NCT01242371

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: Sheppard Pratt Health System · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Schizophrenia
• Schizoaffective Disorder

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Probiotic Supplement	Probiotic Supplement 1 tablet by mouth daily
DIETARY_SUPPLEMENT	Identical-appearing Placebo	Probiotic identical placebo 1 tablet by mouth daily

Timeline

• Start date: 2010-08-01
• Primary completion: 2012-08-01
• Completion: 2012-08-01
• First posted: 2010-11-17
• Last updated: 2019-02-05
• Results posted: 2013-11-14

Locations

1 site across 1 country: United States