Double-Blind Trial of a Probiotic Supplement to Reduce the Symptoms of Schizophrenia
|ClinicalTrials.gov Identifier: NCT01242371|
Recruitment Status : Completed
First Posted : November 17, 2010
Results First Posted : November 14, 2013
Last Update Posted : February 6, 2014
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia Schizoaffective Disorder||Dietary Supplement: Probiotic Supplement Dietary Supplement: Identical-appearing Placebo||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||65 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||A Double-Blind Placebo-Controlled Trial of a Probiotic Supplement to Reduce the Symptoms of Schizophrenia|
|Study Start Date :||August 2010|
|Actual Primary Completion Date :||August 2012|
|Actual Study Completion Date :||August 2012|
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
- 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) ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01242371
|United States, Maryland|
|Sheppart Pratt Health System|
|Towson, Maryland, United States, 21204|
|Principal Investigator:||Faith B Dickerson, PhD, MPH||Sheppard Pratt Health System|