Mayo Clinic
Rochester, Minnesota, 55905, United States
NCT Number: NCT03288831
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.
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Notify Me18 year–70 year
All sexes
Interventional
Not applicable
Rochester, Minnesota, 55905, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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:
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.
Time frame: 4 hours
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: Baseline and up to eight hours after gluten or placebo exposure
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 72 hours after gluten or placebo exposure
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
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.
Mayo Clinic
Other
The Innate Response to and Changes in Intestinal Permeability 4 Hours After a Gluten Challenge in Subjects With Celiac Disease and Non Celiac Gluten Sensitivity
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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