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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Synbiotic Supplement
Biological/VaccineSynbiotic supplement 1 powder stick by mouth daily
Inert Compound
Biological/VaccineSynbiotic supplement identical placebo 1 powder stick by mouth daily
Treatment groups
68 Participants
are divided into 2 treatment groupsGroup A: Synbiotic SupplementExperimental treatment 1 intervention
Group B: Inert CompoundPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Positive and Negative Syndrome Scale (PANSS) Score From the Start to the End of the Double-blind Treatment Phase
The Positive and Negative Syndrome Scale (PANSS) measures psychiatric symptomatology, especially related to psychosis. The complete PANSS contains ratings for 30 symptoms, including 7 positive symptoms, 7 negative symptoms, and 16 general psychiatric symptoms. The severity of each symptom is rated on a scale ranging from 1 (minimal) to 7 (extreme); higher scores indicate increased symptomatology. Total PANSS scores include scores from all categories and range from 30 to 210 units on a scale.
Time frame
12 weeks (week 2 to week 14)Secondary outcomes
1
Change in the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) score from the start of the placebo run-in to the end of the double-blind phase
Cognitive performance is measured by the MATRICS Consensus Cognitive Battery composite score in participants. MCCB is comprised of 10 tests: Trail Making Test Part A; Brief Assessment in Cognition in Schizophrenia Symbol Coding; Hopkins Verbal Learning Test-Revised; Wechsler Memory Scale-III Spatial Span; Letter Number Sequencing; Neuropsychological Assessment Battery Mazes; Brief Visuospatial Memory Test-Revised; Category Fluency Animal Naming; Mayer-Salovey-Caruso Emotional Intelligence Test Managing Emotions; and Continuous Performance Test-Identical Pairs. For each test, a score is derived based on the raw item values. Each of the individual item raw scores is standardized to age and gender corrected tscores which are then summed to convert into a composite score ranging from \<214-\>486 based on the MCCB scoring manual, with a higher score reflecting better performance.
Time frame
14 weeks (week 0 to week 14)2
Intestinal Inflammation Markers (#1) Antibodies to Saccharomyces cerevisiae
Levels of intestinal inflammation will be assessed by the measurement of antibodies by immunoassays to Saccharomyces cerevisiae. (All of the immunoassays will be analyzed on the same scale. This is accomplished by standardizing the optical density values obtained from the immunoassays to those of a control population without a psychiatric disorder normalized to have a mean value of 1 and a standard deviation of 1. To adjust for multiple comparisons in the analysis of the 5 markers, the false discovery correction of Benjamani-Hochberg will be used.)
Time frame
Screening, Week 8, Week 143
Intestinal Inflammation Markers (#2) Antibodies to Gliadin
Levels of intestinal inflammation will be assessed by the measurement of antibodies by immunoassays to gliadin. (All of the immuoassays will be analyzed on the same scale. This is accomplished by standardizing the optical density values obtained from the immunoassays to those of a control population without a psychiatric disorder normalized to have a mean value of 1 and a standard deviation of 1. To adjust for multiple comparisons in the analysis of the 5 markers, the false discovery correction of Benjamani-Hochberg will be used.)
Time frame
Screening, Week 8, Week 144
Intestinal Inflammation Markers (#3) Antibodies to Candida albicans
Levels of intestinal inflammation will be assessed by the measurement of antibodies by immunoassays to Candida albicans. (All of the immunoassays will be analyzed on the same scale. This is accomplished by standardizing the optical density values obtained from the immunoassays to those of a control population without a psychiatric disorder normalized to have a mean value of 1 and a standard deviation of 1. To adjust for multiple comparisons in the analysis of the 5 markers, the false discovery correction of Benjamani-Hochberg will be used.)
Time frame
Screening, Week 8, Week 14Locations
1Map coordinates are unavailable for these locations. Locations are shown below instead.
Sheppard Pratt Health SystemRecruiting21285, Batlimore, Maryland
United States
United StatesSponsors and contacts
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Source ClinicalTrials.gov