Single-dose Linaclotide for Capsule Endoscopy Preparation

NCT02465385 | Completed Phase 4

• 1 other identifier: 17803
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Crohn's; Ulcerative Colitis; Gastrointestinal Bleeding

Outcome Measures

Primary Outcomes (1)

• Small bowel transit time

  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

  10 hours post-dose

Secondary Outcomes (1)

• Overall mucosal visualization on the recorded images as rated by an expert reviewer and graded on a 5-point likert scale.

  10 hours post-dose

Study Arms (1)

Intervention

EXPERIMENTAL

Linaclotide 290mcg

Drug: Linaclotide

Interventions

Linaclotide DRUG

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

Also known as: Linzess

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

University of Virginia Health System

Charlottesville, Virginia, 22903, United States

Location

Related Publications (1)

• Stein DJ, Copland A, McDaniel D, Hays RA. Single-Dose Linaclotide Is Equal in Efficacy to Polyethylene Glycol for Bowel Preparation Prior to Capsule Endoscopy. Dig Dis. 2019;37(4):297-302. doi: 10.1159/000496350. Epub 2019 Feb 7.

  PMID: 30731474 DERIVED

MeSH Terms

Conditions

Colitis, Ulcerative; Gastrointestinal Hemorrhage

Interventions

linaclotide

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Rachel Hays, MD

  Assistant professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Gastroenterology

Study Record Dates

• First Submitted: May 27, 2015
• First Posted: June 8, 2015
• Study Start: February 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: July 14, 2016

Record last verified: 2016-07

Locations

US (1)