Ability of Mayo Clinic HPLC Method to Measure Fecal Bile Acids to Demonstrate Response to Colesevelam in Patients With Diarrhea Predominant Irritable Bowel Syndrome
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Mayo Clinic
- Enrollment
- 13
- Locations
- 1
- Primary Endpoint
- Change in Total 48 Hour Fecal Bile Acids (BA) From Baseline in Response to Treatment With Colesevelam
Study Overview
Brief Summary
The investigators' hypothesis is that therapy with Colesevelam, reduces fecal bile acid excretion in patients with Irritable Bowel Syndrome (IBS)-diarrhea with prior evidence of increased fecal 48 hour total bile acid excretion. The investigators aim to study the ability of the HPLC assay for fecal bile acids to demonstrate responsiveness after treatment with Colesevelam.
Detailed Description
This study will evaluate whether Colesevelam, a bile acid sequestrant, is able to reduce fecal bile acids and improve bowel function in patients with IBS-diarrhea and Mayo's HPLC method can demonstrate a response to the Colesevelam.
The study design will be a single center, unblinded, single dose trial to study the ability to identify the effect of taking 1875 mg (3 tablets [625 mg/tablet]) of Colesevelam orally twice daily for ten days on fasting serum 7alphaC4 and total 48 hour fecal bile acid excretion. Stool and fasting serum samples will be collected predose and during final 48 hours' dosing for assessment. Participants will also fill out an 8-day stool diary assessing frequency, consistency, ease of passage of bowel movements before and during treatment with Colesevelam.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Colesevelam
1875 mg of Colesevelam orally twice daily for 10 days
Intervention: Colesevelam (Drug)
Outcomes
Primary Outcomes
Change in Total 48 Hour Fecal Bile Acids (BA) From Baseline in Response to Treatment With Colesevelam
Time Frame: baseline, 10 days
Stool 48 hour collections (for BAs) were collected during baseline before treatment, and then during days 9-10 of the 10 days of colesevelam dosing for fecal BAs. Total fecal BA were measured using HPLC/tandem mass spectrometry.
Secondary Outcomes
- Change in Fasting Serum C4(baseline, 10 days)
- Change in Fecal Fat Excretion(baseline, 10 days)
- Change in Stool Consistency(baseline, 10 days)
- Change in Stool Frequency (Number of Stools Per Week)(baseline, 10 days)
- Concordance Correlation Coefficients of the Relative Composition of Stool Total and the Main Individual Bile Acids (BA)(baseline, 10 days)
Investigators
Michael Camilleri
MD
Mayo Clinic