Immune Response in Celiac Disease on In-vitro Gluten Challenge

Completed

• Conditions: Celiac Disease

• Registration Number: NCT01909050
• Lead Sponsor: Beth Israel Deaconess Medical Center

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.

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 Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-07-18
• Study First Submitted QC: 2013-07-24
• Study First Posted: 2013-07-26
• Primary Completion: 2018-01
• Status Verified: 2018-03
• Study Completion: 2018-03
• Last Update Submitted: 2018-03-16
• Last Update Posted: 2018-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
change in interferon gamma	0, 6, and 24 hours	in vitro culture stimulated with gluten

Secondary Outcome Measures

Name	Time	Method
change in interleukin-21	0, 6, and 24 hours	in vitro culture stimulated with gluten
change in interleukin-15	0, 6, and 24 hours	in vitro culture stimulated with gluten
change in interleukin-18	0, 6, and 24 hours	in vitro culture stimulated with gluten

Trial Locations

Locations (1)

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States