FARE Clinical Trial Finder

Simplify your search for a clinical trial and help researchers discover new therapies. The FARE Clinical Trial Finder links patients with food allergy and healthy, non-patient volunteers to actively recruiting food allergy studies.

Changes in Intestinal Permeability 4 Hours After Gluten Challenge

Study Purpose

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.

Recruitment Criteria

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Accepts Healthy Volunteers
Yes

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Study Type
Interventional
Eligible Ages 18 Years - 70 Years
Gender All
More Inclusion & Exclusion Criteria

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).

Trial Details

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

Trial ID:
NCT03288831

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase
N/A

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Lead Sponsor
Mayo Clinic

The person who is responsible for the scientific and technical direction of the entire clinical study.

Principal Investigator
Joseph A. Murray, M.D.
Principal Investigator Affiliation Mayo Clinic

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Agency Class
Other
Overall Status Enrolling by invitation
Countries United States

The disease, disorder, syndrome, illness, or injury that is being studied.

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

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 without celiac disease develop similar symptoms when they eat gluten or wheat. Doctors and scientists do not know what causes this sensitivity to gluten. People with celiac disease and non-celiac gluten sensitivity report symptoms within hours of being exposed to gluten. This study evaluates why this occurs by looking at changes in blood, urine, stool, and the bowel after being given gluten.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Mayo Clinic, Rochester, Minnesota

Status

Address

Mayo Clinic

Rochester, Minnesota, 55905

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