Could a daily probiotic help tame schizophrenia?
NCT ID NCT04226898
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study is testing whether a daily synbiotic supplement (a mix of probiotics and prebiotics) can reduce symptoms of schizophrenia when taken alongside standard antipsychotic medications. Researchers are enrolling 68 adults with schizophrenia or schizoaffective disorder who have ongoing symptoms. Half will get the supplement, half a placebo, and changes in symptoms and thinking will be measured over several weeks.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- synbiotic supplement (Probio-Tec ABCG)
- What this could lead to
- If it works, this could point toward a simple, safe add-on treatment to help control schizophrenia symptoms.
- What could go wrong
- This is a small, early-phase trial (68 people) testing a supplement, not a new drug. The effect may be small or no better than placebo.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 68 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2022
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Sheppard Pratt Health System
RECRUITINGBatlimore, Maryland, 21285, United States
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