NCT07371325

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

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Manuel Jesús Cuesta Zurita · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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).

Conditions

• SCHIZOPHRENIA 1 (Disorder)
• Metabolic Abnormalities
• Postbiotic Supplement

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Pediococcus acidilactici, pA1c®HI postbiotic supplementation taking participants	This study is the first study based on postbiotics instead of probiotics, pA1C®HI will be included as add on to the treatment with atypical antipsychotics in patients diagnosed with FEP or SSD. We include in our study the monitoring of glucose levels by means of sensors that will allow not only the recording of these average daily and weekly glucose levels but also the physical activity performed by the participant along the whole study. We also analyze the microbiota, responsible for metabolic functions, through metatranscriptome of intestinal microbiota from faecal samples from participants
DRUG	Atypical antipsychotics (AAP)	This study participants will continue with their established drug treatment as prescribed by their referring therapists. In the event of any changes to the treatment, the appropriate record will be made.

Timeline

• Start date: 2024-09-08
• Primary completion: 2026-01-23
• Completion: 2026-01-23
• First posted: 2026-01-27
• Last updated: 2026-04-16

Locations

1 site across 1 country: Spain