Assessing Neurocognitive Effects of Gluten Exposure

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

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.

Study Overview

• Status: Terminated
• Conditions: Neurobehavioral Manifestations; Celiac Disease
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: gluten

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male or female
2. 18-50 years of age
3. Celiac Disease Group: Positive small intestinal biopsies meeting Marsh II or III histologic criteria for celiac disease at least six months since the time of study entrance as well as positive IgA anti-tissue transglutaminase antibody or positive IgA/IgG anti-Deamidated Gliadin Peptide (DGP) with normal serum IgA
4. Non-Celiac Gluten Sensitive Group: Negative small intestinal biopsies and negative IgA anti-tissue transglutaminase (tTG) or negative IgA/IgG anti-Deamidated Gliadin Peptide (DGP) with normal serum IgA, but with symptomatic response to gluten withdrawal
5. Subject should have well controlled celiac disease and have been on a gluten-free diet for at least six months prior to study enrollment
6. Subject must provide informed consent, as approved by the Institutional Review Board, and agree to complete required study visits, blood work neuropsychological testing and a urine pregnancy test (if applicable).
7. Subject agrees to use appropriate birth control for the duration of the study.

Exclusion Criteria:

1. Subject has other food intolerances or food allergies (other than gluten) that would interfere with the conduct of the study (e.g. corn starch, soy).
2. Subject has a history of severe, acute symptomatic reactions to sporadic gluten ingestion
3. Subject has any chronic active gastrointestinal disease other than celiac disease (e.g. Crohn's disease, irritable bowel syndrome, autoimmune enteropathy, eosinophilic enteritis).
4. Subject should not have daily symptoms concerning for brain fog such as mental confusion or difficulty concentrating, at baseline.
5. Subject has symptomatic neurological or psychiatric disease(s) that would interfere with the conduct of the study.
6. Subject should not have been on corticosteroids or other immunosuppressive agents in the past 3 months.
7. Significant other co-morbidity as determined by the Principal Investigator
8. Subject is deemed inappropriate by the Principal Investigator.
9. Subject is pregnant or breast-feeding at time of participation.
10. Subject weighs less than 110 pounds.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Crossover Group 1; Group 1 will consume 4 grams of gluten before neurocognitive testing at Visit 2. Group 1 will consume placebo before neurocognitive testing at Visit 3.	Dietary supplement: Placebo; Dietary supplement: gluten; 4 grams of gluten.
Experimental: Crossover Group 2; Group 2 will consume placebo before neurocognitive testing at Visit 2. Group 2 will consume 4 grams of gluten before neurocognitive testing at Visit 3.	Dietary supplement: Placebo; Dietary supplement: gluten; 4 grams of gluten.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in neurocognitive measurements	Neurocognitive measurements will be made using the CogState Research computerized tests	Baseline, Visit 2 (2 to 6 weeks after baseline), Visit 3 (2 to 6 weeks after Visit 2)

Collaborators and Investigators

• Sponsor: Beth Israel Deaconess Medical Center
• Investigators: Principal Investigator: Daniel A Leffler, MD, MS, Beth Israel Deaconess Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2015
• Primary Completion (Actual): October 1, 2017
• Study Completion (Actual): March 1, 2018

Study Registration Dates

• First Submitted: October 25, 2011
• First Submitted That Met QC Criteria: January 9, 2012
• First Posted (Estimate): January 10, 2012

Study Record Updates

• Last Update Posted (Actual): March 20, 2018
• Last Update Submitted That Met QC Criteria: March 16, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: celiac disease; attention; gluten; fog
• Additional Relevant MeSH Terms: Digestive System Diseases; Metabolic Diseases; Nervous System Diseases; Neurologic Manifestations; Gastrointestinal Diseases; Intestinal Diseases; Malabsorption Syndromes; Celiac Disease; Neurobehavioral Manifestations
• Other Study ID Numbers: 2011P000354