Capsule Endoscopy in Celiac Disease - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Celiac Disease

Intervention / Treatment

Device: Capsule Endoscopy

Detailed Description

Gluten-sensitive enteropathy (GSE), also known as celiac disease, is characterized by abnormal small intestinal mucosa arising as a consequence of an inappropriate inflammatory response to ingested gluten in susceptible individuals.

These changes cause a loss of absorptive capacity which in turn leads to variable degrees of malabsorption. A person suffering from celiac may have symptoms ranging from mild iron deficiency anemia to severe diarrhea and weight loss. Characteristically, removal of gluten from the diet is followed by resolution of the mucosal changes and the symptoms.

Celiac disease is suspected on the basis of clinical signs and symptoms, and is generally confirmed by serological testing and small bowel biopsy. Patients with suspected celiac disease undergo upper GI endoscopy with mucosal biopsy of the duodenum, in order to detect the characteristic histological changes.

Although the main role for endoscopy in GSE is to obtain tissue for histological examination, a variety of endoscopic changes have been described in these patients,such as nodularity of the mucosa and 'scalloping' or loss of the duodenal mucosal folds.

The Given® Diagnostic System can visually investigate the small bowel, producing high-quality images of the mucosa, which might be able to detect villous atrophy and thus could be used in the assessment of patients with GSE. Whereas upper GI endoscopy is invasive, often requires sedation and may be uncomfortable, Capsule Endoscopy is less invasive, convenient to use and does not require sedation.

Capsule Endoscopy could become an important tool for the non-invasive assessment of small bowel mucosa in GSE.

Study Type

Observational

Enrollment (Actual)

102

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

Finland
- - Tampere, Finland
    - University of Tampere Medical School
Italy
- - Milano, Italy, 20122
    - Ospedale Maggiore - Policlinico
  - Rome, Italy
    - Universita Cattolica del Sacro Cuore
  - Torino, Italy
    - San Giovanni A.S. Hospital
United States
- Massachusetts
  - Worcester, Massachusetts, United States, 01655
    - University of Massachusetts Memorial Medical Center

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

Sampling Method

Probability Sample

Study Population

clinic paitnets with known Gluten sensitivity (Celaic).

Description

Inclusion Criteria:

Patient age is 18 years or older
Patient agrees to sign the Informed Consent Form
Patient has positive celiac serology or negative celiac serology + IgA deficiency and suffers from one or more of the following symptoms and/or abdominal biochemical values:
1. Chronic diarrhea
2. Weight loss
3. Abdominal cramps
4. History of spontaneous abortion
5. Iron deficiency anemia
6. Osteoporosis
7. Infertility
8. Hypoalbuminaemia
9. Low cholesterol
10. Low prothrombin activity

Exclusion Criteria:

Patient is known or is suspected to suffer from intestinal obstruction.
Patient has a cardiac pacemaker or other electro-medical device.
Patient suffers from severe swallowing disorder or Zenker's diverticulum
Patient has any condition, which precludes compliance with study and/or device instructions.
Female patient is pregnant
Patient suffers from life threatening conditions
Patient is currently participating in another clinical study.

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

Observational Models: Cohort
Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The number of findings identified during the capsule endoscopy or upper GI endoscopy procedure, and which were considered by the investigator as related to the gluten sensitive enteropathy origin Time Frame: within 14 days of enrollment	within 14 days of enrollment

Secondary Outcome Measures

Outcome Measure	Time Frame
Longitudinal extent of villous changes in the small bowel will be evaluated. Time Frame: within 14 days of enrollment	within 14 days of enrollment

Collaborators and Investigators

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

Sponsor

Medtronic - MITG

Investigators

Principal Investigator: Roberto de Franchis, MD, Prof., Ospedale Maggiore - Policlinico, Milano, Italy

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

November 1, 2003

Study Completion (Actual)

July 1, 2007

Study Registration Dates

First Submitted

November 8, 2007

First Submitted That Met QC Criteria