Tests a synbiotic supplement alongside usual medicines in schizophrenia
Tests a synbiotic supplement against a placebo in adults with schizophrenia.
Plain-language title generated from the registry record
Registry title: Synbiotic Compound to Reduce Symptoms of Schizophrenia
Key facts
- Where
- Batlimore, United StatesSee the site
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT04226898, who can take part
Where in United States
- Sheppard Pratt Health SystemBatlimore, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Sheppard Pratt Health System
- Trial code
- NCT04226898
- Record updated
- 7 April 2026
- Original 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.Read full original descriptionShow less
A Double-Blind Placebo-Controlled Trial of the Synbiotic Compound Probio-Tec ABCG for Schizophrenia Patients With and Without Elevated Markers of Gastrointestinal Inflammation
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.
Inclusion: 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: DSM-5 diagnosis of intellectual disability or comparable diagnosis determined by previous versions of the DSM; 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; 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; 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; 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; History of IV drug use; Documented inflammatory bowel disease (e.g. Crohn's disease or ulcerative colitis) or celiac disease; Pregnant or planning to become pregnant during the study period; 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.