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

NCT02078323 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2018-07-23

No results posted yet for this study

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.

Conditions

  • Irritable Bowel Syndrome With Constipation (IBS-C)

Interventions

DRUG

Linaclotide

DRUG

Placebo

Sponsors & Collaborators

  • Forest Laboratories

    collaborator INDUSTRY

  • Augusta University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2017-10-04
Completion
2018-07-20

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02078323 on ClinicalTrials.gov