Back to resultsAssessing Neurocognitive Effects of Gluten Exposure
Primary Purpose
Celiac Disease, Neurobehavioral Manifestations
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
gluten
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Celiac Disease focused on measuring celiac disease, gluten, fog, attention
Eligibility 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.
Sites / Locations
- Beth Israel Deaconess Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Crossover Group 1
Crossover Group 2
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
change in neurocognitive measurements
Neurocognitive measurements will be made using the CogState Research computerized tests
Secondary Outcome Measures
Full Information
NCT ID
NCT01506349
First Posted
October 25, 2011
Last Updated
March 16, 2018
Sponsor
Beth Israel Deaconess Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01506349
Brief Title
Assessing Neurocognitive Effects of Gluten Exposure
Official Title
An Assessment of Neurocognitive Symptoms After Gluten Exposure in Adult Patients With Celiac Disease - a Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Terminated
Why Stopped
enrollment
Study Start Date
June 2015 (Actual)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
March 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beth Israel Deaconess Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Celiac Disease, Neurobehavioral Manifestations
Keywords
celiac disease, gluten, fog, attention
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Crossover Group 1
Arm Type
Experimental
Arm Description
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.
Arm Title
Crossover Group 2
Arm Type
Experimental
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
gluten
Intervention Description
4 grams of gluten.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
change in neurocognitive measurements
Description
Neurocognitive measurements will be made using the CogState Research computerized tests
Time Frame
Baseline, Visit 2 (2 to 6 weeks after baseline), Visit 3 (2 to 6 weeks after Visit 2)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel A Leffler, MD, MS
Organizational Affiliation
Beth Israel Deaconess Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
12. IPD Sharing Statement
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Assessing Neurocognitive Effects of Gluten Exposure
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