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Efficacy of Pediococcus Acidilactici as add-on to Antipsychotic Drugs on Metabolic Syndrome Disturbances in First-episode Psychosis and Schizophrenia Spectrum Disorders. A Double-blind Placebo-controlled Trial. | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGNA

Efficacy of Pediococcus Acidilactici as add-on to Antipsychotic Drugs on Metabolic Syndrome Disturbances in First-episode Psychosis and Schizophrenia Spectrum Disorders. A Double-blind Placebo-controlled Trial.

NCT07371325•Manuel Jesús Cuesta Zurita

View on ClinicalTrials.gov

Summary

The aim of the present study is to evaluate the effectiveness of the addition of the postbiotic Pediococcus acidilactici (pA1c®HI) on amelioration of metabolic disturbances in patients with (FEP) or (SSD) treated with antipsychotic drugs.

Detailed Description

This study aims to evaluate the effectiveness of an add-on postbiotic (Pediococcus acidilactici, pA1c®HI) to antipsychotic drugs on metabolic disturbances and psychopathological dimensions in patients diagnosed with first episode psychotic (FEP) or schizophrenia spectrum disorder (SSD).

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

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

Locations (1)

Navarrabiomed

Pamplona, Navarre, Spain

Key Dates

Start Date

September 8, 2024

Primary Completion Date

January 23, 2026

Completion Date

January 23, 2026

Last Updated

January 27, 2026

Enrollment

ACTUAL participants

Conditions

SCHIZOPHRENIA 1 (Disorder)Metabolic AbnormalitiesPostbiotic Supplement

Interventions

Pediococcus acidilactici, pA1c®HI postbiotic supplementation taking participants

DIETARY_SUPPLEMENT

Atypical antipsychotics (AAP)

DRUG

High Phenolic Olive Oil for Enhancing Metabolic Health: a Randomized-controlled Trial in Patients With cEntral Obesity (HOPE)

NCT07445503

AdultsOverweight , Obesity+2 more

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RECRUITINGNA

PS-Trauma - Development of Trauma Treatment for Patients With Co-morbid Psychotic Disorders and Traumas

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SCHIZOPHRENIA 1 (Disorder)Schizotypal Disorder+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 27, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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