RecruitingPhase 2NCT04226898

Synbiotic Compound to Reduce Symptoms of Schizophrenia

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


Sponsor

Sheppard Pratt Health System

Enrollment

68 participants

Start Date

Feb 21, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria7

  • 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 Criteria10

  • 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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Interventions

BIOLOGICALSynbiotic Supplement

Synbiotic supplement 1 powder stick by mouth daily

BIOLOGICALInert Compound

Synbiotic supplement identical placebo 1 powder stick by mouth daily


Locations(1)

Sheppard Pratt Health System

Batlimore, Maryland, United States

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NCT04226898


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