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Tissue Destruction and Healing in Celiac Disease

Primary Purpose

Celiac Disease

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Gluten containing snack bar
Sponsored by
University of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Celiac Disease focused on measuring gluten-free diet, HLA-DQ2, HLA-DQ8, microbiome, metagenomics, intestinal epithelial cells

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Gluten challenge group: Age 18 to 70 years old Diagnosis of Celiac disease for at least 12 months by intestinal biopsy Follow a strict gluten-free diet for at least the 12 consecutive months Gluten de-challenge group: Age 18 to 70 years old Showing typical celiac disease symptoms Not on a gluten-free diet Control group: Age 18 to 70 years old Females who are not pregnant Exclusion Criteria: Gluten challenge group: Diagnosis of any severe complication of celiac disease Diagnosis of other chronic, active GI disease Selective IgA deficiency Severe reaction to gluten exposure Any clinically significant diseases History of significant substance or alcohol abuse Pregnant or lactating Diagnosis of blood clotting disorders Gluten de-challenge group: History of chronic inflammatory gastrointestinal disease Gastrointestinal illness within the 4-week period prior to screening History of lymphoproliferative disease Uncontrolled blood clotting disorders Any clinically significant diseases History of significant substance or alcohol abuse Control group: Taking antibiotics, proton pump inhibitors, aspirin, or non-steroidal anti-inflammatory drugs Known intestinal inflammation Prior gastrointestinal surgery Taking of antiplatelet agents or anticoagulants Family history of celiac disease

Sites / Locations

  • California Institute of Technology
  • The University of ChicagoRecruiting
  • Mayo Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

No Intervention

Arm Label

Gluten challenge group

Gluten de-challenge group

Control group

Arm Description

Diagnosis of celiac disease by intestinal biopsy and serology for at least 12 months

Suspected celiac disease either showing typical symptoms or positive celiac disease serology

No history or symptoms of celiac disease

Outcomes

Primary Outcome Measures

Gluten challenge group: quantitative analysis of intestinal villus to crypt ratios
villus to crypt ratios will be quantified on small bowel biopsy samples for the histologic quantification of intestinal responses to disease processes.
Gluten de-challenge group: quantitative analysis of intestinal villus to crypt ratios
Villus to crypt ratios will be quantified on small bowel biopsy samples for the histologic quantification of intestinal responses to disease processes.

Secondary Outcome Measures

Full Information

First Posted
December 5, 2022
Last Updated
August 8, 2023
Sponsor
University of Chicago
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Mayo Clinic, California Institute of Technology
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1. Study Identification

Unique Protocol Identification Number
NCT05680012
Brief Title
Tissue Destruction and Healing in Celiac Disease
Official Title
Tissue Destruction and Healing in Celiac Disease
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 14, 2023 (Actual)
Primary Completion Date
June 30, 2027 (Anticipated)
Study Completion Date
June 30, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Mayo Clinic, California Institute of Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this clinical study is to learn more about celiac disease pathogenesis and clinical symptoms. In particular, this study will examine the interactions between biological factors such as, intestinal epithelial cells, microbiota, immune system, genetics, and gluten and their effect on celiac disease clinical symptoms, and severity of tissue destruction and its ability to heal in individuals with celiac disease. Information collected in the study will help researchers to generate better resources to advance celiac disease patient care.
Detailed Description
Celiac disease is an autoimmune enteropathy characterized by chronic inflammation of the small intestinal mucosa triggered by gluten uptake that occurs in genetically susceptible individuals carrying the specific class II human leucocyte antigens (HLA) DQ2 and DQ8 alleles. There is a spectrum in intestinal tissue damage associated with celiac disease. Some individuals develop inflammatory immunity in the absence of tissue damage, while others experience tissue damage ranging from partial to total villous atrophy. Persistent mucosal damage is associated with several severe complications, including lymphoproliferative malignancy and bone diseases. In addition, individuals with active celiac disease display a wide range of clinical symptoms, including metabolic defects that are not correlated to the degree of villous atrophy. Although much progress has been made in understanding celiac disease, major gaps remain in understanding biological mechanisms underlying inter-individual differences in clinical presentations and capacity to heal while maintaining a gluten-free diet.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Celiac Disease
Keywords
gluten-free diet, HLA-DQ2, HLA-DQ8, microbiome, metagenomics, intestinal epithelial cells

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
220 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Gluten challenge group
Arm Type
Experimental
Arm Description
Diagnosis of celiac disease by intestinal biopsy and serology for at least 12 months
Arm Title
Gluten de-challenge group
Arm Type
No Intervention
Arm Description
Suspected celiac disease either showing typical symptoms or positive celiac disease serology
Arm Title
Control group
Arm Type
No Intervention
Arm Description
No history or symptoms of celiac disease
Intervention Type
Dietary Supplement
Intervention Name(s)
Gluten containing snack bar
Intervention Description
Ingest snack bars containing 3 grams of gluten every day for 7 weeks.
Primary Outcome Measure Information:
Title
Gluten challenge group: quantitative analysis of intestinal villus to crypt ratios
Description
villus to crypt ratios will be quantified on small bowel biopsy samples for the histologic quantification of intestinal responses to disease processes.
Time Frame
baseline - 6 weeks
Title
Gluten de-challenge group: quantitative analysis of intestinal villus to crypt ratios
Description
Villus to crypt ratios will be quantified on small bowel biopsy samples for the histologic quantification of intestinal responses to disease processes.
Time Frame
baseline -12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Gluten challenge group: Age 18 to 70 years old Diagnosis of Celiac disease for at least 12 months by intestinal biopsy Follow a strict gluten-free diet for at least the 12 consecutive months Gluten de-challenge group: Age 18 to 70 years old Showing typical celiac disease symptoms Not on a gluten-free diet Control group: Age 18 to 70 years old Females who are not pregnant Exclusion Criteria: Gluten challenge group: Diagnosis of any severe complication of celiac disease Diagnosis of other chronic, active GI disease Selective IgA deficiency Severe reaction to gluten exposure Any clinically significant diseases History of significant substance or alcohol abuse Pregnant or lactating Diagnosis of blood clotting disorders Gluten de-challenge group: History of chronic inflammatory gastrointestinal disease Gastrointestinal illness within the 4-week period prior to screening History of lymphoproliferative disease Uncontrolled blood clotting disorders Any clinically significant diseases History of significant substance or alcohol abuse Control group: Taking antibiotics, proton pump inhibitors, aspirin, or non-steroidal anti-inflammatory drugs Known intestinal inflammation Prior gastrointestinal surgery Taking of antiplatelet agents or anticoagulants Family history of celiac disease
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sonia Kupfer, MD
Phone
(773) 834-1438
Email
skupfer@bsd.uchicago.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Kristi Kearney, RN
Phone
773-834-7414
Email
kkearney@bsd.uchicago.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bana Jabri, MD
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
California Institute of Technology
City
Pasadena
State/Province
California
ZIP/Postal Code
91125
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rustem Ismagilov, PhD
Phone
626-395-8130
Email
rustem.admin@caltech.edu
Facility Name
The University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bana Jabri, MD
Email
bjabri@bsd.uchicago.edu
First Name & Middle Initial & Last Name & Degree
Sonia Kupfer, MD
Email
skupfer@bsd.uchicago.edu
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55902
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joseph Murray, MD
Email
Murray.Joseph@mayo.edu
First Name & Middle Initial & Last Name & Degree
Chadrick Hinson
Phone
507-266-0237
Email
Hinson.chadrick@mayo.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Tissue Destruction and Healing in Celiac Disease

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