Fecal Bile Acid Measurement in Patients with Microscopic Colitis before and after Colesevelam Treatment

Overview

  • Study type

    Interventional
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Rochester, Minnesota: 15-005547
    Sponsor Protocol Number: 15-005547

About this study

The purpose iof this study is to assess the correlation of the fecal bile acid test results and response to treatment with colesevelam in patients with MC who are diagnosed at Mayo Clinic.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

  • Chronic diarrhea (>6 weeks, >3 BM/day) with histologic evidence of MC by standard criteria, diagnosed or reviewed by a Mayo pathologist
  • Females must be either surgically sterilized, postmenopausal (>12 months since last menses), or if of childbearing potential, they will have a negative pregnancy test before initiation of medication and will agree to practice a highly effective form of birth control.

Exclusion Criteria: 

  • Ileal surgery or history of Crohn’s disease, ulcerative colitis or celiac disease
  • Prior non-response to bile acid binding medications
  • Use of the following drugs or agents within the past 1 week or planned use in the subsequent 2 weeks during the study period:
    • Agents that alter GI transit including opioids, narcotics
    • Analgesic drugs including opiates, NSAID, COX 2 inhibitors
    • Bile acid medications (ie ursodeoxycholic acid)
    • Cholesterol lowering medications (e.g. statins)
    • Intake of any other medication that could interfere with the interpretation of the study.
  • Female subjects who are pregnant or breast-feeding.
  • Gastrointestinal surgery (except appendectomy or cholecystectomy)
  • Patients with known chronic liver disease or elevated AST or ALT >=2.0 X upper limit of normal.
  • Antibiotic use within 4 weeks of enrollment, or planning to receive antibiotic during the course of the study.
  • History of bowel obstructions
  • Triglycerides > 500 or TAG induced pancreatitis
  • Use of the following medication; immunosuppression with cyclosporine or mycophenolate, warfarin, phenytion

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Darrell Pardi, M.D.

Open for enrollment

Contact information:

Patricia Kammer

(507)538-1827

Kammer.Patricia@mayo.edu

.
CLS-20308381

Mayo Clinic Footer