Using prebiotics to treat schizophrenia

Prebiotic Treatment in People With Schizophrenia

This study is testing if a prebiotic treatment can help people with schizophrenia or schizoaffective disorder by reducing inflammation and improving their symptoms over 12 weeks.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: University of Maryland, Baltimore (Academic / other)
• Locations: 1 site (Catonsville, Maryland)
• Trial ID: NCT05527210 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effects of a prebiotic treatment, Prebiotin®, on individuals diagnosed with schizophrenia or schizoaffective disorder. The study aims to reduce inflammation associated with these conditions by stimulating the production of butyrate, a compound known for its anti-inflammatory properties. Participants will be randomly assigned to receive either the prebiotic or a placebo over a 12-week period, with assessments of cognitive performance, symptoms, and metabolic measures to determine the treatment's efficacy. The trial will also explore the relationship between butyrate levels and changes in gut microbiota composition.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-60 with a DSM-5 diagnosis of schizophrenia or schizoaffective disorder who are clinically stable and currently on antipsychotic medication.

Not a fit: Patients with gastrointestinal disorders or other significant health issues that could interfere with the treatment or its assessment may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a novel approach to alleviating cognitive impairments and other symptoms in patients with schizophrenia.

How similar studies have performed: While the approach of using prebiotics in this context is relatively novel, there is emerging evidence suggesting potential benefits of gut microbiota modulation in mental health conditions.

Eligibility criteria

Inclusion Criteria:

1. DSM-5 diagnosis of schizophrenia or schizoaffective disorder;
2. Age 18-60 years;
3. Considered clinically stable by the treating psychiatrist;
4. Currently treated with an antipsychotic, with no dose changes in last 14 days;
5. Ability to participate in the informed consent process, as determined by a score of 10 or greater on the Evaluation to Sign Consent;
6. BMI ≤ 40

Exclusion Criteria:

1. Gastrointestinal disorders, including, but not limited to Crohn's Disease, Irritable Bowel Syndrome, Celiac Disease, whose pathology or treatment could alter the presentation or treatment of schizophrenia or significantly increase the risk associated with the proposed treatment protocol
2. Organic brain disorder, including cerebrovascular accident; epilepsy; traumatic brain injury, Loss of consciousness (LOC) for more than 30 minutes
3. Intellectual disability
4. Acute antibiotic use
5. Immune therapy within the last three months
6. Prebiotic or probiotic treatment within the last three months
7. Inability to understand English
8. Inability to cooperate with study procedures
9. Pregnant or lactation secondary to pregnancy
10. Participants who meet DSM 5 criteria for alcohol or substance misuse (except caffeine and nicotine) within the last 3 months will be excluded. Participants who meet DSM 5 criteria for marijuana misuse - mild will be included in the study.

Where this trial is running

Catonsville, Maryland

• Maryland Psyciatric Research Center — Catonsville, Maryland, United States (Recruiting)

Study contacts

• Principal investigator: Robert Buchanan, M.D. — University of Maryland, Baltimore
• Study coordinator: Matt Glassman

Conditions Schizophrenia; Schizoaffective Disorder