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NCT Number: NCT03183609

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)

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.

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Key information

Conditions

Schizophrenia Celiac Disease Digestive System Diseases Gastrointestinal Diseases Gluten Sensitivity Intestinal Diseases Malabsorption Syndromes Mental Disorders Metabolic Diseases Nutritional and Metabolic Diseases Psychotic Disorders Schizo Affective Disorder Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maryland Psychiatric Research Center (MPRC) Outpatient Research Program (ORP); the MPRC Treatment Research Program (TRP)

Catonsville, Maryland, 21228, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gluten Flour in Protein Shake

Other

15 Grams Gluten Flour BID

Rice Flour in Protein Shake

Other

15 Grams Rice Flour BID

Primary outcomes

  1. Negative symptom change as defined by difference in Clinical Assessment of Negative Symptoms -Motivation and Pleasure scale (CAINS-MAP)

    Time frame: 5 weeks

    This will be measured by the difference in Clinical Assessment of Negative Symptoms -Motivation and Pleasure scale CAINS-MAP) score from baseline to week 5, with a lower score yielding a better outcome.

Secondary outcomes

  1. Change in cognitive function as measured by change in MATRICS Consensus Cognitive Battery (MCCB)

    Time frame: 5 weeks

    This will be measured by the difference in MATRICS Consensus Cognitive Battery (MCCB) scores from baseline to week 5

Sponsors and collaborators

Lead sponsor

University of Maryland, Baltimore

Other

Registry information

Official study title

Confirmatory Double-Blind Placebo-Controlled 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)

Important dates

Study start
2017
Primary completion
2024
Study completion
2024
First posted
Jun 12, 2017
Registry last updated
Jun 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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