Assessing Neurocognitive Effects of Gluten Exposure



Status:Terminated
Conditions:Psychiatric, Endocrine
Therapuetic Areas:Endocrinology, Psychiatry / Psychology
Healthy:No
Age Range:18 - 50
Updated:4/17/2018
Start Date:June 2015
End Date:March 2018

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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.


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.
We found this trial at
1
site
330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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from
Boston, MA
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