Immune Response in Celiac Disease on In-vitro Gluten Challenge

Celiac Disease Clinical Trial

Official title:

An In-vitro Gluten Challenge on the Immunologic Response in Celiac Disease.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01909050
• Other study ID #: 2012P000354
• Status: Completed
• First received: July 18, 2013
• Last updated: March 16, 2018
• Start date: February 2013
• Est. completion date: March 2018

Study information

• Verified date: March 2018
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: March 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Celiac Disease

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in interferon gamma	in vitro culture stimulated with gluten	0, 6, and 24 hours
Secondary	change in interleukin-15	in vitro culture stimulated with gluten	0, 6, and 24 hours
Secondary	change in interleukin-18	in vitro culture stimulated with gluten	0, 6, and 24 hours
Secondary	change in interleukin-21	in vitro culture stimulated with gluten	0, 6, and 24 hours