Synbiotic supplement to reduce schizophrenia symptoms

A Double-Blind Placebo-Controlled Trial of the Synbiotic Compound Probio-Tec ABCG for Schizophrenia Patients With and Without Elevated Markers of Gastrointestinal Inflammation

It will test whether taking a synbiotic supplement with regular antipsychotic medication helps adults with schizophrenia or schizoaffective disorder who still have moderate psychotic symptoms.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 68 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Sheppard Pratt Health System (Academic / other)
• Drugs / interventions: chemotherapy, methotrexate
• Locations: 1 site (Batlimore, Maryland)
• Trial ID: NCT04226898 on ClinicalTrials.gov

What this trial studies

This randomized, placebo-controlled Phase 2 trial will enroll 68 outpatients and runs 14 weeks, including a 2-week placebo run-in followed by a 12-week randomized phase. Participants remain on stable antipsychotic medication and will be randomized to receive either the synbiotic product Probio-Tec ABCG-Stick-25 or an identical-appearing placebo. The synbiotic contains four probiotic strains (Bifidobacteria BB-12, Lactobacillus casei, Lactobacillus acidophilus, Lactobacillus rhamnosus) plus the prebiotic inulin. Intestinal inflammation markers (antibodies to Saccharomyces cerevisiae, gliadin, Candida albicans, high-sensitivity CRP, and Pentraxin-3) and clinical symptom measures are collected to compare outcomes between groups.

Who should consider this trial

Good fit: Adults aged 18–65 with a DSM-5 diagnosis of schizophrenia or schizoaffective disorder who are outpatients on a stable antipsychotic regimen and have at least moderate residual psychotic symptoms (PANSS ≥60) are the intended participants.

Not a fit: People outside the 18–65 age range, those with an intellectual disability, inpatients, those not on a stable antipsychotic regimen, or those unable to provide informed consent are unlikely to be eligible or benefit.

Why it matters

Potential benefit: If successful, this adjunct synbiotic could modestly reduce residual psychotic symptoms and related gut inflammation when added to standard antipsychotic treatment.

How similar studies have performed: Small clinical studies of probiotics and synbiotics in psychiatric disorders have shown mixed and generally modest benefits, so the approach is promising but not yet proven.

Eligibility criteria

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 this trial is running

Batlimore, Maryland

• Sheppard Pratt Health System — Batlimore, Maryland, United States (Recruiting)

Study contacts

• Principal investigator: Faith Dickerson, PhD, MPH — Sheppard Pratt Health System
• Study coordinator: Emily Katsafanas

Conditions Schizophrenia; Schizoaffective Disorder; Synbiotics; Synbiotic