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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)

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ClinicalTrials.gov Identifier: NCT03183609
Recruitment Status : Recruiting
First Posted : June 12, 2017
Last Update Posted : October 19, 2020
Sponsor:
Information provided by (Responsible Party):
Deanna Kelly, University of Maryland, Baltimore

Tracking Information
First Submitted Date  ICMJE June 7, 2017
First Posted Date  ICMJE June 12, 2017
Last Update Posted Date October 19, 2020
Actual Study Start Date  ICMJE July 10, 2017
Estimated Primary Completion Date July 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 8, 2017)
Negative symptom change as defined by difference in Scale for the Assessment of Negative Symptoms (SANS) score [ Time Frame: 5 weeks ]
This will be measured by the difference in Scale for the Assessment of Negative Symptoms (SANS) score from baseline to week 5.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 8, 2017)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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)
Official Title  ICMJE 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)
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomized double blind trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Schizophrenia
  • Gluten Sensitivity
  • Schizo Affective Disorder
Intervention  ICMJE
  • Other: Gluten Flour in Protein Shake
    15 Grams Gluten Flour BID
  • Other: Rice Flour in Protein Shake
    15 Grams Rice Flour BID
Study Arms  ICMJE
  • Active Comparator: Gluten
    30 grams of gluten flour daily in protein shake
    Intervention: Other: Gluten Flour in Protein Shake
  • Placebo Comparator: Placebo
    30 grams of rice flour daily in protein shake
    Intervention: Other: Rice Flour in Protein Shake
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 8, 2017)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 30, 2025
Estimated Primary Completion Date July 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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:

  7. Non-removable ferromagnetic metal on or within the body
  8. Current claustrophobia
  9. Inability to lie supine for 1.5 hours
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ann Keanrs, MS 410-402-6854 akearns@mprc.umaryland.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03183609
Other Study ID Numbers  ICMJE HP-00075175
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Deanna Kelly, University of Maryland, Baltimore
Study Sponsor  ICMJE University of Maryland, Baltimore
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Maryland, Baltimore
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP