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

NCT07371325 | Completed

• 1 other identifier: GLUCOPSICOBIOMICS_2025
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

SCHIZOPHRENIA 1 (Disorder); Metabolic Abnormalities; Postbiotic Supplement

Keywords

Schizophrenia; First-episode psychosis; Metabolic Syndrome; Postbiotic; Atypical antipsychotics

Outcome Measures

Primary Outcomes (8)

• Metabolic Disturbances

  1\. Total cholesterol Description: Measurement of total cholesterol in the blood. Includes LDL, HDL, and other fractions. It is a general marker of cardiovascular risk. Units: mg/dL Ranges: Desirable: \< 200 mg/dL High limit: 200-239 mg/dL High: ≥ 240 mg/dL

  Beginning (week 0) and end of the study (week 12).

• Metabolic Disturbances

  2\. LDL cholesterol (Low-Density Lipoprotein) Description: Known as "bad cholesterol." High levels are associated with atherosclerosis and cardiovascular disease. Units: mg/dL Ranges: Optimal: \< 100 mg/dL Near optimal: 100-129 mg/dL High limit: 130-159 mg/dL High: 160-189 mg/dL Very high: ≥ 190 mg/dL

  Beginning (week 0) and end of the study (week 12)

• Metabolic Disturbances

  3\. HDL cholesterol (High-Density Lipoprotein) Description: Known as "good cholesterol." Helps remove cholesterol from the arteries. Units: mg/dL Ranges: Low (cardiovascular risk): Men: \< 40 mg/dL Women: \< 50 mg/dL Adequate/protective: ≥ 60 mg/dL

  Beginning (week 0) and end of the study (week 12)

• Metabolic Disturbances

  4\. Triglycerides Description: Type of fat in the blood related to energy metabolism. High values are associated with metabolic syndrome and cardiovascular risk. Units: mg/dL Ranges (fasting): Normal: \< 150 mg/dL High limit: 150-199 mg/dL High: 200-499 mg/dL Very high: ≥ 500 mg/dL

  Beginning (week 0) and end of the study (week 12)

• Metabolic Disturbances

  5\. Plasma glucose Description: Blood glucose concentration, a key indicator of carbohydrate metabolism. Units: mg/dL Ranges (fasting): Normal: 70-99 mg/dL Impaired fasting glucose (prediabetes): 100-125 mg/dL Diabetes: ≥ 126 mg/dL

  Beginning (week 0) and end of the study (week 12)

• Metabolic Disturbances

  6\. Insulin Description: Hormone produced by the pancreas that regulates glucose uptake by tissues. Units: µU/mL (or mIU/L) Ranges (fasting): Approximate normal: 2-25 µU/mL Elevated values may suggest insulin resistance.

  Beginning (week 0) and end of the study (week 12)

• Metabolic Disturbances

  7\. Glycosylated hemoglobin (HbA1c) Description: Reflects the average blood glucose level over the past 2-3 months. Units: % Ranges: Normal: \< 5.7% Prediabetes: 5.7-6.4% Diabetes: ≥ 6.5%

  Beginning (week 0) and end of the study (week 12)

• Metabolic Disturbances

  8\. HOMA-R (or HOMA-IR) Description: Index that estimates insulin resistance, calculated from fasting glucose and insulin. Formula: HOMA-IR = Insulin (µU/mL) × Glucose (mg/dL) / 405 Units: No units (index) Guideline ranges: Normal: \< 2.0 Mild insulin resistance: 2.0-2.9 Significant insulin resistance: ≥ 3.0

  Beginning (week 0) and end of the study (week 12)

Secondary Outcomes (14)

• Clinical Measures

  Along the study: week 0, week 6, and week 12

• Clinical Measures

  Along the study: week 0, week 6, and week 12

• Clinical Measures

  Along the study: week 0, week 6, and week 12

• Clinical measures

  Along the study: week 0, week 6, and week 12

• Clinical Measures

  Along the study: week 0, week 6, and week 12

Study Arms (4)

FEP and postbiotic

EXPERIMENTAL

Participants with FEP diagnostic taking postbiotic and atypical antipsychotics

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

SSD and postbiotic

EXPERIMENTAL

Participants with SSD diagnostic taking postbiotic and atypical antipsychotics

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

FEP and placebo

PLACEBO COMPARATOR

Participants with FEP diagnostic taking placebo and atypical antipsychotics

Drug: Atypical antipsychotics (AAP)

SSD and placebo

PLACEBO COMPARATOR

Participants with SSD diagnostic taking placebo and atypical antipsychotics

Drug: Atypical antipsychotics (AAP)

Interventions

Pediococcus acidilactici, pA1c®HI postbiotic supplementation taking participants DIETARY_SUPPLEMENT

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

FEP and postbiotic; SSD and postbiotic

Atypical antipsychotics (AAP) DRUG

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.

FEP and placebo; FEP and postbiotic; SSD and placebo; SSD and postbiotic

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad Pública de Navarra: collaborator
• Manuel Jesús Cuesta Zurita: lead
• GENBIOMA Aplicaciones SL: collaborator

Study Sites (1)

Navarrabiomed

Pamplona, Navarre, 31012, Spain

Location

Related Publications (4)

• Kang, D., Zhang, F., Yang, Y., Liu, C., Xiao, J., Long, Y., Huang, J., Peng, X., Wang, W., Wang, X., Davis, J. M., Zhao, J., & Wu, R. (2021). Probiotic supplements reduce antipsychotic-induced metabolic disturbances in drug-naïve first-episode schizophrenia. https://doi.org/10.1101/2021.02.16.21251872

  BACKGROUND

• Pillinger, T., McCutcheon, R. A., Vano, L., Mizuno, Y., Arumuham, A., Hindley, G., Beck, K., Natesan, S., Efthimiou, O., Cipriani, A., & Howes, O. D. (2020). Comparative effects of 18 antipsychotics on metabolic function in patients with schizophrenia, predictors of metabolic dysregulation, and association with psychopathology: a systematic review and network meta-analysis. The Lancet Psychiatry, 7(1), 64-77. https://doi.org/10.1016/S2215-0366(19)30416-X

  BACKGROUND

• Tomasik, J., Lago, S. G., Vázquez-Bourgon, J., Papiol, S., Suárez-Pinilla, P., Crespo-Facorro, B., & Bahn, S. (2019). Association of Insulin Resistance With Schizophrenia Polygenic Risk Score and Response to Antipsychotic Treatment. JAMA Psychiatry, 76(8), 864. https://doi.org/10.1001/jamapsychiatry.2019.0304

  BACKGROUND

• Yavorov-Dayliev, D., Milagro, F. I., Ayo, J., Oneca, M., & Aranaz, P. (2022). Pediococcus acidilactici CECT9879 (pA1c) Counteracts the Effect of a High-Glucose Exposure in C. elegans by Affecting the Insulin Signaling Pathway (IIS). International Journal of Molecular Sciences, 23(5), 2689. https://doi.org/10.3390/ijms23052689

  BACKGROUND

MeSH Terms

Conditions

Schizophrenia; Metabolic Syndrome

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: A double-blind placebo-controlled trial
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PSYCHIATRIST

Study Record Dates

• First Submitted: January 8, 2026
• First Posted: January 27, 2026
• Study Start: September 8, 2024
• Primary Completion: January 23, 2026
• Study Completion: January 23, 2026
• Last Updated: April 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)