Trial to Understand Efficacy of Colesevelam in Diarrhea Predominant IBS Patients With Bile Acid Malabsorption
Completed · Phase 2 · Has a placebo group
Conditions studied: Chronic Diarrhea, Irritable Bowel Syndrome With Diarrhea, Bile Acid Malabsorption
In brief
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.
Key facts
- Study ID
- NCT03270085
- Run by
- Mayo Clinic
- People needed
- 30
- Starts
- 2017-12-07
- Expected to finish
- 2019-05-31
- Last updated by the study team
- 2020-04-27
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Mayo Clinic in Rochester — Rochester, Minnesota, United States
Full record on ClinicalTrials.gov
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