Tissue Destruction and Healing in Celiac Disease

Celiac Disease Clinical Trial

Official title:

Tissue Destruction and Healing in Celiac Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05680012
• Other study ID #: IRB22-1138
• Secondary ID: RC2DK133947
• Status: Recruiting
• Phase: N/A
• Start date: July 14, 2023
• Est. completion date: June 30, 2027

Study information

• Verified date: December 2023
• Source: University of Chicago
• Contact: Sonia Kupfer, MD
• Phone: (773) 834-1438
• Email: skupfer[@]bsd.uchicago.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: June 30, 2027
• Est. primary completion date: June 30, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

Gluten challenge group:

1. Age 18 to 70 years old

2. Diagnosis of Celiac disease for at least 12 months by intestinal biopsy

3. Follow a strict gluten-free diet for at least the 12 consecutive months

Gluten de-challenge group:

1. Age 18 to 70 years old

2. Showing typical celiac disease symptoms

3. Not on a gluten-free diet

Control group:

1. Age 18 to 70 years old

2. Females who are not pregnant

Exclusion Criteria:

Gluten challenge group:

1. Diagnosis of any severe complication of celiac disease

2. Diagnosis of other chronic, active GI disease

3. Selective IgA deficiency

4. Severe reaction to gluten exposure

5. Any clinically significant diseases

6. History of significant substance or alcohol abuse

7. Pregnant or lactating

8. Diagnosis of blood clotting disorders

Gluten de-challenge group:

1. History of chronic inflammatory gastrointestinal disease

2. Gastrointestinal illness within the 4-week period prior to screening

3. History of lymphoproliferative disease

4. Uncontrolled blood clotting disorders

5. Any clinically significant diseases

6. History of significant substance or alcohol abuse

Control group:

1. Taking antibiotics, proton pump inhibitors, aspirin, or non-steroidal anti-inflammatory drugs

2. Known intestinal inflammation

3. Prior gastrointestinal surgery

4. Taking of antiplatelet agents or anticoagulants

5. Family history of celiac disease

Related Conditions & MeSH terms

• Celiac Disease

Intervention

Dietary Supplement:
• Gluten containing snack bar
Ingest snack bars containing 3 grams of gluten every day for 7 weeks.

Locations

Country	Name	City	State
United States	The University of Chicago	Chicago	Illinois
United States	California Institute of Technology	Pasadena	California
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (4)

Lead Sponsor	Collaborator
University of Chicago	California Institute of Technology, Mayo Clinic, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	baseline - 6 weeks
Primary	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.	baseline -12 months