Metabolic Abnormalities, Postbiotic Supplement, SCHIZOPHRENIA 1 (Disorder)
Conditions
Keywords
Schizophrenia, First-episode psychosis, Metabolic Syndrome, Postbiotic, Atypical antipsychotics
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.
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).
Interventions
DIETARY_SUPPLEMENTPediococcus 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
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.
Sponsors
Manuel Jesús Cuesta Zurita
GENBIOMA Aplicaciones SL
Universidad Pública de Navarra
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
A double-blind placebo-controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Metabolic Disturbances | Beginning (week 0) and end of the study (week 12). | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Measures | Along the study: week 0, week 6, and week 12 | 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 |
| Clinical measures | Along the study: week 0, week 6, and week 12 | 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 |
| Anthropometric Parameters | Along the study: week 0, week 6, and week 12. | 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. |
Countries
Spain
Outcome results
None listed