Cheno Effect on Transit in Health and IBS-C

Completed · Phase 2 · Has a placebo group

Conditions studied: Constipation-predominant Irritable Bowel Syndrome

In brief

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).

Key facts

Study ID

NCT00912301

Run by

Mayo Clinic

People needed

36

Starts

2009-04-01

Expected to finish

2009-12-01

Last updated by the study team

2012-07-02

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy volunteers:
• Age (yr) 18-65
• Gender (F:M)3.5 :1
• Bowel Disease Questionnaire (BDQ) - IBS symptoms negative by Rome III criteria
• Hospital Anxiety/Depression score <8
• IBS patients:
• Age (yr) 18-65
• Gender (F:M) 5 :1
• BDQ - IBS symptoms: positive by Rome III criteria
• Hospital Anxiety/Depression score: No restrictions

You may not qualify if…

• Abdominal surgery (except appendectomy or cholecystectomy)
• GI medications during the 48h prior to transit measurement
• Aspartate/Alanine transaminases >2 X Upper Limit of Normal (ULN)
• Other Medications except stable doses of estrogen, thyroid, low dose antidepressants of the dopaminergic or serotonergic class

Where it is running

• Mayo Clinic — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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