Ability of Mayo Clinic HPLC Method to Measure Fecal Bile Acids

  • Study type:

    Observational What is this?

    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.

Study IDs

  • Site IRB:

    • Rochester, Minnesota: 14-000384
  • NCT ID:

    NCT02111603
  • Sponsor Protocol Number:

    14-000384

About this study

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

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

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

  • BDQ- IBS symptoms: Positive by Rome lll criteria
  • HAD: No restrictions on Hospital Anxiety/Depression score.
  • Age: 18-65 years
  • 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, SNRI antidepressants.
    • Analgesic drugs including opiates, NSAID, 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 AST/ALT 2.0 X upper limit of normal.
    • BA synthesis and possible false positive or negative fecal bile acid or serum 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.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Michael Camilleri, M.D.

Closed for enrollment