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 range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.