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Immune Response in Celiac Disease on In-vitro Gluten Challenge

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT01909050
First received: July 18, 2013
Last updated: July 22, 2014
Last verified: July 2014

July 18, 2013
July 22, 2014
February 2013
December 2014   (final data collection date for primary outcome measure)
change in interferon gamma [ Time Frame: 0, 6, and 24 hours ] [ Designated as safety issue: No ]
in vitro culture stimulated with gluten
Same as current
Complete list of historical versions of study NCT01909050 on ClinicalTrials.gov Archive Site
  • change in interleukin-15 [ Time Frame: 0, 6, and 24 hours ] [ Designated as safety issue: No ]
    in vitro culture stimulated with gluten
  • change in interleukin-18 [ Time Frame: 0, 6, and 24 hours ] [ Designated as safety issue: No ]
    in vitro culture stimulated with gluten
  • change in interleukin-21 [ Time Frame: 0, 6, and 24 hours ] [ Designated as safety issue: No ]
    in vitro culture stimulated with gluten
Same as current
Not Provided
Not Provided
 
Immune Response in Celiac Disease on In-vitro Gluten Challenge
An In-vitro Gluten Challenge on the Immunologic Response in Celiac Disease.

The main purpose of this study is to see how cells taken from the lining of the intestine behave in the laboratory with exposure to gluten and other substances that act on the immune system. The cells lining the intestine of a person with celiac disease should be different than a person without celiac disease. The study doctors would like to see how the cells react after coming in contact with gluten and if substances that act on the immune system can prevent gluten related inflammation. Examples of these substances include steroids. The cells should produce chemicals of their own in response to the gluten. These other chemicals will be measured and the results compared between those with:

  • celiac disease that does not respond to a gluten-free diet (refractory celiac disease)
  • celiac disease which is controlled by a gluten-free diet
  • uncontrolled celiac disease (either newly diagnosed with celiac disease or not on a gluten-free diet
  • gluten-sensitivity
  • disorders other than celiac disease.

The primary purpose of this study is to determine the effect of in-vitro introduction of gluten on inflammatory response primarily Interferon-γ and other cytokines, such as IL-15, IL-18 and IL-21, in cultures obtained from small intestinal mucosal biopsy samples of subjects who underwent upper endoscopy.

Secondary goals include comparing the inflammatory response to immunosuppressants and cytokines after exposing the cultures obtained from small intestinal mucosal biopsies taken from RCD I subjects with intestinal mucosal biopsies taken from subjects with CeD controlled on a Gluten-Free Diet (GFD), uncontrolled CeD, Gluten sensitivity and Non-celiac Controls.

Observational
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Duodenal biopsy samples

Non-Probability Sample

Subjects will be selected from patients undergoing a clinically indicated upper endoscopy at Beth Israel Deaconess Medical Center

Celiac Disease
Not Provided
  • refractory celiac disease
  • well-controlled celiac disease
  • uncontrolled celiac disease
    either newly diagnosed with celiac disease or not on a gluten-free diet
  • gluten-sensitivity
  • disorders other than celiac disease.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
40
Not Provided
December 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 18-75 years of age
  • Undergoing a clinically indicated upper endoscopy

Exclusion Criteria:

  • Anticoagulation or antiplatelet therapy
  • Known active non-celiac intestinal inflammatory disorder
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01909050
2012-P-000354
No
Beth Israel Deaconess Medical Center
Beth Israel Deaconess Medical Center
Not Provided
Principal Investigator: Daniel A Leffler, MD, MS Beth Israel Deaconess Medical Center
Beth Israel Deaconess Medical Center
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP