Double-Blind Trial of a Probiotic Supplement to Reduce the Symptoms of Schizophrenia

A Double-Blind Placebo-Controlled Trial of a Probiotic Supplement to Reduce the Symptoms of Schizophrenia

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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia; Schizoaffective Disorder
• Intervention / Treatment: Dietary supplement: Probiotic Supplement; Dietary supplement: Identical-appearing Placebo

Detailed Description

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
• Enrollment (Actual): 65
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Towson, Maryland, United States, 21204
      • Sheppart Pratt Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	14 weeks (week 0 to week 14)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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"	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		16 weeks (baseline prior to placebo run in to week 14)

Collaborators and Investigators

• Sponsor: Sheppard Pratt Health System
• Collaborators: Stanley Medical Research Institute
• Investigators: Principal Investigator: Faith B Dickerson, PhD, MPH, Sheppard Pratt Health System

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Actual): August 1, 2012
• Study Completion (Actual): August 1, 2012

Study Registration Dates

• First Submitted: November 16, 2010
• First Submitted That Met QC Criteria: November 16, 2010
• First Posted (Estimate): November 17, 2010

Study Record Updates

• Last Update Posted (Actual): February 5, 2019
• Last Update Submitted That Met QC Criteria: January 17, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Schizophrenia; Schizoaffective; Probiotic supplements; Gliadin; Casein
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Psychotic Disorders
• Other Study ID Numbers: SMRI/SPHS 2010-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No