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Assessing Neurocognitive Effects of Gluten Exposure

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ClinicalTrials.gov Identifier: NCT01506349
Recruitment Status : Terminated (enrollment)
First Posted : January 10, 2012
Last Update Posted : March 20, 2018
Sponsor:
Information provided by (Responsible Party):
Daniel Leffler, Beth Israel Deaconess Medical Center

Brief 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.


Condition or disease Intervention/treatment Phase
Celiac Disease Neurobehavioral Manifestations Dietary Supplement: gluten Dietary Supplement: Placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: An Assessment of Neurocognitive Symptoms After Gluten Exposure in Adult Patients With Celiac Disease - a Pilot Study
Actual Study Start Date : June 2015
Actual Primary Completion Date : October 2017
Actual Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Celiac Disease
U.S. FDA Resources

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: gluten
4 grams of gluten.
Dietary Supplement: Placebo
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: gluten
4 grams of gluten.
Dietary Supplement: Placebo



Primary Outcome Measures :
  1. change in neurocognitive measurements [ Time Frame: Baseline, Visit 2 (2 to 6 weeks after baseline), Visit 3 (2 to 6 weeks after Visit 2) ]
    Neurocognitive measurements will be made using the CogState Research computerized tests



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01506349


Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Investigators
Principal Investigator: Daniel A Leffler, MD, MS Beth Israel Deaconess Medical Center

Responsible Party: Daniel Leffler, Associate Professor of Medicine, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT01506349     History of Changes
Other Study ID Numbers: 2011P000354
First Posted: January 10, 2012    Key Record Dates
Last Update Posted: March 20, 2018
Last Verified: March 2018

Keywords provided by Daniel Leffler, 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