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)

  • STATUS
    Recruiting
  • End date
    Jul 30, 2025
  • participants needed
    40
  • sponsor
    University of Maryland, Baltimore
Updated on 4 November 2021
antipsychotics
schizophrenia
cognitive symptoms
schizoaffective disorder

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.

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.

Details
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

Eligibility

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note