The purpose of this study is to compare the dose related effects of orally administered TU-100, a botanical agent that modulates gastrointestinal nerves, on gastrointestinal motility and colonic transit of solids.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
QUADRUPLE
Enrollment
60
Subjects will receive 2.5g TID (7.5g/day) of TU-100. Dosage form is a granule. Subject will take a daily dose divided three times a day for 5 days.
Subjects will receive 5g TID (15g/day) of TU-100. Dosage form is a granule. Subject will take a daily dose divided three times a day for 5 days.
Subjects will receive daily dose of TU-100 placebo. Dosage form is a granule. Subject will take a daily dose divided three times a day for 5 days.
Mayo Clinic, Rochester Methodist CRU
Rochester, Minnesota, United States
Gastric emptying of solid
Time frame: 1 hr, 2 hrs, 3 hrs, 4 hrs, 5 hrs, 6 hrs, 8 hrs, 24 hrs, 48 hrs
Colonic geometric center at 24 hours
Time frame: 4 hrs, 8 hrs, and 24 hrs
Ascending colon emptying
Time frame: 1 hr, 2 hrs, 3 hrs, 4 hrs, 5 hrs, 6 hrs, 8 hrs, 24 hrs
Colonic geometric center at 4 hours and 48 hours
Time frame: 1 hr, 2 hrs, 3 hrs, 4 hrs, 5 hrs, 6 hrs, 8 hrs, 24 hrs, 48 hrs
Colonic filling at 6 hours
Time frame: 1 hr, 2 hrs, 3 hrs, 4 hrs, 5 hrs, 6 hrs
Stool frequency
Time frame: Day 1, Day 2, Day 3, Day 4, Day 5
Stool consistency
Time frame: Day 1, Day 2, Day 3, Day 4, Day 5
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