Status:
COMPLETED
Changes in Intestinal Permeability 4 Hours After Gluten Challenge
Lead Sponsor:
Mayo Clinic
Conditions:
Celiac Disease
Wheat Hypersensitivity
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
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...
Detailed Description
When a person with celiac disease is exposed to gluten, their immune system attacks their bowel and causes abdominal pain, bloating, and diarrhea. This process takes 24-72 hours to occur. Some people ...
Eligibility Criteria
Inclusion
- Inclusion Criteria for subjects with Celiac Disease:
- Biopsy proven celiac disease diagnosed at least 2 years prior to recruitment
- Attest to following a gluten free diet to the best of their ability
- Quiescent symptoms on a gluten free diet
- Negative tissue transglutaminase at time of recruitment (to be collected with baseline blood work)
- A prior endoscopy with small bowel biopsies reviewed by a gastrointestinal pathologist revealing healing
- Inclusion Criteria for subjects with Non-Celiac Gluten Sensitivity:
- Meet diagnostic consensus criteria as defined by Ludvigsson et al in "The Oslo definitions for coeliac disease and related terms"
- Attest to following a gluten free diet to the best of their ability
- Quiescent symptoms on a gluten free diet
- Prior negative evaluation for celiac disease (including tissue transglutaminase IgA with total IgA or small bowel biopsies)
- If subjects have had a small bowel biopsies revealing increased intraepithelial lymphocytes (IELs), they will be reviewed as a separate subgroup
- Inclusion Criteria for Normal Subjects:
- No gastrointestinal diagnosis (reflux, eosinophilic esophagitis, inflammatory bowel disease, or irritable bowel syndrome)
- No gastrointestinal symptoms (diarrhea, abdominal pain, nausea, vomiting, weight loss)
- No family history of celiac disease
- Will not be required to have a baseline biopsy
- Exclusion Criteria:
- 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).
Exclusion
Key Trial Info
Start Date :
October 10 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 30 2018
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03288831
Start Date
October 10 2017
End Date
October 30 2018
Last Update
June 7 2019
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905