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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2012-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Synbiotic Compound to Reduce Symptoms of Schizophrenia

NCT04226898

Schizophrenia Schizoaffective Disorder

UNKNOWN PHASE2

Prebiotic Treatment in People With Schizophrenia

NCT05527210

Schizophrenia Schizoaffective Disorder

RECRUITING NA

Antipsychotic Effects of Probiotics and Prebiotics on Patients With Schizophrenia

NCT04291469

Schizophrenia

UNKNOWN NA

Sulforaphane to Reduce Symptoms of Schizophrenia

NCT02810964

Schizophrenia Schizoaffective Disorder

COMPLETED PHASE2

Effect of High-Dose B-Complex Vitamins on the Symptoms of Schizophrenia

NCT00403247

Schizophrenia Schizoaffective Disorder

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Schizophrenia Schizoaffective Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Probiotic Supplement

Probiotic supplement 1 tablet by mouth daily for 14 weeks after 2 week placebo run-in

Group Type ACTIVE_COMPARATOR

Probiotic Supplement

Intervention Type DIETARY_SUPPLEMENT

Probiotic Supplement 1 tablet by mouth daily

Identical-appearing Placebo

Identical appearing placebo 1 tablet by mouth daily for 14 weeks after 2 week placebo run-in

Group Type PLACEBO_COMPARATOR

Identical-appearing Placebo

Intervention Type DIETARY_SUPPLEMENT

Probiotic identical placebo 1 tablet by mouth daily

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Probiotic Supplement

Probiotic Supplement 1 tablet by mouth daily

Intervention Type DIETARY_SUPPLEMENT

Identical-appearing Placebo

Probiotic identical placebo 1 tablet by mouth daily

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No