Irritable Bowel Syndrome With Constipation (IBS-C) Clinical Trial
Official title:
Investigation of Linaclotide's Effect on the Bi-directional Brain and Gut Axis in IBS-C Patients
The purpose of this study is to understand how a drug called Linaclotide improves bowel
function and abdominal pain in patients with Irritable Bowel Syndrome with Constipation
(IBS-C) as well as to examine whether Linaclotide alters communication between the brain and
pelvic-floor region.
Linaclotide has been shown to improve abdominal pain and bowel symptoms in IBS-C, and is
approved by the FDA for the treatment of this condition. However, how exactly this drug works
to relieve abdominal pain and discomfort in humans is not clearly known. Studies in animal
models suggest that patients with IBS-C have hypersensitivity in the gut.
Consequently, in IBS-C patients, there is rapid and excessive conduction of signals both from
the brain and central nervous system region towards the pelvic-floor (anorectal axis) and the
reverse direction. The investigators hypothesize that treatment with Linaclotide may
improve/normalize these signals and thereby improve bowel symptoms.
Investigators will test this theory using a new, noninvasive (and established) method of
studying this communication pathway between the brain and gut.
modulate these mechanisms and thereby improve visceral pain.
Investigators propose three specific aims:
1. Examine the hyperexcitability of the afferent-pelvic floor brain axis in 60 patients
with IBS by measuring the cortical evoked potentials (CEP) and sensory thresholds after
electrical stimulation of the rectum and anus before and after administration of
linaclotide or placebo for a period of 10 weeks.
2. Study the efferent brain pelvic floor axis by stimulating the cortex with transcranial
magnetic stimulation and record the anal and rectal motor evoked potentials (MEP) in 60
IBS-C patients.
3. Determine the locus for neuronal modulation i.e are the neuroenteric changes due to
central or peripheral neuronal sensitization or both, by evoking anal and rectal MEPs
after selectively stimulating the lumbar and sacral nerves bilaterally, and by comparing
segmental with transcranial-induced MEPs.
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