Investigation of Linaclotide's Effect on the Bi-directional Brain and Gut Axis in IBS-C Patients

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.

Timeline

Start

2014-02

Primary completion

2017-10-04

Completion

2018-07-20

Publications

• Rao SSC, Xiang X, Yan Y, Rattanakovit K, Patcharatrakul T, Parr R, Ayyala D, Sharma A. Randomised clinical trial: linaclotide vs placebo-a study of bi-directional gut and brain axis. Aliment Pharmacol Ther. 2020 Jun;51(12):1332-1341. doi: 10.1111/apt.15772. Epub 2020 May 13.

Drugs

Indications