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Schizophrenia and the Gut Microbiome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02921243
Recruitment Status : Completed
First Posted : October 3, 2016
Last Update Posted : August 19, 2019
Information provided by (Responsible Party):
Robert Buchanan, University of Maryland, Baltimore

Brief Summary:
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.

Condition or disease
Schizophrenia Schizoaffective Disorder

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Study Type : Observational
Actual Enrollment : 11 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Schizophrenia and the Gut Microbiome
Actual Study Start Date : October 1, 2016
Actual Primary Completion Date : June 18, 2019
Actual Study Completion Date : June 18, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Stool Sample Collection

Primary Outcome Measures :
  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.

Biospecimen Retention:   Samples With DNA
Metatranscriptomics: Metatranscriptomics analyses provide a snapshot of the expressed genes in a sample, which allows for mechanistic insights into the microbiome not possible with 16S rRNA profiling only.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
In-participants with Schizophrenia

Inclusion Criteria:

  1. DSM-IV-TR /DSM 5 diagnosis of schizophrenia or schizoaffective disorder;
  2. Age 18-64 years;
  3. currently hospitalized for at least 7 days
  4. currently treated with an antipsychotic, with no dose changes in last 14 days
  5. 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:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02921243

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United States, Maryland
Maryland Psychiatric Research Center
Catonsville, Maryland, United States, 21228
Sponsors and Collaborators
University of Maryland, Baltimore
Additional Information:
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Responsible Party: Robert Buchanan, Director, Maryland Psychiatric Research Cente, University of Maryland, Baltimore Identifier: NCT02921243    
Other Study ID Numbers: HP-00069555
First Posted: October 3, 2016    Key Record Dates
Last Update Posted: August 19, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders