NCT05527210 · University of Maryland, Baltimore
Prebiotic Treatment in People With Schizophrenia
(FOCIS)
What this study 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.
View original scientific 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- DSM-5 diagnosis of schizophrenia or schizoaffective disorder;
- Age 18-60 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 the informed consent process, as determined by a score of 10 or greater on the Evaluation to Sign Consent;
Exclusion criteria
- 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
- 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 lactation secondary to pregnancy
- 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.
Where
- Catonsville, Maryland
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 9, 2026 · Source of record for eligibility and locations