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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)

Sponsor
University of Maryland, Baltimore (Other)
Overall Status
Recruiting
CT.gov ID
NCT03183609
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
96.7
Anticipated Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Gluten Flour in Protein Shake
  • Other: Rice Flour in Protein Shake
 N/A

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized double blind trialRandomized double blind trial
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official 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)
Actual Study Start Date :
Jul 10, 2017
Anticipated Primary Completion Date :
Jul 30, 2022
Anticipated Study Completion Date :
Jul 30, 2025

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Gluten

30 grams of gluten flour daily in protein shake

Other: Gluten Flour in Protein Shake
15 Grams Gluten Flour BID
Placebo Comparator: Placebo

30 grams of rice flour daily in protein shake

Other: Rice Flour in Protein Shake
15 Grams Rice Flour BID

Outcome Measures

Primary Outcome Measures

  1. Negative symptom change as defined by difference in Scale for the Assessment of Negative Symptoms (SANS) score [5 weeks]

    This will be measured by the difference in Scale for the Assessment of Negative Symptoms (SANS) score from baseline to week 5.

Secondary Outcome Measures

  1. Change in cognitive function as measured by change in MATRICS Consensus Cognitive Battery (MCCB) [5 weeks]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 64 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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 Sign Consent.

Exclusion Criteria:

  1. Persons already on gluten free diets

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

  3. Pregnant or lactating females

  4. 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

  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:

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

  2. Current claustrophobia

  3. Inability to lie supine for 1.5 hours

Contacts and Locations

Locations

Site City State Country Postal Code
1 Maryland Psychiatric Research Center (MPRC) Outpatient Research Program (ORP); the MPRC Treatment Research Program (TRP) Catonsville Maryland United States 21228

Sponsors and Collaborators

  • University of Maryland, Baltimore

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Deanna Kelly, Principal Investigator, University of Maryland, Baltimore
ClinicalTrials.gov Identifier:
NCT03183609
Other Study ID Numbers:
  • HP-00075175
First Posted:
Jun 12, 2017
Last Update Posted:
Oct 29, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Schizophrenia
Mood Disorders
Psychotic Disorders

Study Results

No Results Posted as of Oct 29, 2021