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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if prebiotics, supplements that promote the growth of beneficial gut bacteria, can reduce inflammation and enhance cognitive function in individuals with schizophrenia. Participants will take either a prebiotic (such as Prebiotin or Oligofructose-enriched inulin) or a placebo (a treatment that mimics the real one) mixed with water three times daily for 12 weeks. The trial seeks individuals diagnosed with schizophrenia or schizoaffective disorder who are stable on their current medication and have not experienced major medication changes recently. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could improve future treatment options.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that prebiotic treatments have been studied for their effects on people with schizophrenia. These studies found that prebiotics can increase levels of plasma butyrate, a substance important for gut health. Importantly, these treatments have been tested in people and are generally well-tolerated.

In one study, participants did not report a noticeable increase in side effects after using prebiotics for 12 weeks. This finding suggests that prebiotics are safe for use in this context. While individual experiences can vary, existing evidence supports that prebiotics are usually safe and manageable for those with schizophrenia. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment for schizophrenia?

Researchers are excited about using prebiotics for schizophrenia because they offer a novel approach by potentially influencing gut bacteria to improve mental health. Unlike standard treatments such as antipsychotics, which directly target brain chemistry, prebiotics aim to enhance the gut-brain connection, which might lead to fewer side effects. This new pathway could complement existing treatments, offering a more holistic way to manage schizophrenia symptoms.

What evidence suggests that this trial's treatments could be effective for schizophrenia?

Research shows that people with schizophrenia often have fewer helpful gut bacteria that produce butyrate, which is important for reducing inflammation. Studies have found that prebiotics can increase these beneficial bacteria. In this trial, participants will receive either a prebiotic or a placebo. One study showed that taking prebiotics led to a 15% reduction in psychosis symptoms and a 23% reduction in hostility symptoms in people with schizophrenia. This suggests that prebiotics might help reduce some symptoms of schizophrenia by addressing inflammation. ^{2 4 6 7 8}

Who Is on the Research Team?

Robert Buchanan, M.D.

Principal Investigator

University of Maryland, Baltimore

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39146178/

Prebiotic Treatment in People With Schizophrenia - PubMed Background: Preliminary evidence suggests that people with schizophrenia have decreased relative abundance of butyrate-producing bacteria in the ...

2. clinicaltrial.be clinicaltrial.be/en/details/15022?per_page=20&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

Prebiotic Treatment in People With Schizophrenia The investigators hypothesize that the level of inflammation in people with schizophrenia can be reduced through the use of the prebiotic: ...

3. researchgate.net researchgate.net/publication/383176223_Prebiotic_Treatment_in_People_With_Schizophrenia

Prebiotic Treatment in People With Schizophrenia Studies have shown that schizophrenia patients often exhibit reduced levels of butyrate-producing bacteria. Notably, Buchanan et al. found that supplementation ...

4. nutraceuticals.pharmaceuticalconferences.com nutraceuticals.pharmaceuticalconferences.com/abstract/2020/the-effects-of-prebiotic-treatment-in-schizophrenia-results-of-a-pilot-study

The Effects of Prebiotic Treatment in Schizophrenia ... On the BPRS, we observed a 15% decrease in psychosis and a 23% decrease in hostility symptoms. We observed little to no change in SANS total ...

5. ctv.veeva.com ctv.veeva.com/study/prebiotic-treatment-in-people-with-schizophrenia-pilot-study

Prebiotic Treatment in People With Schizophrenia - Pilot Study There is one published study of gut microbiota in schizophrenia. Shen and colleagues found a significant reduction in butyrate producers in ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11384470/

Prebiotic Treatment in People with Schizophrenia - PMC Prebiotic treatment increases serum butyrate in people with schizophrenia: Results of an open-label inpatient pilot clinical trial. J Clin ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04366401

Efficacy of Prebiotic and Probiotic Dietary Modulation in ... This function provides sufficient evidence to establish a causal relationship between numerous neuropsychiatric disorders, such as schizophrenia. Besides, the ...

8. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05527210/prebiotic-treatment-in-people-with-schizophrenia

Prebiotic Treatment in People With Schizophrenia DSM-5 diagnosis of schizophrenia or schizoaffective disorder; · Age 18-60 years; · Considered clinically stable by the treating psychiatrist;.