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Schizophrenia and the Gut Microbiome

Sponsor
University of Maryland, Baltimore (Other)
Overall Status
Completed
CT.gov ID
NCT02921243
Collaborator
(none)
11
Enrollment
1
Location
32.5
Actual Duration (Months)
0.3
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    Study Design

    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 :
    Oct 1, 2016
    Actual Primary Completion Date :
    Jun 18, 2019
    Actual Study Completion Date :
    Jun 18, 2019

    Arms and Interventions

    Arm Intervention/Treatment
    Stool Sample Collection
    Prebiotic

    Outcome Measures

    Primary Outcome Measures

    1. 16S rRNA gene amplicons from stool samples [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 64 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Maryland Psychiatric Research Center Catonsville Maryland United States 21228

    Sponsors and Collaborators

    • University of Maryland, Baltimore

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Robert Buchanan, Director, Maryland Psychiatric Research Cente, University of Maryland, Baltimore
    ClinicalTrials.gov Identifier:
    NCT02921243
    Other Study ID Numbers:
    • HP-00069555
    First Posted:
    Oct 3, 2016
    Last Update Posted:
    Aug 19, 2019
    Last Verified:
    Aug 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Schizophrenia
    Psychotic Disorders

    Study Results

    No Results Posted as of Aug 19, 2019