Investigation of Linaclotide's Effect on the Bi-directional Brain and Gut Axis in IBS-C Patients
Status:
Completed
Trial end date:
2018-07-20
Target enrollment:
Participant gender:
Summary
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.