Schizophrenia Clinical Trial
— FOCISOfficial title:
Prebiotic Treatment in People With Schizophrenia
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.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | January 31, 2026 |
Est. primary completion date | January 31, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Maryland Psyciatric Research Center | Catonsville | Maryland |
Lead Sponsor | Collaborator |
---|---|
University of Maryland, Baltimore | National Center for Complementary and Integrative Health (NCCIH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in serum butyrate levels | Number of participants with an increase in serum butyrate levels at 12 weeks. | 12 weeks | |
Primary | Cognition | Number of participants with an increase in MCCB composite score at 12 weeks. | 12 weeks | |
Primary | Incidence of Side Effects | Number of participants with an increased incidence of side effects at 12 weeks. | 12 weeks | |
Secondary | Change in Affective Symptoms | Number of participants with an increase in affective symptoms at 12 weeks, measured by the Calgary Depression Scale (CDS). | 12 weeks | |
Secondary | Change in Positive Symptoms | Number of participants with an increase in positive symptoms at 12 weeks, measured by the Brief Psychiatric Rating Scale (BPRS). | 12 weeks | |
Secondary | Change in Negative Symptoms | Number of participants with an increase in negative symptoms at 12 weeks, measured by the • Scale for the Assessment of Negative Symptoms (SANS). | 12 weeks | |
Secondary | Changes in Serum Measurements | Number of participants with an increase in fasting levels of serum glucose, triglycerides, and/or cholesterol at 12 weeks. | 12 weeks | |
Secondary | Effects of Gut Composition | Number of participants with an increase in cytokine, gut permeability, or gut microbiota composition levels at 12 weeks. | 12 weeks |
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