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NCT03183609 · ClinicalTrials.gov registry record · NA

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)

A NA study of Schizophrenia and Schizo Affective Disorder, sponsored by University of Maryland, Baltimore.

Completed
Registry status
NA
Development phase
40
Enrollment target
1
Study location

NCT03183609 is a NA study of Schizophrenia and Schizo Affective Disorder that has completed, run by University of Maryland, Baltimore. The registered enrollment target is 40 participants, below the 219-participant average among 315 other Schizophrenia trials with a reported enrollment target (82% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT03183609, a NA study of Schizophrenia and Schizo Affective Disorder, has completed, sponsored by University of Maryland, Baltimore.

COMPLETED
Registry status
NA
Development phase
40 participants
Enrollment target
1
Study location

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.

Interventions

  • OTHER Gluten Flour in Protein Shake
  • OTHER Rice Flour in Protein Shake

Study Locations (1)

Maryland

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

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2017-07-10
Est. Completion 2024-03-30
Phase NA

Sponsor

University of Maryland, Baltimore

560 total trials

What the Registry Record Tells You About NCT03183609

The ClinicalTrials.gov registry entry for NCT03183609 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 219-participant average among 315 other Schizophrenia trials with a reported enrollment target (82% lower). The listed sponsor is University of Maryland, Baltimore, which has 560 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Schizophrenia appearing as the primary indexed condition, and to 2 interventions - of which Gluten Flour in Protein Shake is the first listed.

NCT03183609 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.

Frequently Asked Questions

What is clinical trial NCT03183609 about?

NCT03183609 is a clinical study titled "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)". 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...

What is the current status of trial NCT03183609?

This trial is currently completed. It is a NA study. The enrollment target is 40 participants. The study started on 2017-07-10. Estimated completion is 2024-03-30.

What conditions does trial NCT03183609 study?

This clinical trial studies the following conditions: Schizophrenia, Schizo Affective Disorder, Gluten Sensitivity.

What interventions are being tested in trial NCT03183609?

The interventions under investigation include: Gluten Flour in Protein Shake (OTHER), Rice Flour in Protein Shake (OTHER).

Who is sponsoring clinical trial NCT03183609?

This trial is sponsored by University of Maryland, Baltimore, which has 560 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03183609 being conducted?

This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.