Trial to Understand Efficacy of Colesevelam in Diarrhea Predominant IBS Patients With Bile Acid Malabsorption

• Status: Completed
• Trial end date: 2019-05-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Treatments: Bile Acids and Salts; Colesevelam Hydrochloride

Criteria

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