Trial to Understand Efficacy of Colesevelam in Diarrhea Predominant IBS Patients With Bile Acid Malabsorption
Condition: Chronic Diarrhea; Irritable Bowel Syndrome With Diarrhea; Bile Acid Malabsorption
MeSH terms: Irritable Bowel Syndrome; Malabsorption Syndromes; Diarrhea
Intervention: Colesevelam; Placebo
Intervention description: Colesevelam (Welchol) is approved by the Food and Drug Administration (FDA) for the treatment of high blood cholesterol levels and to treat type 2 diabetes however, Colesevelam is not approved for the use proposed in this study and is considered investigational.; A placebo looks exactly like the study drug, but it contains no active ingredient. This is used to learn if the effects seen in research participants are truly from the study drug.
Intervention MeSH terms: Colesevelam Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is the third specific aim of a program on IBS-D with increased fecal bile acid excretion.
Masking: Triple (Participant, Care Provider, Investigator)
Masking description: 30 subjects with irritable bowel syndrome and diarrhea and bile acid malabsorption will be randomized into 15 people per group in 4-week double-blind, parallel-group trial to Colesevelam or placebo.
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

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.
    

Eligibility 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