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Synbiotic Supplement for Schizophrenia and Schizoaffective Disorder

This study is looking into whether a synbiotic supplement, Probio-Tec ABCG-Stick-25, can help reduce symptoms of schizophrenia or schizoaffective disorder when taken alongside your usual antipsychotic medications. You would take one powder stick by mouth daily. The study is comparing this supplement to an identical-looking inactive compound (placebo). Researchers will measure changes in your symptoms using a tool called the Positive and Negative Syndrome Scale (PANSS) over 12 weeks. To join, you need to be between 18 and 65 years old, have a diagnosis of schizophrenia or schizoaffective disorder, and be an outpatient. The study aims to enroll 68 participants.

Study design
This is an interventional study where 68 participants will be randomly assigned to receive either the synbiotic supplement or a placebo. It is a double-blind study, meaning neither you nor your doctor will know which treatment you are receiving.
What's involved
You would participate in the study for 14 weeks. This includes a 2-week period where everyone receives a placebo, followed by 12 weeks where you would take either the synbiotic supplement or the placebo daily. You will also have assessments for intestinal inflammation.
Compensation
Not stated in the trial record.
Follow-up
Your symptoms will be measured at the end of the 12-week double-blind treatment phase.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04226898

Synbiotic Compound to Reduce Symptoms of Schizophrenia

Recruiting
PHASE2Ages 18–65InterventionalTreatment
Sheppard Pratt Health System
~68 participants
Updated 2026-04-07 on ClinicalTrials.gov
What's tested:Synbiotic SupplementInert Compound

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Positive and Negative Syndrome Scale (PANSS) Score From the Start to the End of the Double-blind Treatment Phase
Measured over 12 weeks (week 2 to week 14)

Conditions

Schizophrenia
Schizoaffective Disorder

Explore related trials

Schizoaffective DisorderSchizophrenia

Where it's being run

1 sites across 1 states
Maryland1

Study leadership

  • Faith Dickerson, PhD, MPH · PRINCIPAL_INVESTIGATOR · Sheppard Pratt Health System

Who to contact

Emily Katsafanas
[email protected]
410-938-4360
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

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.
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

What this trial measures

  • Change in Positive and Negative Syndrome Scale (PANSS) Score From the Start to the End of the Double-blind Treatment Phase12 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.