Wireless Capsule Endoscopy in Ulcerative Colitis

September 4, 2013 updated by: University of Chicago

Prospective Controlled Assessment of Wireless Capsule Endoscopy (WCE) in Ulcerative Colitis (UC)

Based on the inaccuracies of the current classification scheme for inflammatory bowel disease (IBD), the failure of surgical pouches and the findings of retrospective observational trials to date, we hypothesize that a significant proportion of patients with UC will have small bowel involvement that will result in a change in diagnosis to CD or the recognition of a new phenotype of IBD. The aim of this study is to determine the prevalence of small bowel pathology in patients diagnosed with UC using WCE. This information will aid in the current efforts to re-classify IBD using improved endoscopic and imaging technologies, genetic information and serologic information.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Subjects will undergo both a blood draw and a wireless capsule endoscopy (WCE).

The blood draw will occur in the GI procedure unit on the day of subjects exam.

WCE: Subject will only consume a clear liquid diet after noon the day prior to the exam. No food or beverage consumption any after 10 PM on the day before examination. Not oral medications after 12 AMon the day of exam (8 hours before subject's exam).

Day of exam, subject will report to the endoscopy unit. At that time, subject will be prepared for examination by doctor who will apply a sensor array to the abdomen with adhesive sleeves. In addition, a waist belt device that holds the data recorder will be fitted to subject. Subjects will swallow the capsule endoscope. The capsule endoscope passes naturally through digestive tract while transmitting video images to the data recorder worn on the belt for approximately eight hours. At this point, subjects will be free to leave the University of Chicago hospital until they return eight hours later for disconnection of the recording equipment.

Two hours after ingestion of the capsule, subject will be able to resume a clear liquid diet. Four hours after the study's start time, subject will be able to resume a regular diet ( solid foods). At this time, subject will also be able to resume taking oral medications.

After eight hours, subject will return to the endoscopy suite (DCAM 6H) for disconnection of the recording equipment (sensor array, data recorder, and belt). The time that the capsule was ingested, eating and drinking times, and disconnection time as well as any discomfort subject experienced will be recorded.

Subject will be contacted 72 hours after the examination to confirm passage of the capsule. If they have not reported passage of the capsule with this time, subject will undergo an abdominal radiograph in order to determine whether or not the capsule has passed.

Subjects will be asked to identify a non-relative control (spouses are acceptable) within five years of their age and of similar background without Ulcerative Colitis. There is an Information Handout that participating subjects will give to friends interested in participating. If the subject does not find anyone, they may still participate in this research study. The study staff will try to find someone for them.

Study Type

Interventional

Enrollment (Anticipated)

116

Phase

  • Phase 3

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
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Inclusion criteria for the "disease" arm include a clinical impression of ulcerative colitis that includes assessment of the colon by colonoscopy and biopsy and assessment of the terminal ileum either by ileoscopy or by small bowel radiograph or enteroclysis. Subjects in the "control" arm will only be included if they do not carry the diagnosis of UC or CD, have not had previous gastric or small bowel surgery and are free of gastrointestinal symptoms including unexplained abdominal pain, diarrhea or gastrointestinal bleeding.

Exclusion Criteria:

A known bowel obstruction, fistula or stricture, a permanent pacemaker and/or implantable defibrillator, history of a swallowing disorder, inability to provide informed consent, pregnancy, the use of aspirin or non-steroidal anti-inflammatory drugs (NSAIDs) within the past 30 days, known celiac disease, known terminal ileal disease on ileoscopy and a history of occult or obscure gastrointestinal bleeding of unclear etiology. In menstruating females, a urine HCG will be performed on the day they arrive for the study (prior to ingestion of the capsule), if fourteen (14) days or more have elapsed since their last menstrual period. If subject reports they are menopausal, a urine HCG will be performed unless subject has had no menses during the past two years.

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

  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Assess the prevalence of small bowel abnormalities in UC patients compared to controls.

Secondary Outcome Measures

Outcome Measure
Ensure safety of subjects by confirming passage of the capsule.

Collaborators and Investigators

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

Sponsor

University of Chicago

Collaborators

Prometheus Laboratories
American College of Gastroenterology

Investigators

  • Principal Investigator: David Rubin, MD, University of Chicago

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

June 1, 2005

Primary Completion (Actual)

June 1, 2007

Study Completion (Actual)

November 1, 2008

Study Registration Dates

First Submitted

September 1, 2005

First Submitted That Met QC Criteria

September 2, 2005

First Posted (Estimate)

September 5, 2005

Study Record Updates

Last Update Posted (Estimate)

September 5, 2013

Last Update Submitted That Met QC Criteria

September 4, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13215A

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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