Immune Response in Celiac Disease on In-vitro Gluten Challenge

NCT01909050 | Completed

• 1 other identifier: 2012P000354
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Celiac Disease

Keywords

celiac disease; refractory celiac disease; gluten sensitivity

Outcome Measures

Primary Outcomes (1)

• change in interferon gamma

  in vitro culture stimulated with gluten

  0, 6, and 24 hours

Secondary Outcomes (3)

• change in interleukin-15

  0, 6, and 24 hours

• change in interleukin-18

  0, 6, and 24 hours

• change in interleukin-21

  0, 6, and 24 hours

Study Arms (5)

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.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects will be selected from patients undergoing a clinically indicated upper endoscopy at Beth Israel Deaconess Medical Center

You may qualify if:

• years of age
• Undergoing a clinically indicated upper endoscopy

You may not qualify if:

• Anticoagulation or antiplatelet therapy
• Known active non-celiac intestinal inflammatory disorder

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Duodenal biopsy samples

MeSH Terms

Conditions

Celiac Disease

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Daniel A Leffler, MD, MS

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: July 18, 2013
• First Posted: July 26, 2013
• Study Start: February 1, 2013
• Primary Completion: January 1, 2018
• Study Completion: March 1, 2018
• Last Updated: March 19, 2018

Record last verified: 2018-03

Locations

US (1)