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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Enrollment
36
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
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.
Navarrabiomed
Pamplona, Navarre, Spain
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Beginning (week 0) and end of the study (week 12)
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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.
Time frame: 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%
Time frame: 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
Time frame: Beginning (week 0) and end of the study (week 12)
Clinical Measures
Positive and Negative Symptoms 1\. 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
Time frame: Along the study: week 0, week 6, and week 12
Clinical Measures
2\. 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.
Time frame: Along the study: week 0, week 6, and week 12
Clinical Measures
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.
Time frame: Along the study: week 0, week 6, and week 12
Clinical measures
4\. 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
Time frame: Along the study: week 0, week 6, and week 12
Clinical Measures
5\. 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.
Time frame: Along the study: week 0, week 6, and week 12
Clinical Measures
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.
Time frame: Along the study: week 0, week 6, and week 12
Clinical Measures
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
Time frame: Along the study: week 0, week 6, and week 12
Anthropometric Parameters
1\. 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.
Time frame: Along the study: week 0, week 6, and week 12.
Anthropometric Parameters
2\. 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.
Time frame: Along the study: week 0, week 6, and week 12
Anthropometric Parameters
3\. 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
Time frame: Along the study: week 0, week 6, and week 12
Anthropometric Parameters
4\. 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)
Time frame: Along the study: week 0, week 6, and week 12
Anthropometric Parameters
5\. 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
Time frame: Along the study: week 0, week 6, and week 12
Anthropometric Parameters
6\. 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
Time frame: Along the study: week 0, week 6, and week 12
Anthropometric Parameters
7\. 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.
Time frame: Along the study: week 0, week 6, and week 12