Trial to Understand Efficacy of Colesevelam in Diarrhea Predominant IBS Patients With Bile Acid Malabsorption
Trial to Understand Efficacy of Colesevelam in Diarrhea Predominant IBS Patients With Bile Acid Malabsorption
To compare with a randomized trial (n=15 per treatment group), effects of colesevelam and
 placebo treatment, on colonic transit, bowel functions, permeability and tight junction
 expression in rectosigmoid mucosa of IBS-D with Bile Acid Malabsorption.
Compare the effects of Colesevelam versus the placebo on diabetic subjects with chronic
 diarrhea. In this study, diabetic subjects will get either the Colesevelam or the placebo,
 not both.

 The plan is to have about 30 subjects complete this study at Mayo Clinic.
Inclusion Criteria:

 -  Females and males age 18 -75.

 -  An IBS diagnosis based on the Rome III criteria for at least 3 months, with onset at
 least 6 months previously, of recurrent abdominal pain or discomfort.

 -  Biomarkers serum alpha C4 ≥ 40 ng/mL or FGF19 ≤ 80 pg/mL or fecal bile acid >2000
 micromoles/48h

 Exclusion Criteria:

 -  IBS patients with known clinically-relevant inflammation.

 -  IBS patient with known bleeding diathesis

 -  History of abdominal surgery

 Patients participating will not take any of the following disallowed medications for at
 least 7 days prior to and during the remainder of the study:

 -  Any treatment specifically taken for IBS-D, including loperamide, cholestyramine,
 alosetron

 -  Drugs with a known pharmacological activity at 5-HT4, 5-HT2b or 5-HT3 receptors

 -  All narcotics

 -  Anti-cholinergic agents

 -  Tramadol

 -  Oral anticoagulants

 -  Antimuscarinics

 -  Peppermint oil

 -  Systemic antibiotics, as well as antibiotics directed at colonic flora such as
 rifaximin and metronidazole

 Gastrointestinal preparations:

 -  Anti-nausea agents

 -  Osmotic laxative agents

 -  Prokinetic agents

 -  5-HT3 antagonists