Irritable Bowel Syndrome Clinical Trial
Official title:
A Phase IIB Study to Evaluate the Effects of Welchol (Colesevelam Hydrochloride) on Colonic Transit, Intestinal Permeability and Bowel Function in Diarrhea-predominant Irritable Bowel Syndrome (D-IBS)
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.
Background:
Irritable bowel syndrome (IBS) affects about 15% of the U.S. population, about 5% having
predominant diarrhea; current treatment is suboptimal as it may not be tolerated, lead to
side effects or insufficient benefit. Bile acid malabsorption (BAM) is recognized as a cause
of chronic diarrhea and has been investigated as a mechanism for the phenotype of diarrhea
predominant IBS (D-IBS). Increased exposure of the colon to bile acids which may result from
accelerated small bowel transit or abnormal function of the apical sodium bile acid
transporter (ASBT) has been postulated to cause functional diarrhea or symptoms of D-IBS by
a number of mechanisms, such as increase colonic secretion, and mucosal permeability. Recent
preliminary data suggest that doses of chenodeoxycholate (CDC) that are approved for the
dissolution of gall stones are associated with accelerated colonic emptying and looser stool
consistency.
Hypothesis:
The bile acid binding agent, Colesevelam HCl, decreases colonic transit and permeability in
patients with D-IBS.
Specific Aim:
To investigate the effect of Colesevelam, which binds bile acids in the small intestine and
reduces the concentration of bile acids in the colon, on colonic transit, permeability and
the bowel function of patients with D-IBS.
Methods:
Twenty-four D-IBS participants will be randomized to placebo or treatment with Welchol
(Colesevelam HCL) 1.875 gram b.i.d. for 12-14 days. A baseline colon transit, 24 hour urine
for colon permeability, and blood for serum 7 alpha-hydroxy-4-cholesten-3-one (7 alpha-HCO)
will be measured and venous blood DNA will be collected and stored. The measurement of serum
7 alpha-hydroxy-4-cholesten-3-one (7 alpha-HCO), which is a measurement of hepatic
cholesterol synthesis, is closely related to the fecal loss of bile acids, and is a
validated method for screening for BAM. Following treatment for 12 days, transit and
permeability studies will be repeated. Bowel function symptoms will be recorded for the
duration of the study.
;
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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