Prebiotic Treatment in People With Schizophrenia

N/AActive Not RecruitingNCT05527210

University of Maryland, Baltimore60 enrolled

Overview

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.

The investigators hypothesize that the level of inflammation in people with schizophrenia can be reduced through the use of the prebiotic: Prebiotin®, an oligofructose-enriched inulin (OEI), to stimulate the activity of butyrate-producing bacteria and increase the production of butyrate, which has multiple anti-inflammatory properties. The investigators will confirm the effect of prebiotic administration on the biological signature and examine whether increased serum butyrate levels are associated with changes in cognitive performance (primary specific aim), symptoms, and metabolic measures; and the extent to which these associations are mediated by the anti-inflammatory properties of butyrate, including the ability of butyrate to decrease gut permeability and inhibit the production of pro-inflammatory cytokines, and/or changes in gut microbiota composition. In a sample of participants with a DSM-5 diagnosis of schizophrenia or schizoaffective disorder, the investigators will conduct a 12-week, double-blind, placebo-controlled, randomized clinical trial to confirm the effect of prebiotic administration on the biological signature and examine whether increased serum butyrate levels are associated with changes in cognitive performance, symptoms, and metabolic measures; and the extent to which these associations are mediated by the anti-inflammatory properties of butyrate, including the ability of butyrate to decrease gut permeability and inhibit the production of pro-inflammatory cytokines, and/or changes in gut microbiota composition.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

QUADRUPLE

Enrollment

Conditions

Schizophrenia Schizoaffective Disorder

Interventions

PrebioticDIETARY_SUPPLEMENT

Prebiotin® is a fine, white to slightly yellow powder, which is mixed into water and has a slightly sweet taste.

Placebo PrebioticDIETARY_SUPPLEMENT

Placebo prebiotic mixed into water

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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.

Locations (1)

Maryland Psyciatric Research Center

Catonsville, Maryland, United States

Outcomes

Primary Outcomes

Change in serum butyrate levels

Number of participants with an increase in serum butyrate levels at 12 weeks.

Time frame: 12 weeks

Cognition

Number of participants with an increase in MCCB composite score at 12 weeks.

Time frame: 12 weeks

Incidence of Side Effects

Number of participants with an increased incidence of side effects at 12 weeks.

Time frame: 12 weeks

Secondary Outcomes

Change in Affective Symptoms

Number of participants with an increase in affective symptoms at 12 weeks, measured by the Calgary Depression Scale (CDS).

Time frame: 12 weeks

Change in Positive Symptoms

Number of participants with an increase in positive symptoms at 12 weeks, measured by the Brief Psychiatric Rating Scale (BPRS).

Time frame: 12 weeks

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).

Time frame: 12 weeks

Changes in Serum Measurements

Number of participants with an increase in fasting levels of serum glucose, triglycerides, and/or cholesterol at 12 weeks.

Time frame: 12 weeks

Effects of Gut Composition

Number of participants with an increase in cytokine, gut permeability, or gut microbiota composition levels at 12 weeks.

Data from ClinicalTrials.gov

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