Synbiotic Therapy for Schizophrenia

Overseen By Emily Katsafanas

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Sheppard Pratt Health System

Must be taking: Antipsychotics

Must not be taking: Antibiotics, Probiotics

Disqualifiers: Intellectual disability, Cancer, HIV, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

68 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to determine if taking a synbiotic supplement versus a placebo will reduce symptoms of schizophrenia when used in addition to standard antipsychotic medications.

Research Team

Faith Dickerson, PhD, MPH

Principal Investigator

Sheppard Pratt Health System

Eligibility Criteria

Adults aged 18-65 with schizophrenia or schizoaffective disorder, experiencing moderate symptoms despite antipsychotic medication, can join. They must understand English and give informed consent. Excluded are those with intellectual disabilities, recent substance abuse (except caffeine/tobacco), pregnancy plans, antibiotic use within two weeks, immune deficiencies, IV drug history, certain digestive diseases or unstable medical conditions.

Inclusion Criteria

Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) diagnosis of schizophrenia or schizoaffective disorder (APA 2013) as determined by the Structured Clinical Interview for DSM-5 Disorders (SCID-5)

I have been on the same antipsychotic medication for at least 8 weeks without changes.

I can understand and sign the consent form.

Exclusion Criteria

DSM-5 diagnosis of intellectual disability or comparable diagnosis determined by previous versions of the DSM

I have a weakened immune system due to HIV, cancer treatment, or medication for autoimmune disorders.

I do not have any serious or unstable health conditions.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Placebo Run-in

Participants receive a placebo to establish baseline measurements

2 weeks

Treatment

Participants are randomized to receive either the synbiotic compound or placebo

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Synbiotic Supplement

Trial Overview The trial is testing if a synbiotic supplement can reduce schizophrenia symptoms alongside standard medications compared to an inert placebo. Participants will be randomly assigned to receive either the synbiotic compound or placebo.

Participant Groups

Group I: Synbiotic Supplement Experimental Treatment 1 Intervention

The active synbiotic supplement consists of a stick/packet containing 4 strains of probiotic microorganisms: Lactobacillus acidophilus, LA-5® (material number 501082 FD LAK KGPharma); Lactobacillis paracasei subsp. paracasei, L. CASEI 431® (material number 684301 FD L. casei 431 HA Granulate); Lactobacillus rhamnosus, LGG® (material number 699817 FD LGG HA-W-IF); and Bifidobacterium animalis subsp. lactis, BB-12® (material number 699813 FD BB-12 HA-W-IF). In addition, the stick/sachet contains 5 g inulin. The product is a powder which participants will be asked to take with liquid or food. In this arm, the participant will take 1 powder stick of the synbiotic supplement once a day for 12 weeks after a 2-week placebo run-in.

Group II: Inert Compound Placebo Group 1 Intervention

The inert compound placebo looks identical to the synbiotic supplement. In this arm, the participant will take 1 powder stick of the placebo daily for 12 weeks after a 2 week placebo run-in.

Who Is Running the Clinical Trial?

Sheppard Pratt Health System

Lead Sponsor

Trials

23

Recruited

7,800+