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Gut bacteria may tame antipsychotic side effects in schizophrenia

NCT ID NCT07371325

Disease control Sponsor: Manuel Jesús Cuesta Zurita 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tested whether a probiotic supplement (Pediococcus acidilactici) could reduce metabolic problems like high cholesterol and blood sugar caused by antipsychotic drugs. 36 adults with first-episode psychosis or schizophrenia took the probiotic or a placebo alongside their regular medication. The goal was to see if the probiotic could improve heart health markers without changing the psychiatric treatment.

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

36 people

The number who actually took part.

Started

Sep 2024

Finished

Jan 2026

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 65 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: * Diagnosis of PEP or TEESQ, according to DSM 5 criteria, aged between 18 and 65 years * Having received antipsychotic treatment for at least 8 weeks before starting the study Exclusion Criteria: * Inability to give informed consent, lack of a representative or legal guardian capable of giving consent * Intellectual disability * Clinically significant medical condition (congestive heart failure, liver disease, renal failure, acute pancreatitis, cancer undergoing active treatment, HIV, or other immunodeficiency) * Active substance use in the last 3 months (except nicotine) * Antibiotic medication in the previous 14 days * Celiac disease * Pregnancy or breastfeeding

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Conditions

The condition(s) this trial relates to.

metabolic disease metabolic syndrome X schizophrenia schizophrenia 1

As listed by the trial registrant

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

Metabolic abnormalities Postbiotic supplement Schizophrenia 1 (disorder)

Contacts and locations

Locations

  • Navarrabiomed

    Pamplona, Navarre, 31012, Spain

More trials for these conditions

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