Trial record 41 of 841 for:    "ulcerative colitis"

Wireless Capsule Endoscopy in Ulcerative Colitis

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: NCT00145808
Recruitment Status : Completed
First Posted : September 5, 2005
Last Update Posted : September 5, 2013
Prometheus Laboratories
American College of Gastroenterology
Information provided by (Responsible Party):
University of Chicago

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Device: Given® Diagnostic System Phase 3

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  (Clinical Trial)
Estimated Enrollment : 116 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Prospective Controlled Assessment of Wireless Capsule Endoscopy (WCE) in Ulcerative Colitis (UC)
Study Start Date : June 2005
Actual Primary Completion Date : June 2007
Actual Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Assess the prevalence of small bowel abnormalities in UC patients compared to controls.

Secondary Outcome Measures :
  1. Ensure safety of subjects by confirming passage of the capsule.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

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): NCT00145808

United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Prometheus Laboratories
American College of Gastroenterology
Principal Investigator: David Rubin, MD University of Chicago

Responsible Party: University of Chicago Identifier: NCT00145808     History of Changes
Other Study ID Numbers: 13215A
First Posted: September 5, 2005    Key Record Dates
Last Update Posted: September 5, 2013
Last Verified: September 2013

Keywords provided by University of Chicago:
Ulcerative colitis

Additional relevant MeSH terms:
Colitis, Ulcerative
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases