Trial to Understand Efficacy of Colesevelam in Diarrhea Predominant IBS Patients With Bile Acid Malabsorption


About this study

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.

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. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Females and males age 18 -75 with a positive diagnosis of IBS based on the Rome III criteria. This criteria is: a diagnosis for at least 3 months, with onset at least 6 months previously, of recurrent abdominal pain or discomfort associated with 2 or more of the following:
    1. Improvement with defecation; and/or
    2. Onset associated with a change in frequency of stool; and/or
    3. Onset associated with a change in form (appearance) of stool (discomfort means an uncomfortable sensation not described as pain). BAM serum alpha C4 ≥ 40 ng/mL or FGF19 ≤ 80 pg/mL or fecal BA >2000 µmoles/48h.
  •  Total fecal BA > 1000 µmoles/48h + >4% primary BA, or >10% primary BA

Exclusion Criteria:

Patients diagnosed with IBS with known clinically-relevant inflammation bleeding diathesis will be excluded, given the need for sigmoid mucosal biopsies. 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:

  1. Any treatment specifically taken for IBS-D, including loperamide, cholestyramine, alosetron
  2. Drugs with a known pharmacological activity at 5-HT4, 5-HT2b or 5-HT3 receptors (e.g, tegaserod, ondansetron, tropisetron, granisetron, dolasetron, mirtazepine, cilansetron);
  3. All narcotics (e.g, codeine, morphine, and propoxyphene, either alone or in combination)
  4. Anti-cholinergic agents (e.g, dicyclomine, hyoscyamine, propantheline).
  5. Tramadol
  6. GI preparations:
    • Anti-nausea agents (e.g, trimethobenzamide, promethazine, prochlorperazine, dimenhydrinate, hydroxyzine);
    • Osmotic laxative agents (e.g, lactulose, sorbitol or PEG solutions as Miralax and Glycolax);
    • Prokinetic agents (e.g, cisapride, metoclopramide, prucalopride, domperidone);
    • 5-HT3 antagonists (e.g. alosetron)
  7. Oral anticoagulants
  8. Antimuscarinics
  9. Peppermint oil
  10. Systemic antibiotics, as well as antibiotics directed at colonic flora such as rifaximin and metronidazole

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Michael Camilleri, M.D.

Closed for enrollment

More information


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