Changes in Intestinal Permeability 4 Hours After Gluten Challenge (NCT03288831) | Clinical Trial Compass
CompletedNot Applicable
Changes in Intestinal Permeability 4 Hours After Gluten Challenge
United States60 participantsStarted 2017-10-10
Plain-language 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 will not.
Who can participate
Age range18 Years – 70 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 oxy…
What they're measuring
1
Activation of the Mucosal Innate Immune System after Oral Gluten Challenge