Confirmatory Efficacy Trial of a Gluten-Free Diet in a Subgroup of Persons With Schizophrenia Who Have High Levels of IgG Anti-Gliadin Antibodies (AGA IG)

  • End date
    Jul 30, 2025
  • participants needed
  • sponsor
    University of Maryland, Baltimore
Updated on 4 November 2021
cognitive symptoms
schizoaffective disorder


This study purpose is to conduct a confirmatory double-blind randomized controlled trial in an inpatient setting of the effects of a tightly controlled gluten-free diet (GFD) to improve negative symptoms in people with schizophrenia or schizoaffective disorder who have antibodies to gliadin (AGA IgG). As part of the project investigators will also confirm outcomes such as cognitive symptoms, changes in peripheral and central inflammation as well as gut/blood brain barrier permeability.


This study is a randomized double blind clinical trial being funded by NIMH. Investigators will need to enroll 40 cases with AGA IgG positivity in order to present a powered and convincing result about the efficacy of gluten withdrawal in the subpopulation of persons with schizophrenia with elevated AGA IgG levels. Investigators will recruit a minimum 50 to ensure they are well powered without question, and to account for dropouts. Investigators will use a battery of measures of peripheral and central inflammation as well as gut permeability at baseline and endpoint to confirm the relationship of these outcomes to changes in AGA IgG and symptom changes in the clinical trial. Investigators will test negative symptoms as a primary outcome but will test changes in other symptom domains such as positive symptoms. After the completion of the 5 week confirmatory study, investigators will discharge participants and follow them for 8 weeks in their own environment to test the maintenance of the effect following the stringent GFD, and provide education on gluten free shopping, cooking and eating.

Condition Schizophrenia, schizoaffective disorder, Psychosis, Schizophrenia and Schizoaffective Disorders (Pediatric), Schizophrenia and Schizoaffective Disorders, Gluten Sensitivity, schizophrenia disorders
Treatment Gluten Flour in Protein Shake, Rice Flour in Protein Shake
Clinical Study IdentifierNCT03183609
SponsorUniversity of Maryland, Baltimore
Last Modified on4 November 2021


Yes No Not Sure

Inclusion Criteria

DSM-IV/DSM 5 diagnosis of schizophrenia or schizoaffective disorder
Positive for antibodies to gliadin (IgG > 20 U)
SANS total score 20 and the affective flattening or alogia global item 3
Age 18- 64 years
Same antipsychotic for at least 4 weeks
Ability to consent determined by a score of 10 or greater on the Evaluation to Sign Consent

Exclusion Criteria

Persons already on gluten free diets
Positivity to tissue transglutaminase (tTg) antibodies or known history of Celiac Disease
Pregnant or lactating females
Medical condition whose pathology or treatment could alter the presentation or treatment of schizophrenia or significantly increase the risk associated with the proposed treatment protocol
Meets DSM-5 criteria for alcohol or substance use disorder (other than nicotine) within the last month
Gluten ataxia, as measured by the Brief Ataxia Rating Scale
Additional exclusion for those participating in optional imaging component
\. Non-removable ferromagnetic metal on or within the body
\. Current claustrophobia
\. Inability to lie supine for 1.5 hours
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