Intracellular Tight Junction Permeability in Schizophrenia: Focus on Zonulin

The purpose of this protocol is to collect serum zonulin levels in people with schizophrenia. This one time visit will collect zonulin levels, antibodies to gliadin (tissue transglutaminase and antigliadin antibodies) and other information that may relate to increased intracellular tight junction permeability as it related to the immune and stress system and the immune association with kynurenic acid pathway 50. Data will be collected for use in future grant applications and published reports.

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Maryland Psychiatric Research Center

Catonsville, Maryland, 21228, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

DSM-IV Diagnosis of Schizophrenia or Schizoaffective Disorder
Male or females between ages of 18 to 75 years

Exclusion criteria

Score below 10/12 on the Evaluation to Sign Consent (ESC)

Treatment and study plan

Blood draw

Procedure

One time blood draw

Primary outcomes

Zonulin concentration in serum (ng/mg)

Time frame: 1 day

Participants will undergo a one-time blood draw in order to test for zonulin concentration in serum (ng/mg) and these results will be compared to normative data to screen for elevations. The sample size for this pilot study was estimated based on the known prevalence of Celiac disease in schizophrenia, a disease known to have elevated zonulin levels.

Sponsors and collaborators

Lead sponsor

University of Maryland, Baltimore

Other

Collaborators

University of Maryland, College Park

Registry information

Important dates

Study start: 2011
Primary completion: 2012
Study completion: 2012
First posted: Mar 20, 2012
Registry last updated: Sep 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed