Ability of Mayo Clinic HPLC Method to Measure Fecal Bile Acids to Demonstrate Response to Colesevelam in Patients With Diarrhea Predominant Irritable Bowel Syndrome

Location:

Rochester, Minn.

Trial status:

Open for Enrollment

Why is this study being done?

The investigators' hypothesis is that therapy with Colesevelam, reduces fecal bile acid excretion in patients with IBS-diarrhea with prior evidence of increased fecal 48 hour total bile acid excretion. The investigators aim to study the ability of the HPLC assay for fecal bile acids to demonstrate responsiveness after treatment with Colesevelam.

Who is eligible to participate?

Patients with IBS-diarrhea with prior evidence of increased fecal 48 hour total bile acid and increased fasting serum 7alphaC4 who meet the following: INCLUSION CRITERIA - BDQ- IBS symptoms: Positive by Rome lll criteria - HAD: No restrictions on Hospital Anxiety/Depression score. - Age: 18-65 years - Gender: Men or women. Women of childbearing potential will have a negative pregnancy test before initiation of medication. EXCLUSION CRITERIA - Use of drugs or agents within the past 1 week or planned use in the subsequent 2 weeks during the study period (Birth control pill, estrogen replacement therapy, and thyroxine replacement are permissible exceptions): - Agents that alter GI transit including opioids, narcotics, anticholinergics, tricyclic antidepressants, SNRI antidepressants. - Analgesic drugs including opiates, NSAID, COX 2 inhibitors - Intake of medication that could interfere with the interpretation of the study. - Female subjects who are pregnant or breast-feeding. Females must be either surgically sterilized, postmenopausal (>12 months since last menses), or, if of childbearing potential, using reliable methods of contraception as determined by the physician. - Abdominal surgery (except Appendectomy) - Patients with known chronic liver disease or history of elevated AST/ALT 2.0 X upper limit of normal. - BA synthesis and possible false positive or negative fecal bile acid or serum 7alphaC4 result. If there is no AST or ALT values in the medical record, the study physicians will determine if the tests need to be run.

Last updated:

8/21/2014

NCT ID:

NCT02111603

IRB Number:

14-000384