NCT01506349

Assessing Neurocognitive Effects of Gluten Exposure

An Assessment of Neurocognitive Symptoms After Gluten Exposure in Adult Patients With Celiac Disease - a Pilot Study

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Beth Israel Deaconess Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

Many patients with celiac disease complain of neurocognitive symptoms such as mental confusion, grogginess, difficulty with concentration and forgetfulness after exposure to gluten. However, there is little data on any possible association between impaired cognitive function and gluten intake in celiac disease. The investigators predict that patients with celiac disease, when exposed to gluten, will experience neurocognitive symptoms such as confusion, forgetfulness and difficulty concentrating. The goals of this study are to determine the prevalence of neurocognitive symptoms after exposure to gluten in patients with celiac disease and to characterize the nature of these symptoms both in terms of their duration and severity.

Conditions

• Celiac Disease
• Neurobehavioral Manifestations

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	gluten	4 grams of gluten.
DIETARY_SUPPLEMENT	Placebo

Timeline

• Start date: 2015-06-01
• Primary completion: 2017-10-01
• Completion: 2018-03-01
• First posted: 2012-01-10
• Last updated: 2018-03-20

Locations

1 site across 1 country: United States