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Immune Response in Celiac Disease on In-vitro Gluten Challenge
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Purpose
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 |
|---|
| Celiac Disease |
| Study Type: | Observational |
| Study Design: | Observational Model: Other Time Perspective: Prospective |
| Official Title: | An In-vitro Gluten Challenge on the Immunologic Response in Celiac Disease. |
- change in interferon gamma [ Time Frame: 0, 6, and 24 hours ]in vitro culture stimulated with gluten
- 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
| Estimated Enrollment: | 40 |
| Study Start Date: | February 2013 |
| Estimated Study Completion Date: | December 2018 |
| Estimated Primary Completion Date: | January 2018 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| 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. |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01909050
| United States, Massachusetts | |
| Beth Israel Deaconess Medical Center | |
| Boston, Massachusetts, United States, 02215 | |
| 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 |
| Study First Received: | July 18, 2013 |
| Last Updated: | March 23, 2017 |
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 |
ClinicalTrials.gov processed this record on September 21, 2017