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Single-dose Linaclotide for Capsule Endoscopy Preparation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02465385
Recruitment Status : Completed
First Posted : June 8, 2015
Last Update Posted : July 14, 2016
Information provided by (Responsible Party):
R. Ann Hays, MD, University of Virginia

Brief 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

Condition or disease Intervention/treatment Phase
Crohn's Ulcerative Colitis Gastrointestinal Bleeding Drug: Linaclotide Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Single-dose Linaclotide for Capsule Endoscopy Preparation
Study Start Date : February 2015
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Arm Intervention/treatment
Experimental: Intervention
Linaclotide 290mcg
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
Other Name: Linzess

Primary Outcome Measures :
  1. Small bowel transit time [ Time Frame: 10 hours post-dose ]
    The time of transit will be reviewed on the following day after the study. The data is collected when the capsule is finished recording, approximately 10 hours post-dose

Secondary Outcome Measures :
  1. Overall mucosal visualization on the recorded images as rated by an expert reviewer and graded on a 5-point likert scale. [ Time Frame: 10 hours post-dose ]
    The mucosal visualization will be reviewed on the following day after the study. The data is collected when the capsule is finished recording, approximately 10 hours post-dose

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Schedule for video endoscopy at UVHS
  • Ability to speak, read and write English
  • Age >18
  • Able to provide consent

Exclusion Criteria:

  • Prisoner
  • Woman who is currently pregnant or breastfeeding
  • Allergy to linaclotide
  • Patients with known or suspected mechanical gastrointestinal obstruction

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02465385

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United States, Virginia
University of Virginia Health System
Charlottesville, Virginia, United States, 22903
Sponsors and Collaborators
University of Virginia
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Principal Investigator: Rachel Hays, MD Assistant professor
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: R. Ann Hays, MD, Assistant Professor, Gastroenterology, University of Virginia Identifier: NCT02465385    
Other Study ID Numbers: 17803
First Posted: June 8, 2015    Key Record Dates
Last Update Posted: July 14, 2016
Last Verified: July 2016
Additional relevant MeSH terms:
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Colitis, Ulcerative
Gastrointestinal Hemorrhage
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases
Pathologic Processes
Guanylyl Cyclase C Agonists
Enzyme Activators
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents