Prebiotic Treatment in People With Schizophrenia

NCT ID: NCT05527210

Last Updated: 2025-09-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-25
• Study Completion Date: 2026-01-31

Brief 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.

Detailed 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.

Conditions

Schizophrenia; Schizoaffective Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

Active Study Med

Participants randomized to active study medication will mix 4g of powder prebiotic with water, 3 times a day for 12 weeks.

Group Type: ACTIVE_COMPARATOR

Prebiotic

Intervention Type: DIETARY_SUPPLEMENT

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

Placebo

Participants randomized to active study medication will mix 4g of powder placebo with water, 3 times a day for 12 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo Prebiotic

Intervention Type: DIETARY_SUPPLEMENT

Placebo prebiotic mixed into water

Interventions

Prebiotic

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

Intervention Type: DIETARY_SUPPLEMENT

Placebo Prebiotic

Placebo prebiotic mixed into water

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Prebiotin®; maltodextrin

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role: collaborator

University of Maryland, Baltimore

OTHER

Sponsor Role: lead

Responsible Party

Robert Buchanan

Chief, Maryland Psychiatric Research Center, Outpatient Research Program

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Robert Buchanan, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Maryland, Baltimore

Locations

Maryland Psyciatric Research Center

Catonsville, Maryland, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Matt Glassman

Role: CONTACT

MGlassman@som.umaryland.edu

410-402-6411

Jennifer Zaranski, MA

Role: CONTACT

jzaranski@som.umaryland.edu

410-402-6060

Facility Contacts

Matt Glassman

Role: primary

MGlassman@som.umaryland.edu

410-402-6411

Jennifer Zaranski, MA

Role: backup

jzaranski@som.umaryland.edu

410-402-6060

Other Identifiers

R61AT009990

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HP-00102648

Identifier Type: -

Identifier Source: org_study_id