deltatrials
Completed INTERVENTIONAL NCT07371325

Efficacy of Pediococcus Acidilactici as add-on to Antipsychotic Drugs on Metabolic Syndrome Disturbances in First-episode Psychosis and Schizophrenia Spectrum Disorders. (GLUCOPSICO)

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.

Sponsor: GENBIOMA Aplicaciones SL

Conditions Metabolic Abnormalities Postbiotic Supplement SCHIZOPHRENIA 1 (Disorder)
Interventions Atypical antipsychotics (AAP) Pediococcus acidilactici, pA1c®HI postbiotic supplementation taking participants
Updated 2 times since 2026 Last updated: Apr 13, 2026 Started: Sep 8, 2024 Primary completion: Jan 23, 2026 Completion: Jan 23, 2026
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A observational or N/A phase clinical study on Metabolic Abnormalities and Postbiotic Supplement, this trial is completed. The trial is conducted by GENBIOMA Aplicaciones SL and has accumulated 2 data snapshots since 2024. Psychiatric clinical trials are essential for establishing evidence-based treatment standards.

Study Description(click to expand)

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).

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).

Status Flow

~Feb 2026 – ~Apr 2026 · 2 months · monthly snapshotActive Not RecruitingApr 17, 2026 – present · 5 months · daily APICompleted

Change History

2 versions recorded

  1. Apr 17, 2026 — Present [daily]

    Completed

    Status: Active Not Recruiting → Completed · Phase: NA → None

  2. Feb 2026 — Apr 2026 [monthly]

    Active Not Recruiting NA

    First recorded

Sep 2024

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility 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.

Contact Information

Sponsor contact:
  • GENBIOMA Aplicaciones SL
  • Manuel Jesús Cuesta Zurita
  • Universidad Pública de Navarra
Data source: ClinicalTrials.gov

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations