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ClinicalTrials.gov Identifier: NCT02921243
Recruitment Status :
First Posted : October 3, 2016
Last Update Posted : August 19, 2019
University of Maryland, Baltimore
Information provided by (Responsible Party):
Robert Buchanan, University of Maryland, Baltimore
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.
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.
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Layout table for eligibility information
Ages Eligible for Study:
18 Years to 64 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
In-participants with Schizophrenia
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
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
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
For MRI ONLY Contraindication for MRI scanning (e.g. metal in body, pacemaker).