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Immune Response in Celiac Disease on In-vitro Gluten Challenge

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01909050
Enrollment
42
Registered
2013-07-26
Start date
2013-02-28
Completion date
2018-03-31
Last updated
2018-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Celiac Disease

Keywords

celiac disease, refractory celiac disease, gluten sensitivity

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.

Interventions

None listed

Sponsors

Beth Israel Deaconess Medical Center
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
change in interferon gamma0, 6, and 24 hoursin vitro culture stimulated with gluten

Secondary

MeasureTime frameDescription
change in interleukin-150, 6, and 24 hoursin vitro culture stimulated with gluten
change in interleukin-180, 6, and 24 hoursin vitro culture stimulated with gluten
change in interleukin-210, 6, and 24 hoursin vitro culture stimulated with gluten

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026