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Effect of TU-100 on Gastrointestinal and Colonic Transit in Humans | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

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

NCT00871325•Tsumura USA

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

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Yes

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.
+3 more criteria

Locations (1)

Mayo Clinic, Rochester Methodist CRU

Rochester, Minnesota, United States

Key Dates

Start Date

June 1, 2009

Primary Completion Date

December 1, 2009

Completion Date

January 1, 2010

Last Updated

January 14, 2013

Enrollment

ACTUAL participants

Conditions

Postoperative Ileus

Interventions

Daikenchuto (TU-100)

DRUG

Daikenchuto (TU-100)

DRUG

Placebo

DRUG

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TERMINATEDNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 14, 2013Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Pyridostigmine Efficacy and Safety for Treatment of Ileus After Colorectal Surgery

The Effect of Coffee After Resection of Small Bowel

Use of Beetroot Juice to Protect Against Postoperative Ileus (POI) Following Colorectal Surgery: a Pilot Study.

Implementing a Low Fiber Diet vs. Regular Diet in Postoperative Colorectal Patients With Ileostomies

Ileus After Lumbar Spine Surgery

Subcutaneous Methylnaltrexone Versus Placebo for Postoperative Ileus Prevention