Single-dose Linaclotide for Capsule Endoscopy Preparation

July 13, 2016 updated by: R. Ann Hays, MD, University of Virginia

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Video capsule endoscopy is an important modality for detection of lesions in the small intestine. It is particularly helpful in patients with occult sources of gastrointestinal bleeding, suspected Crohn's disease, ulcerative jejunitis, and in cases where a small intestinal neoplasm is suspected. Despite advances in technique and equipment, significant limitations remain in obtaining adequate visualization due to dark bilious fluid that obscures the mucosa. Furthermore, limitations of battery technology mean that in approximately 16.5% of studies the capsule will fail to visualize the entire small bowel. Numerous methods of bowel preparation have been used for capsule endoscopy. To date, all of them are unpleasant/have significant side effects. This is particularly onerous given that the majority has already had a similar but more extensive preparation for colonoscopy. Furthermore, overall efficacy is varied, and the preparation frequently remains suboptimal. The University of Virginia Health System Motility Lab uses a current regimen of 2000 mL of golytely and simethicone, but incomplete and partially occluded portions of the small bowel remain persistent clinical issues. Nearly one in five studies may ultimately have to be repeated as a result.

A recent presentation by Ira J. Schmelkin, M.D. proposed the use of single-dose linaclotide for capsule endoscopy preparation to supplement fasting and clear liquid diet. In an uncontrolled series, he noted a clinically significant improvement in preparation quality and a 20% shorter transit time (compared with published norms) with one higher range dose of linaclotide an hour prior to endoscopy. Linaclotide is guanylate cyclase-C that acts on the luminal surface of the intestinal epithelium thereby stimulating secretion of chloride and bicarbonate into the intestinal lumen, resulting in increased intestinal fluid and increased motility. The increased motility and secretion throughout the gastrointestinal tract make it a potentially useful agent to decrease capsule transit time and decrease the amount of dark small intestine fluid, thereby improving capsule endoscopy yield. Initial reports suggest that linoclotide is generally well tolerated, with the primary side effect of diarrhea. The investigators propose to study the use of a single dose for capsule endoscopy preparation.

The hypothesis is that single-dose linaclotide will lead to significantly decreased transit time and improved small bowel visualization quality when compared to controls using polyethylene glycol and simethicone (standard of care).

The investigators propose to prospectively enroll approximately 30 patients as subjects, who will receive a single dose of 290mcg one hour prior to capsule endoscopy. This was calculated using power calculations from values of the Viazis study, who noted an average transit time of approximately 290 minutes, compared with approximately 190 minutes in the data from Schmelkin. Given the standard deviation of approximately 90 minutes in Viazis, power calculation with an alpha of 0.05 and a beta of 0.80 would require 18 subjects per group. The investigators will target 30 to allow for dropouts and to allow the use of statistics pertaining to large (approximately 30 and up) numbers of subjects.

All adult patients undergoing capsule endoscopy (with the exception of certain criteria, such as severe gastroparesis, pregnancy, non-English speaking, prisoners, those unable to give consent, prior small intestinal resection) will be approached sequentially until completion of the study. These will be matched 1:1 with historic controls selected at random from cases in the prior three years. The same exclusion criteria will be applied to both groups. There will be two primary outcomes: total transit time and rated overall mucosal visualization (categorized as ideal, good, inadequate or poor/needs repetition). Primary analysis will presume no confounding and use a t-test and chi-square, respectively. Should the groups prove significantly different, the investigators also plan to use adjusted analysis. The investigators will plan to collect BMI, history of reflux, age, sex, gastroparesis, diabetes, narcotic use, other conditions e.g. Parkinson's, lupus, scleroderma as these may affect transit time for the historic controls.

Two gastrointestinal fellows or attending level gastroenterologists will perform the scoring of the images recorded during the capsule endoscopy in a blinded manner. Secondarily, the investigators will also look at the percentage of capsule endoscopies detecting a culprit lesion, and the percentage of failed (incomplete) studies.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • University of Virginia Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • Linzess

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
10 hours post-dose

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
10 hours post-dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Virginia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Rachel Hays, MD, Assistant Professor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 27, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 3, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 8, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 14, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 13, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 17803 (OTHER: HSR Submission Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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