Clinical trial NCT00871325: Effect of TU-100 on Gastrointestinal and Colonic Transit in Humans
Official title: Effect of Gastrointestinal Nerve Modulation With DAIKENCHUTO (TU-100) on Gastrointestinal and Colonic Transit in Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Postoperative Ileus
Keywords: Gastric emptying
Small bowel transit
Colonic transit
Whole gut transit
Postoperative Ileus
Lead sponsor: Tsumura USA
Sponsor class: INDUSTRY
Collaborators: name: Cato Research
First posted: 2009-03-30
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Gastric emptying of solid
timeFrame: 1 hr, 2 hrs, 3 hrs, 4 hrs, 5 hrs, 6 hrs, 8 hrs, 24 hrs, 48 hrs
measure: Colonic geometric center at 24 hours
timeFrame: 4 hrs, 8 hrs, and 24 hrs
measure: Ascending colon emptying
timeFrame: 1 hr, 2 hrs, 3 hrs, 4 hrs, 5 hrs, 6 hrs, 8 hrs, 24 hrs
Secondary outcomes:
measure: Colonic geometric center at 4 hours and 48 hours
timeFrame: 1 hr, 2 hrs, 3 hrs, 4 hrs, 5 hrs, 6 hrs, 8 hrs, 24 hrs, 48 hrs
measure: Colonic filling at 6 hours
timeFrame: 1 hr, 2 hrs, 3 hrs, 4 hrs, 5 hrs, 6 hrs
measure: Stool frequency
timeFrame: Day 1, Day 2, Day 3, Day 4, Day 5
measure: Stool consistency
timeFrame: Day 1, Day 2, Day 3, Day 4, Day 5
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic, Rochester Methodist CRU
state: Minnesota
Study officials:
affiliation: Mayo Clinic, Rochester Methodist CRU
name: Michael Camilleri, MD
role: PRINCIPAL_INVESTIGATOR
References: