Phase 2
N=30
Trial to Understand Efficacy of Colesevelam in Diarrhea Predominant IBS Patients With Bile Acid Malabsorption
Chronic Diarrhea · Irritable Bowel Syndrome With Diarrhea · Bile Acid Malabsorption
Bottom Line
View on ClinicalTrials.gov: NCT03270085 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Apr 2020
Primary outcome: Primary: Total Fecal Bile Acid (BA) Excretion — 10.7; 3.6 μmoles/g — p=0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Colesevelam (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- May 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Fecal Bile Acid (BA) Excretion |
10.7; 3.6 | 0.001 sig |
| PRIMARY Stool Consistency |
4.6; 4.6 | 0.81 |
| SECONDARY Number of Stools Per Day |
3.1; 2.2 | 0.91 |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03270085). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.