Changes in Intestinal Permeability 4 Hours After Gluten Challenge

Completed · Not applicable · Has a placebo group

Conditions studied: Celiac Disease, Wheat Hypersensitivity, Gluten Sensitivity, Gluten Enteropathy, Immune System and Related Disorders, Duodenal Diseases

In brief

This study evaluates why people with celiac disease and non-celiac gluten/wheat sensitivity develop rapid onset symptoms within hours of gluten exposure. Half of subjects will be given gluten and half will not.

Key facts

Study ID

NCT03288831

Run by

Mayo Clinic

People needed

60

Starts

2017-10-10

Expected to finish

2018-10-30

Last updated by the study team

2019-06-07

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

• Tobacco use
• Symptomatic coronary disease
• Active, severe pulmonary disease
• Baseline oxygen requirement
• Coagulopathy (INR>1.5)
• Mastocytosis
• Active H. pylori infection
• Treated celiac disease with neutrophilia or eosinophilia secondary to infection
• Diabetes (type 1 and type 2)
• Crohn's disease or Ulcerative colitis
• Microscopic colitis
• Dermatitis herpetiformis
• Gastroparesis
• Pregnant women
• Subjects exposed to the following medications during their respective time frames will be excluded:
• NSAIDs (24 hours)
• Leukotriene inhibitors (24 hours)
• Mast cell stabilizers (24 hours)
• Benzodiazepines (24 hours)
• H2 blockers (2 days)
• H1 blockers (7 days)
• Steroids (systemic or topically active within gastrointestinal tract) (30 days)
• Topical steroids (14 days)
• Intermittent (up to once weekly) tranquilizer (trazodone, doxepin) use (7 days)
• Chronic tricyclic antidepressant or tranquilizer use (trazodone, doxepin) Use of these medications will also be prohibited during the study duration (AAAAI and AAOA).

Where it is running

• Mayo Clinic — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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