Actively Recruiting

Phase 2
Age: 18Years - 65Years
All Genders
NCT04226898

Synbiotic Compound to Reduce Symptoms of Schizophrenia

Led by Sheppard Pratt Health System · Updated on 2026-04-07

68

Participants Needed

1

Research Sites

301 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Synbiotic Compound to Reduce Symptoms of Schizophrenia

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 to 65 years
  • Able to provide written informed consent
  • Diagnosed with schizophrenia or schizoaffective disorder based on DSM-5 and SCID-5
  • Outpatient status at enrollment
  • Residual psychotic symptoms with PANSS total score of 60 or higher and specific positive symptom criteria
  • On stable antipsychotic medication for at least 8 weeks with no changes in last 21 days
  • Proficient in English
Not Eligible

You will not qualify if you...

  • Diagnosis of intellectual disability or similar
  • Any clinically significant or unstable medical disorder such as congestive heart failure, liver disease, renal failure, or active cancer treatment
  • Primary immunodeficiency or treatments affecting immune system
  • History of intravenous drug use
  • Moderate or severe substance use disorder (except caffeine or tobacco) within last 3 months
  • Participation in any investigational drug trial within last 30 days
  • Pregnant or planning pregnancy during study
  • Antibiotic use within 14 days prior to randomization
  • Current regular use of probiotic or prebiotic supplements within past 2 weeks
  • Diagnosed inflammatory bowel disease or celiac disease

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Sheppard Pratt Health System

Batlimore, Maryland, United States, 21285

Actively Recruiting

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Research Team

E

Emily Katsafanas

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Synbiotic Compound to Reduce Symptoms of Schizophrenia | DecenTrialz