The purpose of the study is to evaluate the efficacy and safety of bisacodyl combined with escalating doses of lactulose to be used as a preparation for colonoscopy.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
32
15 mg of bisacodyl, plus 30 grams crystalline lactulose x 3 doses
15 mg of bisacodyl, plus 45 grams crystalline lactulose x 3 doses
15 mg of bisacodyl, plus 60 grams crystalline lactulose x 3 doses
ClinSearch, LLC
Chattanooga, Tennessee, United States
Efficacy of Bisacodyl and Lactulose as a Preparation for Colonoscopy.
Efficacy assessed by the physician's determination of the cleanliness of the colon using the Boston Bowel Preparation Scale (BBPS). 9 is the maximum score, representing an fully cleansed colon; 0 is the minimal score, representing a colon with no cleaning.
Time frame: 10-14 hours post last consumption
Safety of Bisacodyl and Lactulose as a Bowel evacuant_AE Incidence
Safety determined by the incidence of treatment emergent adverse events.
Time frame: 1 day post last consumption
Safety of Bisacodyl and Lactulose as a Bowel evacuant_AE Severity
Safety determined by the severity of treatment emergent adverse events.
Time frame: 1 day post last consumption
Tolerability of and Preference for Bisacodyl and Lactulose as a Bowel Evacuant
Tolerability assessed by a patient questionnaire. Overall tolerability as given by Visual Analog Scale (VAS): 100 represents maximally tolerable; 0 represents minimally tolerable
Time frame: 1 day post last consumption
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