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Cheno Effect on Transit in Health and IBS-C

NCT00912301 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2012-07-02

Study results available
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Summary

The study hypothesis is that the naturally occurring bile acid, chenodeoxycholic acid, induces acceleration of colonic transit in health and in patients with constipation-predominant Irritable Bowel Syndrome (IBS-C).

Conditions

  • Constipation-predominant Irritable Bowel Syndrome

Interventions

DRUG

Sodium chenodeoxycholate (NaCDC)

500 or 1000 milligrams NaCDC per day each for a period of 4 days

OTHER

Placebo

Placebo capsules with identical appearance to the study drug were prepared by the Mayo Clinic research pharmacy.

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • National Center for Research Resources (NCRR)

    collaborator NIH

  • Mayo Clinic

    lead OTHER

Principal Investigators

  • Michael L. Camilleri, M.D. · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2009-11-30
Completion
2009-12-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00912301 on ClinicalTrials.gov