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)

NCT03183609 | Completed DMC

• 1 other identifier: HP-00075175
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Schizophrenia; Gluten Sensitivity; Schizo Affective Disorder

Outcome Measures

Primary Outcomes (1)

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

  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.

  5 weeks

Secondary Outcomes (1)

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

  5 weeks

Study Arms (2)

Gluten

ACTIVE COMPARATOR

30 grams of gluten flour daily in protein shake

Other: Gluten Flour in Protein Shake

Placebo

PLACEBO COMPARATOR

30 grams of rice flour daily in protein shake

Other: Rice Flour in Protein Shake

Interventions

Gluten Flour in Protein Shake OTHER

15 Grams Gluten Flour BID

Gluten

Rice Flour in Protein Shake OTHER

15 Grams Rice Flour BID

Placebo

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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
• Non-removable ferromagnetic metal on or within the body
• Current claustrophobia
• Inability to lie supine for 1.5 hours

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

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

Catonsville, Maryland, 21228, United States

Location

Related Publications (1)

• Daniels EC, Eaton WW, Cihakova D, Talor MV, Lemke H, Mo C, Chen S, Notarangelo FM, Rodriguez KM, Kelly DL. The relationship of peripheral inflammation with antibodies to gliadin (AGA IgG) in persons with schizophrenia. Schizophr Res. 2023 Jun;256:50-51. doi: 10.1016/j.schres.2023.02.027. Epub 2023 May 5. No abstract available.

  PMID: 37150147 DERIVED

Related Links

• Maryland Psychiatric Research Center

MeSH Terms

Conditions

Schizophrenia; Celiac Disease; Psychotic Disorders

Interventions

Flour

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized double blind trial

Study Record Dates

• First Submitted: June 7, 2017
• First Posted: June 12, 2017
• Study Start: July 10, 2017
• Primary Completion: March 30, 2024
• Study Completion: March 30, 2024
• Last Updated: June 12, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)