The investigators intend to explore the hypothesis that symptoms of schizophrenia may be reduced by the administration of a probiotic supplement when used in addition to standard antipsychotic medications.
The primary aim of the current study is: 1. To evaluate the safety and efficacy of a supplemental probiotic therapy, containing the microorganisms Lactobacillus rhamnosus GG and Bifidobacterium lanimalis subsp. lactis (BB12), for individuals with schizophrenia who have residual psychotic symptoms of at least moderate severity. Secondary aims of the study are: 2. To assess the effect of probiotic treatment on patients' gastrointestinal functioning 3. To study the effect of probiotic treatment in lowering the levels of antibodies to casein and gliadin. 4. To investigate the association between the efficacy of probiotic therapy and initial levels of antibodies to gliadin and casein.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
65
Probiotic Supplement 1 tablet by mouth daily
Probiotic identical placebo 1 tablet by mouth daily
Sheppart Pratt Health System
Towson, Maryland, United States
Change in Positive and Negative Syndrome Scale (PANSS) Score From the Start to the End of the Double-blind Treatment Phase (Week 0 to Week 14)
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: 14 weeks (week 0 to week 14)
Gastrointestinal Functioning From the Beginning to the End of the Double-blind Treatment Phase Weeks 0-14
Self report rating of difficulty moving bowels on a 4 point scale from "no difficulty" to "severe difficulty"
Time frame: 14 weeks (weeks 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 & 14)
Measurement of Gliadin and Casein Antibody Levels
Time frame: 16 weeks (baseline prior to placebo run in to week 14)
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