Wireless Capsule Endoscopy in Ulcerative Colitis
Completed · Phase 3
Conditions studied: Ulcerative Colitis
In brief
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.
Key facts
- Study ID
- NCT00145808
- Run by
- University of Chicago
- People needed
- 116
- Starts
- 2005-06-01
- Expected to finish
- 2008-11-01
- Last updated by the study team
- 2013-09-05
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- University of Chicago — Chicago, Illinois, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.