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Completed

NCT Number: NCT07371325

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Navarrabiomed

Pamplona, Navarre, 31012, Spain

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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.

Primary outcomes

  1. Metabolic Disturbances

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

    • 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

  2. Metabolic Disturbances

    Time frame: Beginning (week 0) and end of the study (week 12)

    • 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

  3. Metabolic Disturbances

    Time frame: Beginning (week 0) and end of the study (week 12)

    • 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

  4. Metabolic Disturbances

    Time frame: Beginning (week 0) and end of the study (week 12)

    • 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

  5. Metabolic Disturbances

    Time frame: Beginning (week 0) and end of the study (week 12)

    • 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

  6. Metabolic Disturbances

    Time frame: Beginning (week 0) and end of the study (week 12)

    • 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.

  7. Metabolic Disturbances

    Time frame: Beginning (week 0) and end of the study (week 12)

    • 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%

  8. Metabolic Disturbances

    Time frame: Beginning (week 0) and end of the study (week 12)

    • 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

Secondary outcomes

  1. Clinical Measures

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

    Positive and Negative Symptoms

    • Positive and Negative Syndrome Scale (PANSS)

    Description: A widely used clinical scale for assessing the severity of positive and negative symptoms and general psychopathology in schizophrenia and other psychotic disorders.

    Structure: 30 items divided into:

    Positive subscale (7 items)

    Negative subscale (7 items)

    General psychopathology (16 items)

    Scoring: Each item is scored from 1 (absent) to 7 (extreme).

    Ranges:

    Total score: 30-210

    The higher the score, the greater the symptom severity.

    Guideline interpretation (total):

    Mild: ~58-75

    Moderate: ~75-95

    Severe: >95

  2. Clinical Measures

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

    • Brief Negative Symptoms Scale (BNSS)

    Description: Instrument designed specifically to assess negative symptoms in detail.

    Domains assessed (6):

    Anhedonia

    Asociality

    Avolition

    Affective flattening

    Alogia

    Lack of emotional distress

    Structure: 13 items

    Scoring: Items scored from 0 (absent) to 6 (severe).

    Total range: 0-78

    Interpretation:

    Higher scores indicate greater severity of negative symptoms.

  3. Clinical Measures

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

    Cognitive symptoms 3. Screening for Cognitive Impairment in Psychiatry (SCIP)

    Description: Brief test for detecting cognitive impairment in psychiatric patients.

    Domains assessed:

    Verbal learning

    Working memory

    Verbal fluency

    Processing speed

    Delayed memory

    Duration: ~15 minutes

    Scoring: Approximate total scale 0-100 (depending on version).

    Interpretation:

    Lower scores indicate greater cognitive impairment.

    Cut-off points adjusted for age and educational level are used.

  4. Clinical measures

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

    • MATRICS Consensus Cognitive Battery (MCCB)

    Description: Standardized reference battery for assessing cognition in schizophrenia.

    Domains assessed (7):

    Processing speed

    Attention/vigilance

    Working memory

    Verbal learning

    Visual learning

    Reasoning and problem solving

    Social cognition

    Score:

    T scores (mean = 50, SD = 10)

    Interpretation:

    T < 40: below-average performance

    T 40-60: normal range

    T > 60: above-average performance

  5. Clinical Measures

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

    • Cognitive Reserve Assessment Scale in Health (CRASH)

    Description: Scale designed to estimate cognitive reserve, considering premorbid and sociocultural factors.

    Areas assessed:

    Educational level

    Occupation

    Cognitive and leisure activities

    Premorbid intellectual level

    Score: Composite index (no units).

    Interpretation:

    Higher scores indicate greater cognitive reserve, associated with a better functional prognosis.

    Affective symptoms 6. Calgary Depression Scale for Schizophrenia (CDSS)

    Description: Specific scale for assessing depressive symptoms in patients with schizophrenia, differentiating them from negative or extrapyramidal symptoms.

    Structure: 9 items

    Scoring: Items from 0 (absent) to 3 (severe).

    Total range: 0-27

    Interpretation:

    ≥ 6 points suggests the presence of clinically significant depression.

  6. Clinical Measures

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

    Motor symptoms 7. Simpson-Angus Scale (SAS)

    Description: Instrument for assessing extrapyramidal symptoms, especially antipsychotic-induced parkinsonism.

    Structure: 10 items

    Scoring: Items from 0 (normal) to 4 (severe).

    Total score: Average of items or total sum.

    Interpretation:

    Higher scores indicate greater severity of motor symptoms.

  7. Clinical Measures

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

    Overall functioning 8. Global Assessment of Functioning Scale (GAF)

    Description: Global scale that assesses psychological, social, and occupational functioning.

    Range: 0-100

    Interpretation:

    91-100: superior functioning

    71-90: minimal symptoms

    51-70: mild symptoms

    31-50: severe symptoms

    ≤ 30: severe impairment of functioning

  8. Anthropometric Parameters

    Time frame: Along the study: week 0, week 6, and week 12.

    • Weight

    Description: Measurement of the individual's total body mass.

    Units: kilograms (kg)

    Reference ranges:

    There are no universal "normal" ranges, as weight must be interpreted in relation to height, sex, and body composition. It is mainly used to calculate BMI.

  9. Anthropometric Parameters

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

    • Height

    Description: Body length measured in an upright position, from the soles of the feet to the top of the head.

    Units: centimeters (cm) or meters (m)

    Reference ranges:

    Variable depending on sex, age, and ethnicity; used primarily to calculate BMI.

  10. Anthropometric Parameters

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

    • Body Mass Index (BMI)

    Description: Indirect indicator of body fat that relates weight to height.

    Formula:

    BMI = weight (kg)/height (m)2

    Units: kg/m²

    Ranges (WHO):

    Underweight: < 18.5 kg/m²

    Normal weight: 18.5-24.9 kg/m²

    Overweight: 25.0-29.9 kg/m²

    Grade I obesity: 30.0-34.9 kg/m²

    Obesity grade II: 35.0-39.9 kg/m²

    Obesity grade III: ≥ 40 kg/m²

  11. Anthropometric Parameters

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

    • Waist circumference

    Description: Measurement of abdominal circumference, used as an indicator of visceral fat and cardiometabolic risk.

    Units: centimeters (cm)

    Cut-off points (cardiometabolic risk):

    Men: ≥ 102 cm

    Women: ≥ 88 cm (Some European criteria use ≥94 cm in men)

  12. Anthropometric Parameters

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

    • Heart rate

    Description: Number of heartbeats per minute at rest.

    Units: beats per minute (bpm)

    Ranges (resting, adults):

    Normal: 60-100 bpm

    Bradycardia: < 60 bpm

    Tachycardia: > 100 bpm

  13. Anthropometric Parameters

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

    • Blood pressure

    Description: Force exerted by blood against arterial walls, expressed as systolic/diastolic pressure.

    Units: millimeters of mercury (mmHg)

    Ranges (clinical guidelines):

    Normal: < 120 / < 80 mmHg

    Elevated: 120-129 / < 80 mmHg

    Grade 1 hypertension: 130-139 / 80-89 mmHg

    Grade 2 hypertension: ≥ 140 / ≥ 90 mmHg

  14. Anthropometric Parameters

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

    • Skin folds (Skinfold thickness)

    Description: Measurement of subcutaneous adipose tissue thickness using a skinfold caliper; allows estimation of body fat percentage.

    Units: millimeters (mm)

    Common measurement sites:

    Triceps

    Subscapular

    Suprailiac

    Abdominal

    Thigh

    Reference ranges:

    There are no universal values; results are interpreted:

    By summing skinfolds

    By applying predictive equations (e.g., Durnin-Womersley, Jackson-Pollock)

    Interpretation:

    Higher values indicate greater subcutaneous adiposity.

Sponsors and collaborators

Lead sponsor

Manuel Jesús Cuesta Zurita

Other

Collaborators

  • GENBIOMA Aplicaciones SL
  • Universidad Pública de Navarra

Registry information

Official study title

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.

Acronym: GLUCOPSICO

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jan 27, 2026
Registry last updated
Apr 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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