Synbiotic Compound to Reduce Symptoms of Schizophrenia
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorSheppard Pratt Health System
About this trial
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
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Synbiotic Supplement
- Inert Compound
Treatment groups
68 Participants
are divided into 2 treatment groupsLocations
1Map coordinates are unavailable for these locations. Locations are shown below instead.
Sheppard Pratt Health SystemRecruiting21285, Batlimore, Maryland
United States
United StatesSponsors and collaborators
Source ClinicalTrials.gov