Trial to Understand Efficacy of Colesevelam in Diarrhea Predominant IBS Patients With Bile Acid M… (NCT03270085) | Clinical Trial Compass
CompletedPhase 2
Trial to Understand Efficacy of Colesevelam in Diarrhea Predominant IBS Patients With Bile Acid Malabsorption
United States30 participantsStarted 2017-12-07
Plain-language summary
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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
* Females and males age 18 -75.
* An IBS diagnosis based on the Rome III criteria for at least 3 months, with onset at least 6 months previously, of recurrent abdominal pain or discomfort.
* Biomarkers serum alpha C4 ≥ 40 ng/mL or FGF19 ≤ 80 pg/mL or fecal bile acid \>2000 micromoles/48h
Exclusion Criteria:
* IBS patients with known clinically-relevant inflammation.
* IBS patient with known bleeding diathesis
* History of abdominal surgery
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:
* Any treatment specifically taken for IBS-D, including loperamide, cholestyramine, alosetron
* Drugs with a known pharmacological activity at 5-HT4, 5-HT2b or 5-HT3 receptors
* All narcotics
* Anti-cholinergic agents
* Tramadol
* Oral anticoagulants
* Antimuscarinics
* Peppermint oil
* Systemic antibiotics, as well as antibiotics directed at colonic flora such as rifaximin and metronidazole
Gastrointestinal preparations:
* Anti-nausea agents
* Osmotic laxative agents
* Prokinetic agents
* 5-HT3 antagonists