NCT04226898 · Sheppard Pratt Health System
Synbiotic Compound to Reduce Symptoms of Schizophrenia
What this study is about
The purpose of this study is to determine if taking a synbiotic supplement versus a placebo will reduce symptoms of schizophrenia when used in addition to standard antipsychotic medications.
View original scientific description
The purpose of this study is to determine if taking a synbiotic supplement versus a placebo will reduce symptoms of schizophrenia when used in addition to standard antipsychotic medications.
Interventions
BIOLOGICAL
Synbiotic Supplement
Synbiotic supplement 1 powder stick by mouth daily
BIOLOGICAL
Inert Compound
Synbiotic supplement identical placebo 1 powder stick by mouth daily
Primary outcome measures
Change in Positive and Negative Syndrome Scale (PANSS) Score From the Start to the End of the Double-blind Treatment Phase
Time frame: 12 weeks (week 2 to week 14)
The Positive and Negative Syndrome Scale (PANSS) measures psychiatric symptomatology, especially related to psychosis. The complete PANSS contains ratings for 30 symptoms, including 7 positive symptoms, 7 negative symptoms, and 16 general psychiatric symptoms. The severity of each symptom is rated on a scale ranging from 1 (minimal) to 7 (extreme); higher scores indicate increased symptomatology. Total PANSS scores include scores from all categories and range from 30 to 210 units on a scale.
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
- Age 18-65, inclusive.
- Capacity for written informed consent.
- Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) diagnosis of schizophrenia or schizoaffective disorder (APA 2013) as determined by the Structured Clinical Interview for DSM-5 Disorders (SCID-5).
- Outpatient at the time of enrollment.
- Residual psychotic symptoms of at least moderate severity as evidenced by a Positive and Negative Syndrome Scale (Kay et al., 1987) (PANSS) total score of 60 or higher AND one or more of the following: one or more PANSS positive symptom scores of 4 or higher; OR containing at least three positive or negative items with scores of 3 or higher at the screening visit.
- Receiving antipsychotic medication for at least 8 weeks prior to starting the study with no medication changes within the previous 21 days.
- Proficient in the English language.
Exclusion criteria
- DSM-5 diagnosis of intellectual disability or comparable diagnosis determined by previous versions of the DSM.
- Any clinically significant or unstable medical disorder as determined by the investigators, including congestive heart failure, liver disease, renal failure, any diagnosis of cancer undergoing active treatment.
- A primary immunodeficiency condition such as HIV infection, or undergoing cancer chemotherapy, or receiving systemic corticosteroids, methotrexate or monoclonal antibodies for treatment of an autoimmune disorder.
- History of IV drug use.
- DSM-5 diagnosis of a moderate or severe substance use disorder, except for caffeine or tobacco, within the last three months prior to the screening visit. If the patient has a positive drug toxicity screen at the time of visit 1 (screening) further evaluation by the investigator will be done of the substance use to determine eligibility.
- Participated in any investigational drug trial in the past 30 days.
- Pregnant or planning to become pregnant during the study period.
- Receipt of antibiotic medication within the 14 days prior to visit 2 (as anaerobic organisms residing in the gastrointestinal tract may be minimally affected by antibiotics). Of note, patients on antibiotic may be re-screened once the minimum duration of time since antibiotics use has been met.
- Current and regular use of a probiotic and or prebiotic supplement within the past 2 weeks. Of note, patients taking prebiotic or probiotic supplements may be re-screened.
- Documented inflammatory bowel disease (e.g. Crohn's disease or ulcerative colitis) or celiac disease
Where
- Batlimore, Maryland
Related conditions & keywords
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 Apr 7, 2026 · Source of record for eligibility and locations