Schizophrenia and the Gut Microbiome

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02921243

Enrollment

Registered

2016-10-03

Start date

2016-10-01

Completion date

2019-06-18

Last updated

2019-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizoaffective Disorder, Schizophrenia

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 64 Years

Healthy volunteers

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).

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Outcome results