Prebiotic Treatment in People With Schizophrenia - Pilot Study

Completed · Phase 4 · Has a placebo group

Conditions studied: Schizophrenia, Schizoaffective Disorder

In brief

The purpose of this study is to examine changes in serum butyrate levels with the prebiotic: Prebiotin (12g/day), an oligofructose-enriched inulin (OEI); the effect of OEI on the composition of the gastrointestinal microbiota in people with schizophrenia; and the relationship of the composition of the gut microbiota to various clinical, cognitive, and neuroimaging variables.

Key facts

Study ID

NCT03617783

Run by

University of Maryland, Baltimore

People needed

26

Starts

2019-07-18

Expected to finish

2022-04-05

Last updated by the study team

2023-06-15

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• DSM-IV-TR /DSM 5 diagnosis of schizophrenia or schizoaffective disorder;
• Age 18-60 years
• Clinically stable as determined by opinion of treating clinician
• 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.
• BMI ≤ 35

You may not qualify if…

• Gastrointestinal disorders, including, but not limited to Crohn's Disease, Irritable Bowel Syndrome, Celiac Disease, whose pathology or treatment could alter the presentation or treatment of schizophrenia or significantly increase the risk associated with the proposed treatment protocol
• Organic brain disorder, including cerebrovascular accident; epilepsy; traumatic brain injury, Loss of consciousness (LOC) for more than 30 minutes
• Intellectual disability
• 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
• Pregnant or lactating women secondary to pregnancy
• Meet DSM-5 criteria for alcohol or substance use disorders (except Tobacco Use Disorder) within last 3 months

Where it is running

• Maryland Psychiatric Research Center (MPRC) Treatment Research Program (TRP) — Catonsville, Maryland, United States

Full record on ClinicalTrials.gov

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