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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a synbiotic supplement can reduce symptoms of schizophrenia when combined with regular antipsychotic medications. Participants will take either the synbiotic supplement, which includes probiotics and inulin (a type of fiber), or a placebo for 12 weeks. It targets individuals with schizophrenia or schizoaffective disorder who experience moderate psychotic symptoms and have been on stable antipsychotic medication for at least eight weeks. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

You can continue taking your current antipsychotic medications, as the study is designed to test a supplement alongside them. However, if you are taking antibiotics or probiotic/prebiotic supplements, you may need to stop and wait for a certain period before joining the trial.

Is there any evidence suggesting that the synbiotic supplement is likely to be safe for humans?

Research has shown that probiotics and similar supplements are usually safe for people with schizophrenia. One study found that probiotics can help these individuals without causing major side effects. Another study examined 11 cases of people with schizophrenia and found no serious problems from probiotics. These findings suggest that taking a synbiotic supplement, which combines probiotics with prebiotics (foods that help probiotics work), is likely safe for most people. However, individuals should consider personal reactions and consult a healthcare provider before starting any new treatment. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for schizophrenia?

Unlike the standard treatments for schizophrenia, which often include antipsychotic medications, the synbiotic supplement being studied introduces a new approach by targeting gut health. This treatment is unique because it combines four strains of probiotic bacteria and inulin, a prebiotic fiber, to potentially influence brain function through the gut-brain axis. Researchers are excited about this treatment because it offers a novel mechanism of action by enhancing the gut microbiome, which might improve symptoms in a way that current medications don't.

What evidence suggests that this synbiotic supplement might be an effective treatment for schizophrenia?

This trial will compare a synbiotic supplement with a placebo to evaluate its effects on schizophrenia symptoms. Research suggests that synbiotic supplements, a mix of probiotics and prebiotics, might help reduce these symptoms. One study found that probiotics decreased symptoms in people with schizophrenia and seemed to reduce common stomach problems. In another study, probiotics combined with added vitamin D improved symptoms over 12 weeks. However, some reviews found no significant changes in symptoms with probiotics. Overall, early research shows possible benefits, but the results remain mixed. ^{6 7 8 9 10}

Who Is on the Research Team?

Faith Dickerson, PhD, MPH

Principal Investigator

Sheppard Pratt Health System

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0022395625000585

Impact of probiotic treatment on clinical symptom reduction ... The synthesis of available data suggests that probiotic supplementation may effectively reduce clinical symptoms in schizophrenia.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39551901/

The efficacy of Lactobacillus and Bifidobacterium in ... The probiotic intervention significantly reduced gastrointestinal discomfort among schizophrenia patients (P = 0.003). This study suggests that probiotics could ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11085935/

Effectiveness of Psychobiotics in the Treatment of Psychiatric ... The administration of probiotics plus vitamin D for schizophrenia for 12 weeks chronically had beneficial effects on the PANSS score. Jamilian H et al., 2021 [ ...

4. frontiersin.org frontiersin.org/journals/behavioral-neuroscience/articles/10.3389/fnbeh.2023.1111349/full

Systematic review of probiotics as an adjuvant treatment for ... The schizophrenia studies (n = 2) found adjuvant probiotic treatment to have no significant difference in clinical outcomes, but it was found to ...

5. nature.com nature.com/articles/s41398-024-02735-z

Are probiotics effective in reducing the metabolic side ... Individuals with severe mental illness (SMI), such as chronic depression and schizophrenia, have an increased risk of obesity and metabolic ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4048142/

Effect of Probiotic Supplementation on Schizophrenia ... This is the first study to investigate the effect of probiotic supplementation on schizophrenia symptoms and the association with gastrointestinal functioning.

7. sciencedirect.com sciencedirect.com/science/article/pii/S0149763424000290

Probiotic, prebiotic, synbiotic and fermented food ... Studies frequently focused on schizophrenia (n = 11) and bipolar disorder (n = 5) and there were limited studies in anorexia nervosa (n = 4), ADHD ( ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12111037/

Effect of Supplementation with Probiotics in Patients with ... Supplementation with probiotics seems to confer protective effects in individuals with schizophrenia (SZ), although available results are ...

9. mdpi.com mdpi.com/2072-6643/13/4/1152

The Gut Microbiome in Schizophrenia and the Potential ... In this article, we review the existing evidence surrounding the gut microbiome in schizophrenia and the potential for antipsychotics to cause adverse metabolic ...

10. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1002/npr2.12431

Co‐administration of probiotic and vitamin D significantly ... In a systematic review by Ng et al. (2019), three clinical studies that investigated the effect of probiotic supplementation on schizophrenia ...