NCT05527210

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable schizophrenia

Timeline
8mo left

Started Jan 2023

Typical duration for not_applicable schizophrenia

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress83%
Jan 2023Dec 2026

First Submitted

Initial submission to the registry

August 30, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 2, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

January 25, 2023

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

March 9, 2026

Status Verified

March 1, 2026

Enrollment Period

3.9 years

First QC Date

August 30, 2022

Last Update Submit

March 5, 2026

Conditions

SchizophreniaSchizoaffective Disorder

Outcome Measures

Primary Outcomes (3)

  • Change in serum butyrate levels

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

    12 weeks

  • Cognition

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

    12 weeks

  • Incidence of Side Effects

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

    12 weeks

Secondary Outcomes (5)

  • Change in Affective Symptoms

    12 weeks

  • Change in Positive Symptoms

    12 weeks

  • Change in Negative Symptoms

    12 weeks

  • Changes in Serum Measurements

    12 weeks

  • Effects of Gut Composition

    12 weeks

Study Arms (2)

Active Study Med

ACTIVE COMPARATOR

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

Dietary Supplement: Prebiotic

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo Prebiotic

Interventions

PrebioticDIETARY_SUPPLEMENT

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

Also known as: Prebiotin®
Active Study Med
Placebo PrebioticDIETARY_SUPPLEMENT

Placebo prebiotic mixed into water

Also known as: maltodextrin
Placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maryland Psyciatric Research Center

Catonsville, Maryland, 21228, United States

RECRUITING

MeSH Terms

Conditions

SchizophreniaPsychotic Disorders

Interventions

Prebioticsmaltodextrin

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Dietary FiberDietary CarbohydratesCarbohydratesPolysaccharides, BacterialPolysaccharidesFoodDiet, Food, and NutritionPhysiological PhenomenaDietary SupplementsFood and Beverages

Study Officials

  • Robert Buchanan, M.D.

    University of Maryland, Baltimore

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Matt Glassman

CONTACT

410-402-6411MGlassman@som.umaryland.edu

Jennifer Zaranski, MA

CONTACT

410-402-6060jzaranski@som.umaryland.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief, Maryland Psychiatric Research Center, Outpatient Research Program

Study Record Dates

First Submitted

August 30, 2022

First Posted

September 2, 2022

Study Start

January 25, 2023

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

March 9, 2026

Record last verified: 2026-03

Locations

US(1)