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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: September 6, 2016
Last verified: September 2016
History of Changes
  Purpose

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.

Condition
Celiac Disease

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: An In-vitro Gluten Challenge on the Immunologic Response in Celiac Disease.

Resource links provided by NLM:

MedlinePlus related topics: Celiac Disease
U.S. FDA Resources

Further study details as provided by Beth Israel Deaconess Medical Center:

Primary Outcome Measures:
  • change in interferon gamma [ Time Frame: 0, 6, and 24 hours ] [ Designated as safety issue: No ]
    in vitro culture stimulated with gluten


Secondary Outcome Measures:
  • 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


Biospecimen Retention:   Samples With DNA
Duodenal biopsy samples

Estimated Enrollment: 40
Study Start Date: February 2013
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

Detailed Description:

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.

  Eligibility
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects will be selected from patients undergoing a clinically indicated upper endoscopy at Beth Israel Deaconess Medical Center
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01909050

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Investigators
Principal Investigator: Daniel A Leffler, MD, MS Beth Israel Deaconess Medical Center
  More Information

Responsible Party: Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT01909050     History of Changes
Other Study ID Numbers: 2012-P-000354 
Study First Received: July 18, 2013
Last Updated: September 6, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Beth Israel Deaconess Medical Center:
celiac disease
refractory celiac disease
gluten sensitivity

Additional relevant MeSH terms:
Celiac Disease
Malabsorption Syndromes
Intestinal Diseases
 Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases

ClinicalTrials.gov processed this record on September 23, 2016