Actively Recruiting

Phase Not Applicable
Age: 18Years - 60Years
All Genders
NCT05527210

Prebiotic Treatment in People With Schizophrenia

Led by University of Maryland, Baltimore · Updated on 2026-03-09

60

Participants Needed

1

Research Sites

205 weeks

Total Duration

On this page

Sponsors

U

University of Maryland, Baltimore

Lead Sponsor

N

National Center for Complementary and Integrative Health (NCCIH)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Prebiotic Treatment in People With Schizophrenia

Who Can Participate

Age: 18Years - 60Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • DSM-5 diagnosis of schizophrenia or schizoaffective disorder
  • Age 18 to 60 years
  • Considered clinically stable by the treating psychiatrist
  • Currently treated with an antipsychotic with no dose changes in last 14 days
  • Ability to participate in informed consent process with a score of 10 or greater on the Evaluation to Sign Consent
  • Body mass index (BMI) less than or equal to 40
Not Eligible

You will not qualify if you...

  • Gastrointestinal disorders that could affect schizophrenia treatment or increase risk, including Crohn's disease, irritable bowel syndrome, celiac disease
  • Organic brain disorders such as stroke, epilepsy, traumatic brain injury, or loss of consciousness over 30 minutes
  • Intellectual disability
  • Recent acute antibiotic use
  • 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 due to pregnancy
  • Alcohol or substance misuse (except caffeine and nicotine) within the last 3 months; mild marijuana misuse allowed

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Maryland Psyciatric Research Center

Catonsville, Maryland, United States, 21228

Actively Recruiting

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Research Team

M

Matt Glassman

CONTACT

J

Jennifer Zaranski, MA

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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