Ignite Creation Date:
2025-12-24 @ 4:57 PM
Ignite Modification Date:
2026-01-22 @ 9:03 AM
Study NCT ID:
NCT01909050
Status:
COMPLETED
Last Update Posted:
2018-03-19
First Post:
2013-07-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immune Response in Celiac Disease on In-vitro Gluten Challenge
Sponsor:
Beth Israel Deaconess Medical Center
Organization:
Study Overview
Official Title:
An In-vitro Gluten Challenge on the Immunologic Response in Celiac Disease.
Status:
COMPLETED
Status Verified Date:
2018-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
* 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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: