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Single-dose Linaclotide for Capsule Endoscopy Preparation

NCT02465385 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2016-07-14

No results posted yet for this study

Summary

Video capsule endoscopy is an important procedure that can be used by doctors to find abnormalities in the small intestine, especially those that can cause bleeding. The procedure uses a tiny wireless camera to take pictures of the digestive tract. The camera sits inside a vitamin-sized capsule that a person can swallow. As the capsule travels through the digestive tract, the camera takes thousands of pictures that are transmitted to a recorder worn on a belt around a person's waist or over his/her shoulder. However, abnormalities can be missed partly because the normal dark liquids present in the intestine can prevent abnormalities from being recorded, hiding them from the physician who reviews the video.

The current method used to clear these dark liquids from your small intestine is to follow a clear liquid diet and drink approximately 2 quarts of polyethylene glycol (Golytely®) the day before the video endoscopy and take simethicone (a medication used to treat symptoms of gas such as uncomfortable or painful pressure, fullness, and bloating) the morning of the test.

Some of the current preparations to clear these dark liquids are not able to entirely prevent abnormalities from being missed and most have an unpleasant taste or involve drinking a lot of fluid.

Linaclotide (Linzess®) is a medication approved by the Food and Drug Administration (FDA) for the treatment of constipation and irritable bowel syndrome. It is not approved by the FDA for use as an aid for clearing dark liquid from the small intestine prior to a video endoscopy.

A recent presentation at a medical meeting proposed using one-dose of linaclotide (Linzess®) to improve cleansing of the small intestine for capsule endoscopy preparation to supplement fasting and clear liquid diet.

This report claimed a noticeably better quality of small intestine cleansing and a 20% shorter transit time for the capsule by taking one dose of linaclotide one hour before patients swallowed the video capsule.

The purpose of this study is to assess the use of one dose of linaclotide in terms of the total time it takes the capsule to move through the small bowel, and image quality as compared to the current method. The results of this study will be compared to previous patients who drank the preparation that is currently used

Conditions

Interventions

DRUG

Linaclotide

Every participant with be given 290 mcg of linaclotide 1 hour prior to receiving their capsule, in place of the standard (golytely) preparation

Sponsors & Collaborators

  • University of Virginia

    lead OTHER

Principal Investigators

  • Rachel Hays, MD · Assistant professor

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2016-06-30
Completion
2016-06-30

Countries

  • United States

Study Locations

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Entities

Diseases

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 NCT02465385 on ClinicalTrials.gov