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)

Last updated: October 2, 2024
Sponsor: University of Maryland, Baltimore
Overall Status: Completed

Phase

N/A

Condition

Affective Disorders

Schizophrenia And Schizoaffective Disorders (Pediatric)

Tourette's Syndrome

Treatment

Gluten Flour in Protein Shake

Rice Flour in Protein Shake

Clinical Study ID

NCT03183609
HP-00075175
  • Ages 18-64
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. DSM-IV/DSM 5 diagnosis of schizophrenia or schizoaffective disorder

  2. Positive for antibodies to gliadin (IgG > 20 U)

  3. SANS total score ≥ 20 and the affective flattening or alogia global item ≥ 3

  4. Age 18- 64 years

  5. Same antipsychotic for at least 4 weeks

  6. Ability to consent determined by a score of 10 or greater on the Evaluation to SignConsent.

Exclusion

Exclusion Criteria:

  1. Persons already on gluten free diets

  2. Positivity to tissue transglutaminase (tTg) antibodies or known history of CeliacDisease

  3. Pregnant or lactating females

  4. Medical condition whose pathology or treatment could alter the presentation ortreatment of schizophrenia or significantly increase the risk associated with theproposed treatment protocol

  5. Meets DSM-5 criteria for alcohol or substance use disorder (other than nicotine)within the last month

  6. Gluten ataxia, as measured by the Brief Ataxia Rating Scale Additional exclusion for those participating in optional imaging component:

  7. Non-removable ferromagnetic metal on or within the body

  8. Current claustrophobia

  9. Inability to lie supine for 1.5 hours

Study Design

Total Participants: 40
Treatment Group(s): 2
Primary Treatment: Gluten Flour in Protein Shake
Phase:
Study Start date:
July 10, 2017
Estimated Completion Date:
March 30, 2024

Study Description

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.

Connect with a study center

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

    Catonsville, Maryland 21228
    United States

    Site Not Available

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