Status:
COMPLETED
Trial to Understand Efficacy of Colesevelam in Diarrhea Predominant IBS Patients With Bile Acid Malabsorption
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Chronic Diarrhea
Irritable Bowel Syndrome With Diarrhea
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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 rectosig...
Detailed Description
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 i...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 7 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2019
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03270085
Start Date
December 7 2017
End Date
May 31 2019
Last Update
April 27 2020
Active Locations (1)
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1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905