Irritable Bowel Syndrome Clinical Trial
Official title:
A Pilot Study to Assess the Effects of Lubiprostone on Gastrointestinal and Colonic Motility and pH in Patients With the Irritable Bowel Syndrome and Constipation (IBS-C)
Irritable bowel syndrome (IBS) is a common disorder which presents with abdominal pain or
discomfort in association with altered bowel habit. IBS is further subcategorized as three
types according to the predominant bowel movement pattern: IBS with constipation (IBS-C),
IBS with diarrhea (IBS-D), and mixed-IBS (IBS-M). The exact causes of IBS remain
incompletely understood, but proposed mechanisms include abnormal motility, visceral
hypersensitivity, abnormal brain-gut interactions, psychological distress, and altered GI
tract motility.
Lubiprostone, a novel drug that works by activating the colonic ClC-2 chloride channel, has
been approved for use in patients with chronic idiopathic constipation and recently approved
for the treatment of IBS-C in women aged 18 and older. By activating the ClC-2 chloride
channel in the colon, lubiprostone allows more fluid secretion into the intestinal lumen
which leads to softer stool consistency. In phase III clinical trials, patients with IBS-C
receiving lubiprostone have reported improvements in many symptoms such as abdominal pain
and constipation. However, there is limited physiologic data to explain how exactly
lubiprostone improves IBS-C symptoms.
The Smartpill is a novel non-digestible capsule that is capable of measuring intraluminal
pH, pressure, and temperature in the gastrointestinal (GI) tract. Smartpill has been shown
to accurately measure whole gut as well as regional (i.e. stomach, small bowel, colon)
transit time.
The primary aim of this study is to determine the effects of lubiprostone on whole GI tract
transit, colonic transit, motility, and intraluminal pH in patients with IBS-C through
evaluation with the Smartpill. The investigators propose to study the effect of lubiprostone
vs. placebo on these parameters, and secondarily to evaluate changes in these parameters
with differing doses of lubiprostone.
The investigators hypothesize that lubiprostone will increase whole GI and colonic transit
compared to placebo in patient with IBS. the investigators do not expect a change in
intraluminal pH with lubiprostone compared to placebo.
n/a
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
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