Assessing Neurocognitive Effects of Gluten Exposure

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT01506349
First received: October 25, 2011
Last updated: December 7, 2015
Last verified: December 2015
  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: Allocation: Randomized
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:


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: June 2015
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  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: December 7, 2015
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
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Malabsorption Syndromes
Metabolic Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on February 07, 2016