Immune Response in Celiac Disease on In-vitro Gluten Challenge

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ClinicalTrials.gov Identifier: NCT01909050

Recruitment Status : Completed

First Posted : July 26, 2013

Last Update Posted : March 19, 2018

Sponsor:

Information provided by (Responsible Party):

Daniel Leffler, Beth Israel Deaconess Medical Center

Study Description

Brief Summary:

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 or disease
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.

Study Design


Study Type :	Observational
Actual Enrollment :	42 participants
Observational Model:	Other
Time Perspective:	Prospective
Official Title:	An In-vitro Gluten Challenge on the Immunologic Response in Celiac Disease.
Actual Study Start Date :	February 2013
Actual Primary Completion Date :	January 2018
Actual Study Completion Date :	March 2018

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Celiac disease

MedlinePlus related topics: Celiac Disease

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
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.

Outcome Measures

Primary Outcome Measures :

change in interferon gamma [ Time Frame: 0, 6, and 24 hours ]
in vitro culture stimulated with gluten

Secondary Outcome Measures :

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

Biospecimen Retention: Samples With DNA

Duodenal biopsy samples

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 75 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:	Daniel Leffler, Associate Professor of Medicine, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:	NCT01909050 History of Changes
Other Study ID Numbers:	2012P000354
First Posted:	July 26, 2013 Key Record Dates
Last Update Posted:	March 19, 2018
Last Verified:	March 2018

Keywords provided by Daniel Leffler, 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

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