Assessing Neurocognitive Effects of Gluten Exposure

NCT01506349 | Terminated

• 1 other identifier: 2011P000354
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Celiac Disease; Neurobehavioral Manifestations

Keywords

celiac disease; gluten; fog; attention

Outcome Measures

Primary Outcomes (1)

• change in neurocognitive measurements

  Neurocognitive measurements will be made using the CogState Research computerized tests

  Baseline, Visit 2 (2 to 6 weeks after baseline), Visit 3 (2 to 6 weeks after Visit 2)

Study Arms (2)

Crossover Group 1

EXPERIMENTAL

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; Dietary Supplement: Placebo

Crossover Group 2

EXPERIMENTAL

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; Dietary Supplement: Placebo

Interventions

gluten DIETARY_SUPPLEMENT

4 grams of gluten.

Crossover Group 1; Crossover Group 2

Placebo DIETARY_SUPPLEMENT

Crossover Group 1; Crossover Group 2

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Celiac Disease; Neurobehavioral Manifestations

Interventions

Glutens

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prolamins; Grain Proteins; Plant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Seed Storage Proteins

Study Officials

• Daniel A Leffler, MD, MS

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: October 25, 2011
• First Posted: January 10, 2012
• Study Start: June 1, 2015
• Primary Completion: October 1, 2017
• Study Completion: March 1, 2018
• Last Updated: March 20, 2018

Record last verified: 2018-03

Locations

US (1)