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

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

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 Overview

• Status: Completed
• Conditions: Postoperative Ileus
• Intervention / Treatment: Drug: Daikenchuto (TU-100); Drug: Daikenchuto (TU-100); Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic, Rochester Methodist CRU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Tsumura USA
• Collaborators: Cato Research
• Investigators: Principal Investigator: Michael Camilleri, MD, Mayo Clinic, Rochester Methodist CRU

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): January 1, 2010

Study Registration Dates

• First Submitted: March 26, 2009
• First Submitted That Met QC Criteria: March 26, 2009
• First Posted (Estimate): March 30, 2009

Study Record Updates

• Last Update Posted (Estimate): January 14, 2013
• Last Update Submitted That Met QC Criteria: January 8, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: Gastric emptying; Postoperative Ileus; Colonic transit; Small bowel transit; Whole gut transit
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Obstruction; Ileus
• Other Study ID Numbers: TU100CPT1