Single-dose Linaclotide for Capsule Endoscopy Preparation
Status:
Completed
Trial end date:
2016-06-01
Target enrollment:
Participant gender:
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