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Could a gut supplement boost brain health in schizophrenia?

NCT ID NCT05527210

Disease control Sponsor: University of Maryland, Baltimore Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 24, 2026 · Updated 1 time

Summary

This study tests whether a prebiotic supplement (Prebiotin®) can reduce inflammation and improve thinking in people with schizophrenia or schizoaffective disorder. Sixty adults aged 18-60 who are stable on antipsychotics will take the prebiotic or a placebo for 12 weeks. Researchers will measure changes in blood butyrate levels, cognitive test scores, and side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Prebiotin® (a prebiotic dietary supplement)
What this could lead to
If it works, this could point toward a simple, safe way to improve thinking and reduce inflammation in people with schizophrenia.
What could go wrong
This is a small, early-stage trial with only 60 participants. The prebiotic may not change inflammation or cognition, and results may not apply to everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2023

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 60 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Psychotic Disorders schizoaffective disorder schizophrenia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Schizoaffective disorder Schizophrenia

Contacts and locations

Locations

  • Maryland Psyciatric Research Center

    Catonsville, Maryland, 21228, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.