Clinical Trials

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