Viewing Study NCT02921243



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Last Modification Date: 2024-10-26 @ 12:11 PM
Study NCT ID: NCT02921243
Status: COMPLETED
Last Update Posted: 2019-08-19
First Post: 2016-09-27

Brief Title: Schizophrenia and the Gut Microbiome
Sponsor: University of Maryland Baltimore
Organization: University of Maryland Baltimore

Study Overview

Official Title: Schizophrenia and the Gut Microbiome
Status: COMPLETED
Status Verified Date: 2019-08
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: In a sample of 20 inpatients with a DSM-IV-TRDSM 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
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None