Phase 2
Completed N=24
Does Welchol (Colesevelam Hydrochloride) Improve Colonic Transit in Diarrhea-predominant Irritable Bowel Syndrome (D-IBS)?
Source: ClinicalTrials.gov NCT00911612 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Mar 2012
Primary outcomePrimary: Colonic Transit, Geometric Center at 24 Hours — 2.68; 3.30 units on a scale — p=0.22
Summary
Our hypothesis is that the medication approved for treatment of high blood cholesterol levels, Colesevelam HCl (WELCHOL), decreases colonic transit and permeability in patients with diarrhea due to irritable bowel syndrome.
This effect is thought to result from the effect of the medication on bile acids, which can cause diarrhea.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Colonic Transit, Geometric Center at 24 Hours |
2.68; 3.30 | 0.22 |
| PRIMARY Ascending Colon Emptying T1/2 |
18.85; 14.9 | 0.02 sig |
| SECONDARY Colonic Permeability as Measured by Cumulative Urinary Excretion of Mannitol 8-24 Hours |
64.3; 45.8 | — |
| SECONDARY Colonic Transit, Geometric Center at 48 Hours |
4.65; 4.47 | — |
| SECONDARY Stool Consistency |
3.78; 4.57 | — |
Eligibility Criteria
Inclusion Criteria
- Patients with D-IBS
- Aged 18-65 years
- No abdominal surgery (except appendectomy or cholecystectomy as long as patients IBS-diarrhea symptoms preceded the cholecystectomy
Exclusion Criteria
- Participants with known chronic liver disease or Aspartate aminotransferase (AST) or Alanine transaminase (ALT) > 2.0 X upper limit of normal
- Hypertriglyceridemia and pancreatitis by history
- Diabetes or hypoglycemia
- Significant coagulation disorder
- History of bowel obstruction
- Serum triglycerides >500 mg/dL
- History of vitamin A, D, E, or K deficiencies
Data sourced from ClinicalTrials.gov (NCT00911612). 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. Informational only — not medical advice.