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Synbiotic Therapy for Schizophrenia

Phase 2

Recruiting

Led By Faith Dickerson, PhD, MPH

Research Sponsored by Sheppard Pratt Health System

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Residual psychotic symptoms of at least moderate severity as evidenced by a Positive and Negative Syndrome Scale (PANSS) total score of 60 or higher AND one or more of the following: one or more PANSS positive symptom scores of 4 or higher; OR containing at least three positive or negative items with scores of 3 or higher at the screening visit

Outpatient at the time of enrollment

Must not have

A primary immunodeficiency condition such as HIV infection, or undergoing cancer chemotherapy, or receiving systemic corticosteroids, methotrexate or monoclonal antibodies for treatment of an autoimmune disorder

Documented inflammatory bowel disease (e.g. Crohn's disease or ulcerative colitis) or celiac disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 14 weeks (week 0 to week 14)

Summary

This trial will compare the effects of a synbiotic supplement versus a placebo on symptoms of schizophrenia when used in addition to standard antipsychotic medications.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects of the synbiotic supplement may include digestive discomfort such as bloating or gas due to changes in gut bacteria but specific side effect profiles will be monitored throughout the study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have moderate to severe psychotic symptoms.

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I am not hospitalized and can visit the clinic for treatments.

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I am between 18 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have been diagnosed with Crohn's, ulcerative colitis, or celiac disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 14 weeks (week 0 to week 14)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~14 weeks (week 0 to week 14)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 14 weeks (week 0 to week 14) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Positive and Negative Syndrome Scale (PANSS) Score From the Start to the End of the Double-blind Treatment Phase

Secondary study objectives

Placebos

Intestinal Inflammation Markers (#1) Antibodies to Saccharomyces cerevisiae

Intestinal Inflammation Markers (#2) Antibodies to Gliadin

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Synbiotic SupplementExperimental Treatment1 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 CompoundPlacebo Group1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Synbiotic Supplement

2016

N/A

~100

0 / 5Eligibility criteria met