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Completed

NCT Number: NCT02921243

Schizophrenia and the Gut Microbiome

In a sample of 20 inpatients with a DSM-IV-TR/DSM 5 diagnosis of schizophrenia or schizoaffective disorder, investigators propose to conduct a prospective, 2 week observational trial to collect gastrointestinal stool samples in order to characterize the microbiota in people with schizophrenia and examine its variability over time. Participants may elect to participate for an additional two weeks, during which they will receive the prebiotic, oligofructose-enriched inulin (FOS), in order to examine its effects on the relative preponderance of butyrate-producing bacteria in the gut microbiome. Investigators will use an inpatient sample in order to standardize meals, exercise and environmental mediators. This is considered a feasibility, pilot study in order to apply for future grant funding. Investigators will recruit patients from the Treatment Research Program inpatient unit, Maryland Psychiatric Research Center, University of Maryland School of Medicine.

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Key information

Conditions

Schizophrenia Mental Disorders Psychotic Disorders Schizoaffective Disorder Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–64 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-TR /DSM 5 diagnosis of schizophrenia or schizoaffective disorder;
  • Age 18-64 years;
  • currently hospitalized for at least 7 days
  • currently treated with an antipsychotic, with no dose changes in last 14 days
  • ability to participate in the informed consent process, as determined by a score of 10 or greater on the Evaluation to Sign Consent

Exclusion criteria

  • Gastrointestinal disorders, including, but not limited to Crohn's Disease, Irritable Bowel Syndrome, Celiac Disease,
  • Organic brain disorder, including cerebrovascular accident; epilepsy; traumatic brain injury, Loss of consciousness (LOC) for more than 30 minutes
  • Mental retardation
  • Antibiotic or immune therapy within the last three months
  • Prebiotic or probiotic treatment within the last three months
  • Inability to understand English
  • Inability to cooperate with study procedures
  • Pregnant women
  • Prisoner status
  • For MRI ONLY Contraindication for MRI scanning (e.g. metal in body, pacemaker).

Treatment and study plan

Primary outcomes

  1. 16S rRNA gene amplicons from stool samples

    Time frame: 4 weeks

    The 16S rRNA gene amplicon data will be used to examine the relative preponderance of butyrate-producing bacteria in the gut microbiota of people with schizophrenia.

Sponsors and collaborators

Lead sponsor

University of Maryland, Baltimore

Other

Registry information

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Oct 3, 2016
Registry last updated
Aug 19, 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.

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