NCT03288831

Changes in Intestinal Permeability 4 Hours After Gluten Challenge

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Detailed description

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.

Conditions

• Celiac Disease
• Wheat Hypersensitivity
• Gluten Sensitivity
• Gluten Enteropathy
• Immune System and Related Disorders
• Duodenal Diseases

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Gluten	Six grams of gluten will be mixed with water and Tang flavoring. Subjects will drink the mixture one time.
DIETARY_SUPPLEMENT	Placebo	Subjects will drink a mixture of rice water and Tang flavoring one time.

Timeline

• Start date: 2017-10-10
• Primary completion: 2018-10-30
• Completion: 2018-10-30
• First posted: 2017-09-20
• Last updated: 2019-06-07

Locations

1 site across 1 country: United States