Prebiotics for Schizophrenia
(FOCIS Trial)
Recruiting in Palo Alto (17 mi)
Overseen ByRobert Buchanan, M.D.
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Maryland, Baltimore
Must be taking: Antipsychotics
Must not be taking: Antibiotics, Immune therapy
Disqualifiers: Gastrointestinal disorders, Brain disorder, others
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.
12345Is 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.
12467How 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.
12348Eligibility 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 between 18 and 60 years old.
I am on a stable dose of antipsychotic medication for the past 14 days.
Considered clinically stable by the treating psychiatrist
+3 more
Exclusion Criteria
Pregnant or lactation secondary to pregnancy
I am currently taking antibiotics.
Intellectual disability
+7 more
Trial 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
Participant Groups
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.
2Treatment groups
Active Control
Placebo Group
Group I: Active Study MedActive Control1 Intervention
Participants randomized to active study medication will mix 4g of powder prebiotic with water, 3 times a day for 12 weeks.
Group II: PlaceboPlacebo Group1 Intervention
Participants randomized to active study medication will mix 4g of powder placebo with water, 3 times a day for 12 weeks.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Maryland Psyciatric Research CenterCatonsville, MD
Loading ...
Who Is Running the Clinical Trial?
University of Maryland, BaltimoreLead Sponsor
National Center for Complementary and Integrative Health (NCCIH)Collaborator
References
Modulation of Gut Microbial Diversity through Non-Pharmaceutical Approaches to Treat Schizophrenia. [2022]Schizophrenia (SCZ) is a psychotic syndrome with well-defined signs and symptoms but indecisive causes and effective treatment. Unknown underpinning reasons and no cure of the disease profoundly elevate the risk of illness. Gut microbial dysbiosis related metabolic dysfunction is providing a new angle to look at the potential causes and treatment options for schizophrenia. Because of the number of side effects, including gut dysbiosis, of traditional antipsychotic drugs, new alternative therapeutic options are under consideration. We propose that non-pharmacotherapy using biotherapeutic products could be a potent treatment to improve cognitive impairment and other symptoms of schizophrenia. Use of live microorganisms (probiotics), fibers (prebiotics), and polyphenols alone or in a mixture can maintain gut microbial diversity and improve the two-way relationship of the gut microbiota and the central nervous system. Fiber and polyphenol induced management of gut microbiota may positively influence the gut-brain axis by increasing the level of brain-derived neurotrophic factors involved in schizophrenia. Furthermore, we endorse the need for comprehensive clinical assessment and follow-up of psychobiotic (pro and prebiotics) treatment in mental illness to estimate the level of target recovery and disability reduction in schizophrenia.
Can prebiotics assist in the management of cognition and weight gain in schizophrenia? [2019]Schizophrenia is among the top half of the 25 leading causes of disabilities worldwide with a 10-20 year decrease in life expectancy. Ineffective pharmacotherapy in the management of cognitive deficits and weight gain are known to be significant contributors; therefore interventions that may mitigate one, or both, of these parameters would be highly beneficial. Manipulation of the gut microbiome using dietary supplements such as prebiotics may be one such intervention. Preclinical studies have shown that a 2-4 week dietary supplementation with a prebiotic has beneficial effects on learning and memory, and prevents pro-inflammatory signals that are detrimental to cognitive processes. Furthermore, prebiotics influence metabolism, and in obesity they increase the expression of anorexigenic gut hormones such as peptide tyrosine tyrosine, glucagon-like peptide 1 and leptin, as well as decrease levels of orexigenic hormones such as ghrelin. Despite compelling evidence for the pro-cognitive and neuroprotective effects of prebiotics in rodents, their ability to alleviate cognitive deficits or enhance cognition needs to be evaluated in humans. Here we suggest that important symptoms associated with schizophrenia, such as cognitive impairment and weight gain, may benefit from concurrent prebiotic therapy.
The role of probiotics and prebiotics in modulating of the gut-brain axis. [2023]Pro-and prebiotics have been indicated to modulate the gut-brain axis, which have supportive impacts on central nervous systems, and decrease or control the incidence of some mental disorders such as depression, anxiety, autism, Schizophrenia, and Alzheimer's. In this review, complex communications among microbiota, gut, and the brain, and also recent scientific findings of the impacts and possible action mechanisms of pro-and prebiotics on mental disorders have been discussed. The results have shown that pro-and prebiotics can improve the function of central nervous system and play an important role in the prevention and treatment of some brain disorders; however, in order to prove these effects conclusively and firmly and to use these compounds in a therapeutic and supportive way, more studies are needed, especially human studies/clinical trials.
Gut microbiome in schizophrenia and antipsychotic-induced metabolic alterations: a scoping review. [2022]Schizophrenia (SCZ) is a severe mental disorder with high morbidity and lifetime disability rates. Patients with SCZ have a higher risk of developing metabolic comorbidities such as obesity and diabetes mellitus, leading to increased mortality. Antipsychotics (APs), which are the mainstay in the treatment of SCZ, increase the risk of these metabolic perturbations. Despite extensive research, the mechanism underlying SCZ pathophysiology and associated metabolic comorbidities remains unclear. In recent years, gut microbiota (GMB) has been regarded as a 'chamber of secrets', particularly in the context of severe mental illnesses such as SCZ, depression, and bipolar disorder. In this scoping review, we aimed to investigate the underlying role of GMB in the pathophysiology of SCZ and metabolic alterations associated with APs. Furthermore, we also explored the therapeutic benefits of prebiotic and probiotic formulations in managing SCZ and AP-induced metabolic alterations. A systematic literature search yielded 46 studies from both preclinical and clinical settings that met inclusion criteria for qualitative synthesis. Preliminary evidence from preclinical and clinical studies indicates that GMB composition changes are associated with SCZ pathogenesis and AP-induced metabolic perturbations. Fecal microbiota transplantation from SCZ patients to mice has been shown to induce SCZ-like behavioral phenotypes, further supporting the plausible role of GMB in SCZ pathogenesis. This scoping review recapitulates the preclinical and clinical evidence suggesting the role of GMB in SCZ symptomatology and metabolic adverse effects associated with APs. Moreover, this scoping review also discusses the therapeutic potentials of prebiotic/probiotic formulations in improving SCZ symptoms and attenuating metabolic alterations related to APs.
Efficacy of nutrition education for the increase of symbiotic intake on nutritional and metabolic status in schizophrenic spectrum disorders: A two-arm protocol. [2023]The microbiota plays a vital role in the two-way communication between the gastrointestinal tract and numerous neuropsychiatric disorders, such as schizophrenia. Besides, the microbiota modulation through the use of psychobiotics (prebiotics and probiotics with nutraceutical action) is related to the improvement of the physical and psychopathological health. The objective to this study was to test the efficacy of prebiotic/probiotic dietary modulation in patients diagnosed with schizophrenia, attending to the nutritional and cardio-metabolic impact.
In Vitro Evaluation of Different Prebiotics on the Modulation of Gut Microbiota Composition and Function in Morbid Obese and Normal-Weight Subjects. [2023]The gut microbiota remains relatively stable during adulthood; however, certain intrinsic and environmental factors can lead to microbiota dysbiosis. Its restoration towards a healthy condition using best-suited prebiotics requires previous development of in vitro models for evaluating their functionality. Herein, we carried out fecal cultures with microbiota from healthy normal-weight and morbid obese adults. Cultures were supplemented with different inulin-type fructans (1-kestose, Actilight, P95, Synergy1 and Inulin) and a galactooligosaccharide. Their impact on the gut microbiota was assessed by monitoring gas production and evaluating changes in the microbiota composition (qPCR and 16S rRNA gene profiling) and metabolic activity (gas chromatography). Additionally, the effect on the bifidobacterial species was assessed (ITS-sequencing). Moreover, the functionality of the microbiota before and after prebiotic-modulation was determined in an in vitro model of interaction with an intestinal cell line. In general, 1-kestose was the compound showing the largest effects. The modulation with prebiotics led to significant increases in the Bacteroides group and Faecalibacterium in obese subjects, whereas in normal-weight individuals, substantial rises in Bifidobacterium and Faecalibacterium were appreciated. Notably, the results obtained showed differences in the responses among the tested compounds but also among the studied human populations, indicating the need for developing population-specific products.
Administration Time and Dietary Patterns Modified the Effect of Inulin on CUMS-Induced Anxiety and Depression. [2023]Prebiotics exert anxiolytic and antidepressant effects through the microbiota-gut-brain axis in animal models. However, the influence of prebiotic administration time and dietary pattern on stress-induced anxiety and depression is unclear. In this study, whether administration time can modify the effect of inulin on mental disorders within normal and high-fat diets are investigated.
Effects of a high-prebiotic diet versus probiotic supplements versus synbiotics on adult mental health: The "Gut Feelings" randomised controlled trial. [2023]Preliminary evidence supports the use of dietary interventions and gut microbiota-targeted interventions such as probiotic or prebiotic supplementation for improving mental health. We report on the first randomised controlled trial (RCT) to examine the effects of a high-prebiotic dietary intervention and probiotic supplements on mental health.