Prebiotic Treatment in People With Schizophrenia

Schizophrenia Clinical Trial

— FOCIS  

Official title:

Prebiotic Treatment in People With Schizophrenia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05527210
• Other study ID #: HP-00102648
• Secondary ID: R61AT009990
• Status: Recruiting
• Phase: N/A
• Start date: January 25, 2023
• Est. completion date: January 31, 2026

Study information

• Verified date: May 2024
• Source: University of Maryland, Baltimore
• Contact: Sarah Caimona
• Phone: 410-402-6883
• Email: scaimona[@]som.umaryland.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

Intervention

Dietary Supplement:
• Prebiotic
Prebiotin® is a fine, white to slightly yellow powder, which is mixed into water and has a slightly sweet taste.
• Placebo Prebiotic
Placebo prebiotic mixed into water

Locations

Country	Name	City	State
United States	Maryland Psyciatric Research Center	Catonsville	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
University of Maryland, Baltimore	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

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