drugset / Trial / NCT07371325
Efficacy of Pediococcus Acidilactici as add-on to Antipsychotic Drugs on Metabolic Syndrome Disturbances in First-episode Psychosis and Schizophrenia Spectrum Disorders.
Completed
36 enrolled
Manuel Jesús Cuesta Zurita
GENBIOMA Aplicaciones SL · collabUniversidad Pública de Navarra · collab
RandomizedParallel-groupTriple-blindSupportive care
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.
Timeline
- Start
- 2024-09-08
- Primary completion
- 2026-01-23
- Completion
- 2026-01-23
Publications
- Background 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
- Background 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.
- Background Tomasik 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 Yavorov-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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pediococcus acidilactici | Other / unclassified | — | — |