Effect of TU-100 on Gastrointestinal and Colonic Transit in Humans

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Gastrointestinal Nerve Modulation With DAIKENCHUTO (TU-100) on Gastrointestinal and Colonic Transit in Humans

Conditions
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Postoperative Ileus

Intervention / Treatment
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* Drug: Daikenchuto (TU-100)
* Drug: Daikenchuto (TU-100)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is willing and able to provide written informed consent Males and non-pregnant, non-breastfeeding females; Subject is willing to undergo multiple radionuclide scans Subject BMI is between 18 and 35 kg/m2 Subject has a negative urine drug screen Subject has screening laboratory values that are within normal range for the analyzing laboratory Exclusion Criteria: Structural or metabolic diseases/conditions that affect the gastrointestinal system, or functional gastrointestinal disorders. Unable to withdraw medications 48 hours prior to the study: Alter GI transit including laxatives, magnesium or aluminum-containing antacids, prokinetics, erythromycin, narcotics, anticholinergics, tricyclic antidepressants, SSRI and newer antidepressants. Analgesic drugs including opiates, NSAID, COX 2 inhibitors GABAergic agents Benzodiazepines NOTE: Low stable doses of thyroid replacement, estrogen replacement, low dose aspirin for cardioprotection and birth control pills or depot injections are permissible. Female subjects who are pregnant or breast feeding. Clinical evidence (including physical exam, hemoglobin level and review of the medical history) of significant cardiovascular, respiratory, renal, hepatic, pulmonary, gastrointestinal, hematological, neurological, psychiatric, or other disease that interfere with the objectives of the study. History of allergic reactions to ginseng, ginger, and Sichuan pepper. History of lactose intolerance. Subjects who are considered by the investigator to be alcoholics not in remission or known substance abusers. Subjects who have participated in another clinical study within the past 30 days.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Daikenchuto (TU-100) 7.5g/day<br>Daikenchuto (TU-100) 2.5g TID (7.5g/day) | Drug: Daikenchuto (TU-100)<br>* 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.<br>|
| Experimental: Daikenchuto (TU-100) 15g/day<br>Daikenchuto (TU-100) 5g TID (15g/day) | Drug: Daikenchuto (TU-100)<br>* 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.<br>|
| Placebo Comparator: Placebo<br>Placebo TID | Drug: Placebo<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastric emptying of solid |  | 1 hr, 2 hrs, 3 hrs, 4 hrs, 5 hrs, 6 hrs, 8 hrs, 24 hrs, 48 hrs | 
| Colonic geometric center at 24 hours |  | 4 hrs, 8 hrs, and 24 hrs | 
| Ascending colon emptying |  | 1 hr, 2 hrs, 3 hrs, 4 hrs, 5 hrs, 6 hrs, 8 hrs, 24 hrs | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Colonic geometric center at 4 hours and 48 hours |  | 1 hr, 2 hrs, 3 hrs, 4 hrs, 5 hrs, 6 hrs, 8 hrs, 24 hrs, 48 hrs | 
| Colonic filling at 6 hours |  | 1 hr, 2 hrs, 3 hrs, 4 hrs, 5 hrs, 6 hrs | 
| Stool frequency |  | Day 1, Day 2, Day 3, Day 4, Day 5 | 
| Stool consistency |  | Day 1, Day 2, Day 3, Day 4, Day 5 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastric emptying, Small bowel transit, Colonic transit, Whole gut transit, Postoperative Ileus