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Active, Not Recruiting

NCT Number: NCT05527210

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maryland Psyciatric Research Center

Catonsville, Maryland, 21228, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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
  • Organic brain disorder, including cerebrovascular accident; epilepsy; traumatic brain injury, Loss of consciousness (LOC) for more than 30 minutes
  • Intellectual disability
  • Acute antibiotic use
  • Immune therapy within the last three months
  • Prebiotic or probiotic treatment within the last three months
  • Inability to understand English
  • Inability to cooperate with study procedures
  • Pregnant or lactation secondary to pregnancy
  • 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.

Treatment and study plan

Prebiotic

Dietary Supplement

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

Other names: Prebiotin®

Placebo Prebiotic

Dietary Supplement

Placebo prebiotic mixed into water

Other names: maltodextrin

Primary outcomes

  1. Change in serum butyrate levels

    Time frame: 12 weeks

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

  2. Cognition

    Time frame: 12 weeks

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

  3. Incidence of Side Effects

    Time frame: 12 weeks

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

Secondary outcomes

  1. Change in Affective Symptoms

    Time frame: 12 weeks

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

  2. Change in Positive Symptoms

    Time frame: 12 weeks

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

  3. Change in Negative Symptoms

    Time frame: 12 weeks

    Number of participants with an increase in negative symptoms at 12 weeks, measured by the • Scale for the Assessment of Negative Symptoms (SANS).

  4. Changes in Serum Measurements

    Time frame: 12 weeks

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

  5. Effects of Gut Composition

    Time frame: 12 weeks

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

Sponsors and collaborators

Lead sponsor

University of Maryland, Baltimore

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Acronym: FOCIS

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Sep 2, 2022
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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