bowel Preparation Scale | The Boston Bowel Preparation Scale measures cleanliness of the colon on a scale of 0 (very poor) to 9 (excellent). | After Colonoscopy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Ottawa Scale for Colonoscopy Preparation Will be Reported and Compared Among the 3 Groups to Allow for Comparisons to Some of the Older Literature | Ottawa scale measures colon cleanliness on a scale from 14 (very poor) to 0 (excellent). | After Colonoscopy |