A Study of the Response to and Changes in Intestinal Permeability 4 hours after a Gluten Challenge in Subjects with Celiac Disease and Non Celiac Gluten Sensitivity


About this study

The purpose of this study is to identify mediators—innate immune system and intestinal permeability—of acute onset gastrointestinal symptoms after gluten ingestion in subjects with celiac disease and non-celiac gluten sensitivity.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

Subjects in the celiac disease group (n=20) must have the following:

  • 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

Subjects with non-gluten celiac gluten sensitivity (n=20) must have the following:

  • 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
  • Subjects interested in participating but without prior clinical evaluation to exclude celiac disease will be given the option of Celiac Disease HLA Gene Typing. They will undergo a venipuncture (6 mL in tube ACD/Yel 6 to be sent to CCL lab without processing) for Celiac Disease HLA Gene Typing. If the HLA gene type returns permissive for celiac disease, then celiac disease has not been excluded, and they cannot participate as a NCGS subject in the gluten challenge. However, if HLA gene type returns negative, they can participate as a NCGS subject in the gluten challenge.

Normal control subjects must have the following:

  • 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:

  • 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

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Joseph Murray, M.D.

Closed for enrollment

Contact information:

Carol Van Dyke CCRP



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