Skip to main content
OpenTrials
Completed

NCT Number: NCT01909050

Immune Response in Celiac Disease on In-vitro Gluten Challenge

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Celiac Disease Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Malabsorption Syndromes Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. change in interferon gamma

    Time frame: 0, 6, and 24 hours

    in vitro culture stimulated with gluten

Secondary outcomes

  1. change in interleukin-15

    Time frame: 0, 6, and 24 hours

    in vitro culture stimulated with gluten

  2. change in interleukin-18

    Time frame: 0, 6, and 24 hours

    in vitro culture stimulated with gluten

  3. change in interleukin-21

    Time frame: 0, 6, and 24 hours

    in vitro culture stimulated with gluten

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Jul 26, 2013
Registry last updated
Mar 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.