Clinical trial NCT01242371: 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
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Schizoaffective Disorder
Keywords: Schizophrenia
Schizoaffective
Probiotic supplements
Gliadin
Casein
Lead sponsor: Sheppard Pratt Health System
Sponsor class: OTHER
Collaborators: name: Stanley Medical Research Institute
First posted: 2010-11-17
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

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.

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.

Primary outcomes:
measure: 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)
timeFrame: 14 weeks (week 0 to week 14)
Secondary outcomes:
measure: Gastrointestinal Functioning From the Beginning to the End of the Double-blind Treatment Phase Weeks 0-14
timeFrame: 14 weeks (weeks 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 & 14)
measure: Measurement of Gliadin and Casein Antibody Levels
timeFrame: 16 weeks (baseline prior to placebo run in to week 14)
Other outcomes:
Locations:
city: Towson
country: United States
facility: Sheppart Pratt Health System
state: Maryland
Study officials:
affiliation: Sheppard Pratt Health System
name: Faith B Dickerson, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
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.