Health TrialsbyHealthPanel

Tissue Destruction and Healing in Celiac Disease

ConditionCeliac Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversity of Chicago

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age 18 to 75 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

Age 18 to 75 years old

Disqualifiers

Diagnosis of any severe complication of celiac disease

Diagnosis of other chronic, active GI disease

Selective IgA deficiency

Severe reaction to gluten exposure

Trial design

Design model

Parallel

Treatments tested in this trial

  • Gluten containing snack bar

    Dietary supplement

    Ingest snack bars containing 3 grams of gluten every day for 6 weeks.

Treatment groups

220 Participants
are divided into 3 treatment groups
Group A: Gluten challenge groupExperimental treatment 1 intervention
Group B: Gluten de-challenge groupNo intervention 0 interventions
Group C: Control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
baseline - 6 weeks
2

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.

Time frame
baseline -12 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Chicago

Lead sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Mayo Clinic

Collaborator

California Institute of Technology

Collaborator

Source ClinicalTrials.gov
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