SCHIZOPHRENIA 1 (Disorder)GLUCOPSICONCT07371325
Efficacy of Pediococcus Acidilactici as add-on to Antipsychotic Drugs on Metabolic Syndrome Disturbances in First-episode Psychosis and Schizophrenia Spectrum Disorders.
A study testing Pediococcus acidilactici, pA1c®HI postbiotic supplementation taking participants and Atypical antipsychotics (AAP) in people with SCHIZOPHRENIA 1 (Disorder) and Metabolic Abnormalities, run by Manuel Jesús Cuesta Zurita at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- SCHIZOPHRENIA 1 (Disorder), Metabolic Abnormalities, Postbiotic Supplement
- What is being tested?
- Pediococcus acidilactici, pA1c®HI postbiotic supplementation taking participants and Atypical antipsychotics (AAP)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteSpain
- Study dates
- 8 Sep 2024to 23 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official 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.
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.
Read the 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).
- Being tested
- Pediococcus acidilactici, pA1c®HI postbiotic supplementation taking participants, Atypical antipsychotics (AAP)
- Keywords
- Schizophrenia, First-episode psychosis, Metabolic Syndrome, Postbiotic, Atypical antipsychotics
- Medical subject headings
- Schizophrenia, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pediococcus acidilactici, pA1c®HI postbiotic supplementation taking participantsDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| FEP and postbiotic | Experimental | Participants with FEP diagnostic taking postbiotic and atypical antipsychotics Receives: 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 Receives: 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 Receives: Drug: Atypical antipsychotics (AAP) |
| SSD and placebo | Placebo comparator | Participants with SSD diagnostic taking placebo and atypical antipsychotics Receives: Drug: Atypical antipsychotics (AAP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolic Disturbances
- 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
Measured: Beginning (week 0) and end of the study (week 12).
Metabolic Disturbances
- 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
Measured: Beginning (week 0) and end of the study (week 12)
Metabolic Disturbances
- 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
Measured: Beginning (week 0) and end of the study (week 12)
Metabolic Disturbances
- 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
Measured: Beginning (week 0) and end of the study (week 12)
Metabolic Disturbances
- 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
Measured: Beginning (week 0) and end of the study (week 12)
Metabolic Disturbances
- 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.
Measured: Beginning (week 0) and end of the study (week 12)
Metabolic Disturbances
- 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%
Measured: Beginning (week 0) and end of the study (week 12)
Metabolic Disturbances
- 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
Measured: Beginning (week 0) and end of the study (week 12)
Secondary outcomes (14)
Clinical Measures
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
Measured: Along the study: week 0, week 6, and week 12
Clinical Measures
- 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.
Measured: 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.
Measured: Along the study: week 0, week 6, and week 12
Clinical measures
- 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
Measured: Along the study: week 0, week 6, and week 12
Clinical Measures
- 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.
Measured: 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.
Measured: 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
Measured: Along the study: week 0, week 6, and week 12
Anthropometric Parameters
- 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.
Measured: Along the study: week 0, week 6, and week 12.
Anthropometric Parameters
- 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.
Measured: Along the study: week 0, week 6, and week 12
Anthropometric Parameters
- 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
Measured: Along the study: week 0, week 6, and week 12
Anthropometric Parameters
- 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)
Measured: Along the study: week 0, week 6, and week 12
Anthropometric Parameters
- 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
Measured: Along the study: week 0, week 6, and week 12
Anthropometric Parameters
- 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
Measured: Along the study: week 0, week 6, and week 12
Anthropometric Parameters
- 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.
Measured: Along the study: week 0, week 6, and week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2026
- Study start8 Sep 2024
- Primary completion23 Jan 2026
- Study completion23 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for SCHIZOPHRENIA 1 (Disorder)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manuel Jesús Cuesta Zurita
- Sponsor type
- University, hospital or other
- Collaborators
- Genbioma Aplicaciones SL, Universidad Pública de Navarra
- Responsible party
- Sponsor-investigator, Manuel Jesús Cuesta Zurita, Fundacion Miguel Servet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07371325
- Sponsor's protocol ID
- GLUCOPSICOBIOMICS_2025
- Acronym
- GLUCOPSICO
- Status last verified
- Jan 2026
- First submitted
- 8 Jan 2026
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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
Pillinger T, McCutcheon RA, Vano L, Mizuno Y, Arumuham A, Hindley G, Beck K, Natesan S, Efthimiou O, Cipriani A, Howes OD. 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. Lancet Psychiatry. 2020 Jan;7(1):64-77. doi: 10.1016/S2215-0366(19)30416-X. Epub 2019 Dec 17.
PubMed 31860457Tomasik J, Lago SG, Vazquez-Bourgon J, Papiol S, Suarez-Pinilla P, Crespo-Facorro B, Bahn S. Association of Insulin Resistance With Schizophrenia Polygenic Risk Score and Response to Antipsychotic Treatment. JAMA Psychiatry. 2019 Aug 1;76(8):864-867. doi: 10.1001/jamapsychiatry.2019.0304.
PubMed 30942838Yavorov-Dayliev D, Milagro FI, Ayo J, Oneca M, Aranaz P. Pediococcus acidilactici CECT9879 (pA1c) Counteracts the Effect of a High-Glucose Exposure in C. elegans by Affecting the Insulin Signaling Pathway (IIS). Int J Mol Sci. 2022 Feb 28;23(5):2689. doi: 10.3390/ijms23052689.
PubMed 35269839
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT07371325
- Acronym / sponsor ID
- GLUCOPSICO / GLUCOPSICOBIOMICS_2025
- Keywords
- Schizophrenia, First-episode psychosis, Metabolic Syndrome, Postbiotic, Atypical antipsychotics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Manuel Jesús Cuesta ZuritaUniversity, hospital or other
- Collaborators
- Genbioma Aplicaciones SL, Universidad Pública de Navarra
- Study start
- 8 Sep 2024 (actual)
- Primary completion
- 23 Jan 2026 (actual)
- Study completion
- 23 Jan 2026 (actual)
- First posted
- 27 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| FEP and postbiotic | Experimental | Dietary Supplement: Pediococcus acidilactici, pA1c®HI postbiotic supplementation taking participants, Drug: Atypical antipsychotics (AAP)Participants with FEP diagnostic taking postbiotic and atypical antipsychotics |
| SSD and postbiotic | Experimental | Dietary Supplement: Pediococcus acidilactici, pA1c®HI postbiotic supplementation taking participants, Drug: Atypical antipsychotics (AAP)Participants with SSD diagnostic taking postbiotic and atypical antipsychotics |
| FEP and placebo | Placebo comparator | Drug: Atypical antipsychotics (AAP)Participants with FEP diagnostic taking placebo and atypical antipsychotics |
| SSD and placebo | Placebo comparator | Drug: Atypical antipsychotics (AAP)Participants with SSD diagnostic taking placebo and atypical antipsychotics |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pediococcus acidilactici, pA1c®HI postbiotic supplementation taking participantsThis 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 | Dietary supplement | FEP and postbiotic, SSD and postbiotic |
| Atypical antipsychotics (AAP)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. | Drug | FEP and placebo, FEP and postbiotic, SSD and placebo, SSD and postbiotic |
Primary outcome
Metabolic Disturbances
Time frame: 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
Metabolic Disturbances
Time frame: Beginning (week 0) and end of the study (week 12)
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
Metabolic Disturbances
Time frame: Beginning (week 0) and end of the study (week 12)
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
Metabolic Disturbances
Time frame: Beginning (week 0) and end of the study (week 12)
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
Metabolic Disturbances
Time frame: Beginning (week 0) and end of the study (week 12)
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
Metabolic Disturbances
Time frame: Beginning (week 0) and end of the study (week 12)
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.
Metabolic Disturbances
Time frame: Beginning (week 0) and end of the study (week 12)
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%
Metabolic Disturbances
Time frame: Beginning (week 0) and end of the study (week 12)
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
14 secondary outcomes
Clinical Measures
Time frame: Along the study: week 0, week 6, and week 12
Clinical Measures
Time frame: Along the study: week 0, week 6, and week 12
Clinical Measures
Time frame: Along the study: week 0, week 6, and week 12
Clinical measures
Time frame: Along the study: week 0, week 6, and week 12
Clinical Measures
Time frame: Along the study: week 0, week 6, and week 12
Clinical Measures
Time frame: Along the study: week 0, week 6, and week 12
Clinical Measures
Time frame: Along the study: week 0, week 6, and week 12
Anthropometric Parameters
Time frame: Along the study: week 0, week 6, and week 12.
Anthropometric Parameters
Time frame: Along the study: week 0, week 6, and week 12
Anthropometric Parameters
Time frame: Along the study: week 0, week 6, and week 12
Anthropometric Parameters
Time frame: Along the study: week 0, week 6, and week 12
Anthropometric Parameters
Time frame: Along the study: week 0, week 6, and week 12
Anthropometric Parameters
Time frame: Along the study: week 0, week 6, and week 12
Anthropometric Parameters
Time frame: Along the study: week 0, week 6, and week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- BackgroundKang, 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: PubMed 31860457Pillinger T, McCutcheon RA, Vano L, Mizuno Y, Arumuham A, Hindley G, Beck K, Natesan S, Efthimiou O, Cipriani A, Howes OD. 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. Lancet Psychiatry. 2020 Jan;7(1):64-77. doi: 10.1016/S2215-0366(19)30416-X. Epub 2019 Dec 17.
- Background: PubMed 30942838Tomasik J, Lago SG, Vazquez-Bourgon J, Papiol S, Suarez-Pinilla P, Crespo-Facorro B, Bahn S. Association of Insulin Resistance With Schizophrenia Polygenic Risk Score and Response to Antipsychotic Treatment. JAMA Psychiatry. 2019 Aug 1;76(8):864-867. doi: 10.1001/jamapsychiatry.2019.0304.
- Background: PubMed 35269839Yavorov-Dayliev D, Milagro FI, Ayo J, Oneca M, Aranaz P. Pediococcus acidilactici CECT9879 (pA1c) Counteracts the Effect of a High-Glucose Exposure in C. elegans by Affecting the Insulin Signaling Pathway (IIS). Int J Mol Sci. 2022 Feb 28;23(5):2689. doi: 10.3390/ijms23052689.
- Individual participant dataSharing planned: No
Related trials for SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Not yet recruitingPhase 3
Phase 3 Study of HS-10380 for Acute Schizophrenia in Chinese Adults
SCHIZOPHRENIA 1 (Disorder)
Recruiting
Cognitive Neurocomputational Task Reliability and Clinical Applications Consortium: Study 3
Schizophrenia / Schizoaffective Disorder, SCHIZOPHRENIA 1 (Disorder)
Not yet recruiting
Cognitive Neurocomputational Task Reliability and Clinical Applications Consortium: Study 2
SCHIZOPHRENIA 1 (Disorder), Schizo Affective Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pediococcus acidilactici, pA1c®HI postbiotic supplementation taking participants and Atypical antipsychotics (AAP) in people with SCHIZOPHRENIA 1 (Disorder) and Metabolic Abnormalities, run by Manuel Jesús Cuesta Zurita at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metabolic Disturbances (time frame: Beginning (week 0) and end of the study (week 12).). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07371325, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.