Conditions: Colonoscopy
Keywords: Efficacy of bowel cleansing Patient tolerability Amitiza Dulcolax Miralax Colonoscopy preparation Bowel preparation Screening colonoscopy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 425
Healthy volunteers: yes

Brief summary:
Miralax (PEG 3350) has been shown to be a safe and uncomplicated bowel preparation prior to colonoscopy in pediatric populations. This study seeks to confirm the efficacy of this bowel cleansing regimen in adults and to determine the benefit of adding a pretreatment medication to this bowel preparation. The tolerability of Miralax will hopefully improve patient satisfaction with colonoscopy and decrease their reluctance to be screened because of the uncomfortable taste and side effects of bowel preparation regimens.

Detailed description:

Arms:
arm 1: 106 patients randomized to Miralax plus Amitiza will take one 24mcg gelcap of Amitiza at noon the day prior to their colonoscopy. On the day prior to the colonoscopy, the patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy. arm 2: 107 patients randomized to Miralax plus Dulcolax will take two 5mg tablets of Dulcolax at noon the day prior to their colonoscopy. On the day prior to the colonoscopy, the patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy. arm 3: 106 patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy. arm 4: 106 patients will take 1 gallon of golytley (Polyethylene glycol) and drink 1/2 of the solution at 4 p.m. The remaining 1/2 of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy

Interventions: intervention 1: Miralax (PEG 3350) intervention 2: Amitiza (Lubiprostone) intervention 3: Dulcolax (Bisacodyl) intervention 4: Golytely (polyethylene glycol)
Intervention descriptions: intervention 1: Miralax 255gm bottle intervention 2: Amitiza 24mcg gelcap intervention 3: Bisacodyl 5mg tab x2 intervention 4: Golytely 1 gallon

Protocol document: