RECRUITING

Prebiotic Treatment in People With Schizophrenia

Description

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.

Study Overview

Study Details

Study overview

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.

Prebiotic Treatment in People With Schizophrenia

Prebiotic Treatment in People With Schizophrenia

Condition
Schizophrenia
Intervention / Treatment

-

Contacts and Locations

Catonsville

Maryland Psyciatric Research Center, Catonsville, Maryland, United States, 21228

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 1. 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
  • 2. Organic brain disorder, including cerebrovascular accident; epilepsy; traumatic brain 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 (except caffeine and nicotine) within the last 3 months will be excluded. Participants who meet DSM 5 criteria for marijuana misuse - mild will be included in the study.

Ages Eligible for Study

18 Years to 60 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Maryland, Baltimore,

Robert Buchanan, M.D., PRINCIPAL_INVESTIGATOR, University of Maryland, Baltimore

Study Record Dates

2026-01-31