Assessing Neurocognitive Effects of Gluten Exposure
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.
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|Eligible Ages||18 Years - 50 Years|
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.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
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Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Beth Israel Deaconess Medical Center|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Daniel A Leffler, MD, MS|
|Principal Investigator Affiliation||Beth Israel Deaconess Medical Center|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
|Celiac Disease, Neurobehavioral Manifestations|
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