An interventional study of Gluten and Placebo in Celiac Disease, Wheat Hypersensitivity and Gluten Sensitivity, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-06-07.
Sponsored by Mayo Clinic · Not applicable, Interventional, and Other
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.
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.
352 studies on the registry are indexed under Celiac Disease; 77 are open to participants now.
This study's enrollment of 60 is above the median of 50 across 214 interventional studies indexed under Celiac Disease.
Browse Celiac Disease studies →Mayo Clinic is the lead sponsor of 3,269 studies on the registry; 672 are open to participants now.
Of its 452 completed or terminated interventional studies of FDA-regulated products, 321 (71%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Inclusion Criteria for subjects with Celiac Disease:
Inclusion Criteria for subjects with Non-Celiac Gluten Sensitivity:
Inclusion Criteria for Normal Subjects:
Exclusion Criteria:
Subjects exposed to the following medications during their respective time frames will be excluded:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Normal subjects will drink a solution containing 6 grams of gluten one time.
Dietary Supplement: Gluten
Normal subjects will drink a solution without gluten one time.
Dietary Supplement: Placebo
Subjects with celiac disease will drink a solution containing 6 grams of gluten one time.
Dietary Supplement: Gluten
Subjects with celiac disease will drink a solution without gluten one time.
Dietary Supplement: Placebo
Subjects with non-celiac gluten sensitivity will drink a solution containing 6 grams of gluten one time.
Dietary Supplement: Gluten
Subjects with non-celiac gluten sensitivity will drink a solution without gluten one time.
Dietary Supplement: Placebo
Six grams of gluten will be mixed with water and Tang flavoring. Subjects will drink the mixture one time.
Subjects will drink a mixture of rice water and Tang flavoring one time.
Activation of the Mucosal Innate Immune System after Oral Gluten Challenge
Small bowel biopsies will be assessed for markers of innate immune system activation: presence of granulocytes, granulocyte degranulation, products of degranulation, interleukins and cytokines involved in the innate immune system response, inflammatory mediators.
Time frame: 4 hours
Changes in Mucosal Permeability after Oral Gluten Challenge
Mucosal permeability will be measure before and after oral gluten or placebo challenge with C13-mannitol lactulose urinary excretion testing. In addition, mucosal permeability will also be measured along the duodenum with a mucosal impedance probe.
Time frame: Baseline and up to eight hours after gluten or placebo exposure
Detection of Gluten Peptides in Urine and Stool
Urine and stool samples will be assessed for the presence of gluten peptides. This will help assess how long these tests are positive after a known gluten exposure.
Time frame: Baseline and up to 72 hours after gluten or placebo exposure
Rapid Onset Symptom Development after Gluten Exposure
Subjects will record the symptoms they experience after gluten or placebo exposure. The will complete a simple symptom diary every 30 minutes for the first 2 hours.
Time frame: Baseline and up to 72 hours after gluten or placebo exposure
Plan to share: No
This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Glutens