NCT07371325Completed
Efficacy of Pediococcus Acidilactici as add-on to Antipsychotic Drugs on Metabolic Syndrome Disturbances in First-episode Psychosis and Schizophrenia Spectrum Disorders.
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.
Source: ClinicalTrials.gov · Last updated 16 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 36 (actual)
- First submitted
- 8 Jan 2026
- Start date
- 8 Sept 2024
- Primary completion date
- 23 Jan 2026
- Lead sponsor
- Manuel Jesús Cuesta Zurita
- Diseases
- Schizophrenia
- NCT number
- NCT07371325
What you commit to
- Study type: Interventional
- Participants enrolled: 36
- From 8 Sept 2024 to the primary completion date, 23 Jan 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Antibiotic medication in the previous 14 days
Other illness
- Clinically significant medical condition (congestive heart failure, liver disease, renal failure, acute pancreatitis, cancer undergoing active treatment, HIV, or other immunodeficiency)
- Celiac disease
Other
- Inability to give informed consent, lack of a representative or legal guardian capable of giving consent
- Intellectual disability
- Active substance use in the last 3 months (except nicotine)
- Pregnancy or breastfeeding
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Navarrabiomed Coordinator of this site? Confirm its status | Pamplona | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.