Prebiotics for Schizophrenia

(FOCIS Trial)

Overseen By Sarah Caimona

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Maryland, Baltimore

Must be taking: Antipsychotics

Must not be taking: Antibiotics, Immune therapy

Disqualifiers: Gastrointestinal disorders, Brain disorder, others

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

60 Participants Needed

Trial Summary

What is the purpose of this trial?

The proposed project is based on the observation that schizophrenia is characterized by a chronic pro-inflammatory state, which contributes to the severity of a number of the clinical manifestations of the illness, including cognitive impairments, the treatment of which represents a critically important unmet therapeutic need.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must be on a stable dose of antipsychotic medication for at least 14 days before joining. If you are using antibiotics, immune therapy, or prebiotics/probiotics, you may need to stop those before participating.

What evidence supports the effectiveness of the prebiotic treatment for schizophrenia?

Research suggests that prebiotics may help manage symptoms of schizophrenia by improving gut health, which is linked to brain function. Prebiotics have shown potential in enhancing cognitive function and reducing weight gain, which are common issues in schizophrenia. ^{1 2 3 4 5}

Is the prebiotic treatment generally safe for humans?

Prebiotics, including those like oligofructose-enriched inulin, are generally considered safe for human consumption and have been studied for their effects on gut health and metabolism. They are often used to support gut microbiota, which can have positive effects on mental health and metabolic conditions. ^{1 2 4 6 7}

How is the prebiotic treatment for schizophrenia different from other treatments?

The prebiotic treatment for schizophrenia is unique because it targets the gut microbiome, which may help improve symptoms and reduce side effects like weight gain associated with traditional antipsychotic drugs. Unlike standard treatments, this approach uses dietary fibers to potentially enhance cognitive function and manage metabolic issues by influencing the gut-brain axis. ^{1 2 3 4 8}

Research Team

Robert Buchanan, M.D.

Principal Investigator

University of Maryland, Baltimore

Eligibility Criteria

Adults aged 18-60 with a stable condition of schizophrenia or schizoaffective disorder, not on recent immune therapy or prebiotic treatment, and without severe brain injury, gastrointestinal disorders, substance misuse (except mild marijuana use), intellectual disability, pregnancy, or acute antibiotic use.

Inclusion Criteria

I am on a stable dose of antipsychotic medication for the past 14 days.

Considered clinically stable by the treating psychiatrist

BMI ≤ 40

Exclusion Criteria

Pregnant or lactation secondary to pregnancy

I am currently taking antibiotics.

Intellectual disability

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a placebo or prebiotic treatment for 12 weeks to assess changes in serum butyrate levels, cognitive performance, and symptoms

12 weeks

Regular visits for monitoring and assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Placebo Prebiotic
• Prebiotic

Trial Overview The trial is testing the effects of a prebiotic supplement versus a placebo in people with schizophrenia. The goal is to see if the prebiotic can reduce inflammation and improve cognitive impairments associated with the illness.

Participant Groups

Group I: Active Study Med Active Control 1 Intervention

Participants randomized to active study medication will mix 4g of powder prebiotic with water, 3 times a day for 12 weeks.

Group II: Placebo Placebo Group 1 Intervention

Participants randomized to active study medication will mix 4g of powder placebo with water, 3 times a day for 12 weeks.

Who Is Running the Clinical Trial?

University of Maryland, Baltimore

Lead Sponsor

Trials

729

Recruited

540,000+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials

886

Recruited

677,000+

Findings from Research

Gut microbial dysbiosis may play a role in schizophrenia, suggesting that improving gut health through biotherapeutic products like probiotics, prebiotics, and polyphenols could be a promising non-pharmacological treatment option.

These biotherapeutic approaches may enhance cognitive function and other symptoms of schizophrenia by positively influencing the gut-brain axis and increasing brain-derived neurotrophic factors, highlighting the need for further clinical assessment of these treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modulation of Gut Microbial Diversity through Non-Pharmaceutical Approaches to Treat Schizophrenia. Munawar, N., Ahmad, A., Anwar, MA., et al.[2022]

Prebiotic dietary supplements may help improve cognitive deficits and manage weight gain in individuals with schizophrenia, based on promising preclinical studies showing benefits in learning, memory, and inflammation reduction.

While prebiotics have shown positive effects in animal studies, their efficacy in enhancing cognition and alleviating symptoms in humans with schizophrenia still needs to be thoroughly evaluated.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can prebiotics assist in the management of cognition and weight gain in schizophrenia? Kao, AC., Burnet, PWJ., Lennox, BR.[2019]

Pro- and prebiotics have been shown to positively influence the gut-brain axis, potentially reducing the incidence of mental disorders such as depression, anxiety, and Alzheimer's disease.

While there is evidence suggesting that these compounds can enhance central nervous system function and aid in the prevention and treatment of brain disorders, further human studies and clinical trials are necessary to confirm their efficacy and establish therapeutic guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of probiotics and prebiotics in modulating of the gut-brain axis. Ansari, F., Neshat, M., Pourjafar, H., et al.[2023]

Changes in gut microbiota (GMB) composition are linked to the development of schizophrenia (SCZ) and the metabolic issues caused by antipsychotic medications, based on a review of 46 studies.

Preliminary evidence suggests that prebiotic and probiotic treatments may help improve SCZ symptoms and reduce metabolic side effects associated with antipsychotic use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gut microbiome in schizophrenia and antipsychotic-induced metabolic alterations: a scoping review. Singh, R., Stogios, N., Smith, E., et al.[2022]

This study will evaluate the effects of a high prebiotic and probiotic diet on the nutritional and cardio-metabolic health of 50 individuals diagnosed with schizophrenia over a 6-month period, comparing it to conventional dietary advice.

The research aims to demonstrate that dietary modulation with psychobiotics can significantly improve both nutritional status and psychopathological symptoms, potentially establishing it as an effective therapeutic intervention for schizophrenia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of nutrition education for the increase of symbiotic intake on nutritional and metabolic status in schizophrenic spectrum disorders: A two-arm protocol. Sevillano-Jiménez, A., Molina-Recio, G., García-Mellado, JA., et al.[2023]

In a study using fecal cultures from healthy and morbidly obese adults, different prebiotics were tested, revealing that 1-kestose had the most significant impact on gut microbiota composition and metabolic activity.

Prebiotic modulation led to increased Bacteroides and Faecalibacterium in obese individuals, while normal-weight individuals showed higher levels of Bifidobacterium and Faecalibacterium, highlighting the need for tailored prebiotic treatments based on individual microbiota profiles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In Vitro Evaluation of Different Prebiotics on the Modulation of Gut Microbiota Composition and Function in Morbid Obese and Normal-Weight Subjects. Nogacka, AM., Salazar, N., Arboleya, S., et al.[2023]

Inulin, a type of prebiotic, can help reduce anxiety and depression-like behaviors in mice, especially when administered in the morning, suggesting that the timing of prebiotic intake is important for mental health benefits.

A high-fat diet worsens neuroinflammation and increases anxiety and depression symptoms, indicating that dietary patterns significantly influence the effectiveness of prebiotics like inulin in managing stress-related mental disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Administration Time and Dietary Patterns Modified the Effect of Inulin on CUMS-Induced Anxiety and Depression. Chen, P., Li, X., Yu, Y., et al.[2023]

An 8-week randomized controlled trial with 119 adults showed that a high-prebiotic diet significantly reduced total mood disturbance compared to a placebo, indicating its potential efficacy in improving mental health.

Probiotic supplements and the combination of probiotics with a high-prebiotic diet (synbiotics) did not show significant benefits for mental health outcomes, suggesting that prebiotic dietary changes alone may be more effective.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a high-prebiotic diet versus probiotic supplements versus synbiotics on adult mental health: The "Gut Feelings" randomised controlled trial. Freijy, TM., Cribb, L., Oliver, G., et al.[2023]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Modulation of Gut Microbial Diversity through Non-Pharmaceutical Approaches to Treat Schizophrenia. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Can prebiotics assist in the management of cognition and weight gain in schizophrenia? [2019]

3. Switzerland pubmed.ncbi.nlm.nih.gov

The role of probiotics and prebiotics in modulating of the gut-brain axis. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Gut microbiome in schizophrenia and antipsychotic-induced metabolic alterations: a scoping review. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Efficacy of nutrition education for the increase of symbiotic intake on nutritional and metabolic status in schizophrenic spectrum disorders: A two-arm protocol. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

In Vitro Evaluation of Different Prebiotics on the Modulation of Gut Microbiota Composition and Function in Morbid Obese and Normal-Weight Subjects. [2023]

7. Germany pubmed.ncbi.nlm.nih.gov

Administration Time and Dietary Patterns Modified the Effect of Inulin on CUMS-Induced Anxiety and Depression. [2023]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Effects of a high-prebiotic diet versus probiotic supplements versus synbiotics on adult mental health: The "Gut Feelings" randomised controlled trial. [2023]