Synbiotic Compound to Reduce Symptoms of Schizophrenia

Last updated: April 19, 2023
Sponsor: Sheppard Pratt Health System
Overall Status: Active - Recruiting

Phase

2

Condition

Schizophrenia And Schizoaffective Disorders (Pediatric)

Tourette's Syndrome

Mood Disorders

Treatment

N/A

Clinical Study ID

NCT04226898
SMRI/SPHS: 2020-01
  • Ages 18-65
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Age 18-65, inclusive.
  • Capacity for written informed consent.
  • Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) diagnosisof schizophrenia or schizoaffective disorder (APA 2013) as determined by theStructured 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 Positiveand Negative Syndrome Scale (Kay et al., 1987) (PANSS) total score of 60 or higher ANDone or more of the following: one or more PANSS positive symptom scores of 4 orhigher; OR containing at least three positive or negative items with scores of 3 orhigher at the screening visit.
  • Receiving antipsychotic medication for at least 8 weeks prior to starting the studywith no medication changes within the previous 21 days.
  • Proficient in the English language.

Exclusion

Exclusion Criteria:

  • DSM-5 diagnosis of intellectual disability or comparable diagnosis determined byprevious versions of the DSM.
  • Any clinically significant or unstable medical disorder as determined by theinvestigators, including congestive heart failure, liver disease, renal failure, anydiagnosis of cancer undergoing active treatment.
  • A primary immunodeficiency condition such as HIV infection, or undergoing cancerchemotherapy, or receiving systemic corticosteroids, methotrexate or monoclonalantibodies 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 ortobacco, within the last three months prior to the screening visit. If the patient hasa positive drug toxicity screen at the time of visit 1 (screening) further evaluationby 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 anaerobicorganisms residing in the gastrointestinal tract may be minimally affected byantibiotics). Of note, patients on antibiotic may be re-screened once the minimumduration of time since antibiotics use has been met.
  • Current and regular use of a probiotic and or prebiotic supplement within the past 2weeks. Of note, patients taking prebiotic or probiotic supplements may be re-screened.
  • Documented inflammatory bowel disease (e.g. Crohn's disease or ulcerative colitis) orceliac disease

Study Design

Total Participants: 68
Study Start date:
February 21, 2022
Estimated Completion Date:
January 31, 2025

Study Description

A total of n=68 participants with schizophrenia or schizoaffective disorder who have residual psychotic symptoms which are of at least moderate severity will be randomized. Intestinal inflammation will be assessed through the measurement of antibodies to Saccharomyces cerevisiae, gliadin, Candida albicans as well as high-sensitivity C-Reactive protein and Pentraxin-3. The duration of the trial is 14 weeks: after a 2-week placebo run in, the participants will be randomized to receive the synbiotic compound or identical-appearing placebo over the 12 weeks of the randomized phase. The synbiotic compound is a quality-tested product, Probio-Tec ABCG-Stick-25, manufactured by ChrHansen which contains 4 strains of probiotic microorganisms - Bifidobacteria BB-12, Lactobacillus casei, Lactobacillus acidophilus, and Lactobacillus rhamnosus - and the prebiotic, inulin, a fructan-containing polysaccharide which has been shown to increase the level of non-pathogenic bacteria in the gastrointestinal tract. All participants will also be maintained on a stable regimen of psychiatric medications prescribed by their treating psychiatrist.

Connect with a study center

  • Sheppard Pratt Health System

    Baltimore, Maryland 21285
    United States

    Active - Recruiting

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