Back to resultsDouble-Blind Trial of a Probiotic Supplement to Reduce the Symptoms of Schizophrenia
Primary Purpose
Schizophrenia, Schizoaffective Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Probiotic Supplement
Identical-appearing Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Schizoaffective, Probiotic supplements, Gliadin, Casein
Eligibility Criteria
Inclusion Criteria:
- Age 18-65.
- Capacity for written informed consent.
- Primary Axis I diagnosis (DSM-IV) of schizophrenia, any type, OR schizoaffective disorder (APA, 1994).
- Currently an outpatient at the time of enrollment.
- Residual psychotic symptoms which are at least moderately severe as evidenced by one or more PANSS positive symptom scores, and/or PANSS negative symptom scores of 4 or more; OR a total PANSS score of 50 or more, containing at least three positive or negative items with scores of 3 or more at screening.
- Conformance to PORT Treatment Recommendation re Maintenance Antipsychotic Medication Dose (Buchanan et al., 2010).
- Receiving antipsychotic medication for at least 8 weeks prior to starting the study with no medication changes within the previous 21 days.
- Proficient in the English language.
Exclusion Criteria:
- Diagnosis of mental retardation.
- Any clinically significant or unstable medical disorder as determined by the investigators, including congestive heart failure, abnormal liver function or disease, renal failure, acute pancreatitis, any diagnosis of cancer undergoing active treatment, HIV infection or other immunodeficiency condition.
- History of IV drug use.
- Primary diagnosis of substance abuse or dependence according to DSM-IV criteria within the last three months.
- Participated in any investigational drug trial in the past 30 days.
- Pregnant or planning to become pregnant during the study period.
- Receipt of antibiotic medication within the previous 14 days (as anaerobic organisms residing in the gastrointestinal tract may be minimally affected by antibiotics).
- Documented celiac disease (as such persons should be on a gluten-free diet as this is the standard care).
- Of note, the investigators are not limiting the study to individuals with elevated levels of gliadin or casein antibodies as the investigators intend to look at these levels as a predictor of response.
Sites / Locations
- Sheppart Pratt Health System
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Probiotic Supplement
Identical-appearing Placebo
Arm Description
Probiotic supplement 1 tablet by mouth daily for 14 weeks after 2 week placebo run-in
Identical appearing placebo 1 tablet by mouth daily for 14 weeks after 2 week placebo run-in
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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"
Measurement of Gliadin and Casein Antibody Levels
Full Information
NCT ID
NCT01242371
First Posted
November 16, 2010
Last Updated
January 17, 2019
Sponsor
Sheppard Pratt Health System
Collaborators
Stanley Medical Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT01242371
Brief Title
Double-Blind Trial of a Probiotic Supplement to Reduce the Symptoms of Schizophrenia
Official Title
A Double-Blind Placebo-Controlled Trial of a Probiotic Supplement to Reduce the Symptoms of Schizophrenia
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sheppard Pratt Health System
Collaborators
Stanley Medical Research Institute
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizoaffective Disorder
Keywords
Schizophrenia, Schizoaffective, Probiotic supplements, Gliadin, Casein
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
65 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Probiotic Supplement
Arm Type
Active Comparator
Arm Description
Probiotic supplement 1 tablet by mouth daily for 14 weeks after 2 week placebo run-in
Arm Title
Identical-appearing Placebo
Arm Type
Placebo Comparator
Arm Description
Identical appearing placebo 1 tablet by mouth daily for 14 weeks after 2 week placebo run-in
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotic Supplement
Intervention Description
Probiotic Supplement 1 tablet by mouth daily
Intervention Type
Dietary Supplement
Intervention Name(s)
Identical-appearing Placebo
Intervention Description
Probiotic identical placebo 1 tablet by mouth daily
Primary Outcome Measure Information:
Title
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)
Description
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)
Secondary Outcome Measure Information:
Title
Gastrointestinal Functioning From the Beginning to the End of the Double-blind Treatment Phase Weeks 0-14
Description
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)
Title
Measurement of Gliadin and Casein Antibody Levels
Time Frame
16 weeks (baseline prior to placebo run in to week 14)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 18-65.
Capacity for written informed consent.
Primary Axis I diagnosis (DSM-IV) of schizophrenia, any type, OR schizoaffective disorder (APA, 1994).
Currently an outpatient at the time of enrollment.
Residual psychotic symptoms which are at least moderately severe as evidenced by one or more PANSS positive symptom scores, and/or PANSS negative symptom scores of 4 or more; OR a total PANSS score of 50 or more, containing at least three positive or negative items with scores of 3 or more at screening.
Conformance to PORT Treatment Recommendation re Maintenance Antipsychotic Medication Dose (Buchanan et al., 2010).
Receiving antipsychotic medication for at least 8 weeks prior to starting the study with no medication changes within the previous 21 days.
Proficient in the English language.
Exclusion Criteria:
Diagnosis of mental retardation.
Any clinically significant or unstable medical disorder as determined by the investigators, including congestive heart failure, abnormal liver function or disease, renal failure, acute pancreatitis, any diagnosis of cancer undergoing active treatment, HIV infection or other immunodeficiency condition.
History of IV drug use.
Primary diagnosis of substance abuse or dependence according to DSM-IV criteria within the last three months.
Participated in any investigational drug trial in the past 30 days.
Pregnant or planning to become pregnant during the study period.
Receipt of antibiotic medication within the previous 14 days (as anaerobic organisms residing in the gastrointestinal tract may be minimally affected by antibiotics).
Documented celiac disease (as such persons should be on a gluten-free diet as this is the standard care).
Of note, the investigators are not limiting the study to individuals with elevated levels of gliadin or casein antibodies as the investigators intend to look at these levels as a predictor of response.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Faith B Dickerson, PhD, MPH
Organizational Affiliation
Sheppard Pratt Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sheppart Pratt Health System
City
Towson
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
24940526
Citation
Dickerson FB, Stallings C, Origoni A, Katsafanas E, Savage CL, Schweinfurth LA, Goga J, Khushalani S, Yolken RH. Effect of probiotic supplementation on schizophrenia symptoms and association with gastrointestinal functioning: a randomized, placebo-controlled trial. Prim Care Companion CNS Disord. 2014;16(1):PCC.13m01579. doi: 10.4088/PCC.13m01579. Epub 2014 Feb 13.
Results Reference
derived
Learn more about this trial
Double-Blind Trial of a Probiotic Supplement to Reduce the Symptoms of Schizophrenia
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