Ability of Mayo Clinic High-performance Liquid Chromatography (HPLC) Method to Measure Fecal Bile Acids
Condition: Diarrhea Predominant Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome; Diarrhea
Intervention: Colesevelam
Intervention description: Subjects will receive 1875 mg of Colesevelam orally twice daily for 10 days
Intervention MeSH terms: Colesevelam Hydrochloride
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The investigators' hypothesis is that therapy with Colesevelam, reduces fecal bile acid
      excretion in patients with Irritable Bowel Syndrome (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.
    

Eligibility criteria:

        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

          -  Bowel disease questionnaire (BDQ) - IBS symptoms: Positive by Rome lll criteria

          -  No restrictions on Hospital Anxiety/Depression Score (HADS).

          -  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, serotonin-norepinephrine reuptake inhibitors (SNRI)
                  antidepressants.

               -  Analgesic drugs including opiates, nonsteroidal anti-inflammatory drugs (NSAID),
                  cyclooxygenase-2 (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 aspartate
             aminotransferase (AST)/ alanine transaminase (ALT) 2.0 X upper limit of normal.

               -  Bile acid (BA) synthesis and possible false positive or negative fecal bile acid
                  or serum 7alpha-hydroxy-4-cholesten-3-one (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.