Cheno Effect on Transit in Health and IBS-C

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Mayo Clinic
• Collaborators: National Center for Research Resources (NCRR); National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Treatments: Chenodeoxycholic Acid

Criteria

Inclusion Criteria:

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 Criteria:

• 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