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Immune Response in Celiac Disease on In-vitro Gluten Challenge

This study is enrolling participants by invitation only.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01909050
First Posted: July 26, 2013
Last Update Posted: March 27, 2017
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.
Information provided by (Responsible Party):
Daniel Leffler, Beth Israel Deaconess Medical Center
July 18, 2013
July 26, 2013
March 27, 2017
February 2013
January 2018   (Final data collection date for primary outcome measure)
change in interferon gamma [ Time Frame: 0, 6, and 24 hours ]
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 ]
    in vitro culture stimulated with gluten
  • change in interleukin-18 [ Time Frame: 0, 6, and 24 hours ]
    in vitro culture stimulated with gluten
  • change in interleukin-21 [ Time Frame: 0, 6, and 24 hours ]
    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
Observational Model: Other
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
December 2018
January 2018   (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
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01909050
2012P000354
No
Not Provided
Not Provided
Daniel Leffler, 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
March 2017