Prebiotic Treatment in People With Schizophrenia

Last updated: September 15, 2025
Sponsor: University of Maryland, Baltimore
Overall Status: Active - Recruiting

Phase

N/A

Condition

Tourette's Syndrome

Mood Disorders

Psychosis

Treatment

Prebiotic

Placebo Prebiotic

Clinical Study ID

NCT05527210
HP-00102648
R61AT009990
  • Ages 18-60
  • All Genders

Study Summary

The proposed project is based on the observation that schizophrenia is characterized by a chronic pro-inflammatory state, which contributes to the severity of a number of the clinical manifestations of the illness, including cognitive impairments, the treatment of which represents a critically important unmet therapeutic need.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. DSM-5 diagnosis of schizophrenia or schizoaffective disorder;

  2. Age 18-60 years;

  3. Considered clinically stable by the treating psychiatrist;

  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;

  6. BMI ≤ 40

Exclusion

Exclusion Criteria:

  1. Gastrointestinal disorders, including, but not limited to Crohn's Disease, IrritableBowel Syndrome, Celiac Disease, whose pathology or treatment could alter thepresentation or treatment of schizophrenia or significantly increase the riskassociated with the proposed treatment protocol

  2. Organic brain disorder, including cerebrovascular accident; epilepsy; traumaticbrain injury, Loss of consciousness (LOC) for more than 30 minutes

  3. Intellectual disability

  4. Acute antibiotic use

  5. Immune therapy within the last three months

  6. Prebiotic or probiotic treatment within the last three months

  7. Inability to understand English

  8. Inability to cooperate with study procedures

  9. Pregnant or lactation secondary to pregnancy

  10. Participants who meet DSM 5 criteria for alcohol or substance misuse (exceptcaffeine and nicotine) within the last 3 months will be excluded. Participants whomeet DSM 5 criteria for marijuana misuse - mild will be included in the study.

Study Design

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: Prebiotic
Phase:
Study Start date:
January 25, 2023
Estimated Completion Date:
January 31, 2026

Study Description

The investigators hypothesize that the level of inflammation in people with schizophrenia can be reduced through the use of the prebiotic: Prebiotin®, an oligofructose-enriched inulin (OEI), to stimulate the activity of butyrate-producing bacteria and increase the production of butyrate, which has multiple anti-inflammatory properties. The investigators will confirm the effect of prebiotic administration on the biological signature and examine whether increased serum butyrate levels are associated with changes in cognitive performance (primary specific aim), symptoms, and metabolic measures; and the extent to which these associations are mediated by the anti-inflammatory properties of butyrate, including the ability of butyrate to decrease gut permeability and inhibit the production of pro-inflammatory cytokines, and/or changes in gut microbiota composition.

In a sample of participants with a DSM-5 diagnosis of schizophrenia or schizoaffective disorder, the investigators will conduct a 12-week, double-blind, placebo-controlled, randomized clinical trial to confirm the effect of prebiotic administration on the biological signature and examine whether increased serum butyrate levels are associated with changes in cognitive performance, symptoms, and metabolic measures; and the extent to which these associations are mediated by the anti-inflammatory properties of butyrate, including the ability of butyrate to decrease gut permeability and inhibit the production of pro-inflammatory cytokines, and/or changes in gut microbiota composition.

Connect with a study center

  • Maryland Psyciatric Research Center

    Catonsville, Maryland 21228
    United States

    Site Not Available

  • Maryland Psyciatric Research Center

    Catonsville 4350635, Maryland 4361885 21228
    United States

    Active - Recruiting

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