The aim of the study is to evaluate the efficacy of the stimulant laxative Senokot-S® for the treatment of diabetic gastroparesis. Senokot-S, and its metabolites, are thought to produce peristalsis, drive intraluminal fluid and electrolyte shifts, and have an irritant effect on the gut mucosa. These complex physiologic mechanisms appear may sufficiently promote stomach emp-tying, and thereby reduce or eliminate the severity of gastroparesis symptoms. In this open label study, participants will be randomized into high and low dose groups to assess for ideal dosing and tolerability. It is the overall goal of this study to select the most promising dose-strength for the treatment of mild through severe gastroparesis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
2
Stimulant laxative
Aurora Health Care
Milwaukee, Wisconsin, United States
Modified Gastroparesis Cardinal Symptom Index-Daily Diary (mGCSI-DD)
mGCSI-DD uses 6-point Likert scale from 0 (none) to very severe (5)
Time frame: 28 days
Frequency of Use of Breakthrough Medication
Change in the frequency of use of breakthrough medication - daily diary
Time frame: 28 days
Frequency of Bowel Movements
Change in the frequency of bowel movements - daily diary
Time frame: 28 days
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