Status:
COMPLETED
Cheno Effect on Transit in Health and IBS-C
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Center for Research Resources (NCRR)
Conditions:
Constipation-predominant Irritable Bowel Syndrome
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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 S...
Detailed Description
Hypothesis: A hydrophobic di-alpha hydroxy bile salt, sodium chenodeoxycholate (CDC), delivered in a delayed release capsule to the ileocolonic region of the colon induces acceleration of colonic tran...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00912301
Start Date
April 1 2009
End Date
December 1 2009
Last Update
July 2 2012
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905