Assessing Neurocognitive Effects of Gluten Exposure

This study is currently recruiting participants.

Verified February 2013 by Beth Israel Deaconess Medical Center

Sponsor:

Information provided by (Responsible Party):

Beth Israel Deaconess Medical Center

ClinicalTrials.gov Identifier:

NCT01506349

First received: October 25, 2011

Last updated: February 18, 2013

Last verified: February 2013

History of Changes

Purpose

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.

Condition	Intervention
Celiac Disease Neurobehavioral Manifestations	Dietary Supplement: gluten Dietary Supplement: Placebo

Study Type:	Interventional
Study Design:	Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Basic Science
Official Title:	An Assessment of Neurocognitive Symptoms After Gluten Exposure in Adult Patients With Celiac Disease - a Pilot Study

Resource links provided by NLM:

Genetics Home Reference related topics: celiac disease

MedlinePlus related topics: Celiac Disease

U.S. FDA Resources

Further study details as provided by Beth Israel Deaconess Medical Center:

Primary Outcome Measures:

change in neurocognitive measurements [ Time Frame: Baseline, Visit 2 (2 to 6 weeks after baseline), Visit 3 (2 to 6 weeks after Visit 2) ] [ Designated as safety issue: No ]
Neurocognitive measurements will be made using the CogState Research computerized tests

Estimated Enrollment:	60
Study Start Date:	March 2012
Estimated Primary Completion Date:	December 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Single randomized crossover arm All subjects will be randomized to consume either 4 grams of gluten or placebo before neurocognitive testing at Visit 2. At Visit 2 subjects will cross over and receive the other intervention.	Dietary Supplement: gluten 4 grams of gluten. Dietary Supplement: Placebo

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or female
18-50 years of age
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
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
Subject should have well controlled celiac disease and have been on a gluten-free diet for at least six months prior to study enrollment
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).
Subject agrees to use appropriate birth control for the duration of the study.

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01506349

Contacts

Contact: Joshua Hansen, MS	617-667-8397	jhansen@bidmc.harvard.edu
Contact: Rupa Mukherjee, MD	617-667-8266	rmukherj@bidmc.harvard.edu

Locations

United States, Massachusetts
Beth Israel Deaconess Medical Center	Recruiting
Boston, Massachusetts, United States, 02215
Contact: Joshua Hansen, MS 617-667-8397 jhansen@bidmc.harvard.edu
Principal Investigator: Daniel Leffler, MD, MS

Sponsors and Collaborators

Beth Israel Deaconess Medical Center

More Information

No publications provided

Responsible Party:	Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:	NCT01506349 History of Changes
Other Study ID Numbers:	2011-P-000354
Study First Received:	October 25, 2011
Last Updated:	February 18, 2013
Health Authority:	United States: Institutional Review Board

Keywords provided by Beth Israel Deaconess Medical Center:

celiac disease
gluten
fog
attention

Additional relevant MeSH terms:

Celiac Disease
Neurobehavioral Manifestations
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases

Digestive System Diseases
Metabolic Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013

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