Double-Blind Trial of a Probiotic Supplement to Reduce the Symptoms of Schizophrenia
|Schizophrenia Schizoaffective Disorder||Dietary Supplement: Probiotic Supplement Dietary Supplement: Identical-appearing Placebo|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Double-Blind Placebo-Controlled Trial of a Probiotic Supplement to Reduce the Symptoms of Schizophrenia|
- 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) [ Time Frame: 14 weeks (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.
- Gastrointestinal Functioning From the Beginning to the End of the Double-blind Treatment Phase Weeks 0-14 [ Time Frame: 14 weeks (weeks 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 & 14) ]Self report rating of difficulty moving bowels on a 4 point scale from "no difficulty" to "severe difficulty"
- Measurement of Gliadin and Casein Antibody Levels [ Time Frame: 16 weeks (baseline prior to placebo run in to week 14) ]
|Study Start Date:||August 2010|
|Study Completion Date:||August 2012|
|Primary Completion Date:||August 2012 (Final data collection date for primary outcome measure)|
Active Comparator: Probiotic Supplement
Probiotic supplement 1 tablet by mouth daily for 14 weeks after 2 week placebo run-in
Dietary Supplement: Probiotic Supplement
Probiotic Supplement 1 tablet by mouth daily
Placebo Comparator: Identical-appearing Placebo
Identical appearing placebo 1 tablet by mouth daily for 14 weeks after 2 week placebo run-in
Dietary Supplement: Identical-appearing Placebo
Probiotic identical placebo 1 tablet by mouth daily
The primary aim of the current study is:
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:
- To assess the effect of probiotic treatment on patients' gastrointestinal functioning
- To study the effect of probiotic treatment in lowering the levels of antibodies to casein and gliadin.
- To investigate the association between the efficacy of probiotic therapy and initial levels of antibodies to gliadin and casein.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01242371
|United States, Maryland|
|Sheppart Pratt Health System|
|Towson, Maryland, United States, 21204|
|Principal Investigator:||Faith B Dickerson, PhD, MPH||Sheppard Pratt Health System|