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. (GLUCOPSICO)

Manuel Jesús Cuesta Zurita

Status: Active, not recruiting

Conditions: Metabolic Abnormalities; Postbiotic Supplement; SCHIZOPHRENIA 1 (Disorder)

Treatments: Dietary Supplement: Pediococcus acidilactici, pA1c®HI postbiotic supplementation taking participants; Drug: Atypical antipsychotics (AAP)

Study type: Interventional

Funder types: Other

Identifiers

NCT07371325

GLUCOPSICOBIOMICS_2025

Details and patient eligibility

About

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.

Full 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).

Enrollment: 36 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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36 participants in 4 patient groups, including a placebo group

FEP and postbiotic

Experimental group

Description:

Participants with FEP diagnostic taking postbiotic and atypical antipsychotics

Treatment:

Drug: Atypical antipsychotics (AAP)

Dietary Supplement: Pediococcus acidilactici, pA1c®HI postbiotic supplementation taking participants

SSD and postbiotic

Experimental group

Description:

Participants with SSD diagnostic taking postbiotic and atypical antipsychotics

Treatment:

Drug: Atypical antipsychotics (AAP)

Dietary Supplement: Pediococcus acidilactici, pA1c®HI postbiotic supplementation taking participants

FEP and placebo

Placebo Comparator group

Description:

Participants with FEP diagnostic taking placebo and atypical antipsychotics

Treatment:

Drug: Atypical antipsychotics (AAP)

SSD and placebo

Placebo Comparator group

Description:

Participants with SSD diagnostic taking placebo and atypical antipsychotics

Treatment:

Drug: Atypical antipsychotics (AAP)