Fecal microbiota transplantation (FMT) and live biotherapeutic products (LBPs): from standard treatment of Clostridioides difficile to emerging perspectives in neuropsychiatry
DOI:
https://doi.org/10.12775/JEHS.2026.87.68108Keywords
fecal microbiota transplantation, gut microbiota, donor screening, Clostridioides difficile infection, live biotherapeutic productsAbstract
Background: Fecal Microbiota Transplantation (FMT) has evolved from an experimental procedure into a recognized standard in the treatment of intestinal dysbiosis. Although this method is widely associated with the therapy of C. difficile infections, a growing understanding of the microbiota-gut-brain axis suggests its potential in the treatment of neurodevelopmental and psychiatric disorders.
Aim: The aim of this review is to discuss the efficacy of FMT in the standard treatment of C. difficile infections, as well as to evaluate its potential in managing neurodevelopmental disorders (ASD, ADHD) and depression.
Material and methods: The analysis was based on a review of English-language literature from the years 2019–2025, along with selected historical references. The query was conducted in the PubMed, Google Scholar, and Web of Science databases using terms related to fecal microbiota transplantation, gut microbiota, donor screening, C. difficile infections and live biotherapeutic products.
Results: Treatment efficacy is the result of the interaction between donor and recipient characteristics. In cases of recurrent C. difficile, FMT remains an important therapeutic alternative, currently complemented by standardized live biotherapeutic products (LBPs) such as Rebyota and Vowst, which eliminate the issue of sample variability. In psychiatry, distinct mechanisms of action are observed. In patients with ASD and ADHD, neurotransmitter modulation and inflammation reduction occur, whereas in depression, the efficacy of microbiotic interventions strictly depends on the integrity of the vagus nerve.
Conclusions: The evolution of FMT toward ready-to-use pharmaceutical products confirms its efficacy in C. difficile infections, and growing evidence suggests its applicability in neuropsychiatric disorders. The future of the method depends on optimizing the donor-recipient-procedure triad and implementing precise bacterial consortia to minimize the risk of failure.
References
1. Wang, X., Zhao, D., Bi, D., Li, L., Tian, H., Yin, F., Zuo, T., Ianiro, G., Li, N., Chen, Q., & Qin, H. (2025). Fecal microbiota transplantation: transitioning from chaos and controversial realm to scientific precision era. Science bulletin, 70(6), 970–985. https://doi.org/10.1016/j.scib.2025.01.029
2. Hoffmann, D. E., Javitt, G. H., Kelly, C. R., Keller, J. J., Baunwall, S. M. D., & Hvas, C. L. (2025). Fecal microbiota transplantation: a tale of two regulatory pathways. Gut microbes, 17(1), 2493901. https://doi.org/10.1080/19490976.2025.2493901
3. Zhang, F., Luo, W., Shi, Y., Fan, Z., & Ji, G. (2012). Should we standardize the 1,700-year-old fecal microbiota transplantation?. The American journal of gastroenterology, 107(11), 1755–p.1756. https://doi.org/10.1038/ajg.2012.251
4. Eiseman, B., Silen, W., Bascom, G. S., & Kauvar, A. J. (1958). Fecal enema as an adjunct in the treatment of pseudomembranous enterocolitis. Surgery, 44(5), 854–859.
5. Bakken, J. S., Borody, T., Brandt, L. J., Brill, J. V., Demarco, D. C., Franzos, M. A., Kelly, C., Khoruts, A., Louie, T., Martinelli, L. P., Moore, T. A., Russell, G., Surawicz, C., & Fecal Microbiota Transplantation Workgroup (2011). Treating Clostridium difficile infection with fecal microbiota transplantation. Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association, 9(12), 1044–1049. https://doi.org/10.1016/j.cgh.2011.08.014
6. Brandt, L. J., Aroniadis, O. C., Mellow, M., Kanatzar, A., Kelly, C., Park, T., Stollman, N., Rohlke, F., & Surawicz, C. (2012). Long-term follow-up of colonoscopic fecal microbiota transplant for recurrent Clostridium difficile infection. The American journal of gastroenterology, 107(7), 1079–1087. https://doi.org/10.1038/ajg.2012.60
7. Porcari, S., Benech, N., Valles-Colomer, M., Segata, N., Gasbarrini, A., Cammarota, G., Sokol, H., & Ianiro, G. (2023). Key determinants of success in fecal microbiota transplantation: From microbiome to clinic. Cell host & microbe, 31(5), 712–733. https://doi.org/10.1016/j.chom.2023.03.020
8. Cymbal, M., Chatterjee, A., Baggott, B., & Auron, M. (2024). Management of Clostridioides difficile Infection: Diagnosis, Treatment, and Future Perspectives. The American journal of medicine, 137(7), 571–576. https://doi.org/10.1016/j.amjmed.2024.03.024
9. Czepiel, J., Dróżdż, M., Pituch, H., Kuijper, E. J., Perucki, W., Mielimonka, A., Goldman, S., Wultańska, D., Garlicki, A., & Biesiada, G. (2019). Clostridium difficile infection: review. European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology, 38(7), 1211–1221. https://doi.org/10.1007/s10096-019-03539-6
10. Guery, B., Galperine, T., & Barbut, F. (2019). Clostridioides difficile: diagnosis and treatments. BMJ (Clinical research ed.), 366, l4609. https://doi.org/10.1136/bmj.l4609
11. Johnson, S., Lavergne, V., Skinner, A. M., Gonzales-Luna, A. J., Garey, K. W., Kelly, C. P., & Wilcox, M. H. (2021). Clinical Practice Guideline by the Infectious Diseases Society of America (IDSA) and Society for Healthcare Epidemiology of America (SHEA): 2021 Focused Update Guidelines on Management of Clostridioides difficile Infection in Adults. Clinical infectious diseases: an official publication of the Infectious Diseases Society of America, 73(5), e1029–e1044. https://doi.org/10.1093/cid/ciab549
12. Kelly, C. R., Fischer, M., Allegretti, J. R., LaPlante, K., Stewart, D. B., Limketkai, B. N., & Stollman, N. H. (2021). ACG Clinical Guidelines: Prevention, Diagnosis, and Treatment of Clostridioides difficile Infections. The American journal of gastroenterology, 116(6), 1124–1147. https://doi.org/10.14309/ajg.0000000000001278
13. Fischer, M., Sipe, B., Cheng, Y. W., Phelps, E., Rogers, N., Sagi, S., Bohm, M., Xu, H., & Kassam, Z. (2017). Fecal microbiota transplant in severe and severe-complicated Clostridium difficile: A promising treatment approach. Gut microbes, 8(3), 289–302. https://doi.org/10.1080/19490976.2016.1273998
14. Khanna, S., Assi, M., Lee, C., Yoho, D., Louie, T., Knapple, W., Aguilar, H., Garcia-Diaz, J., Wang, G. P., Berry, S. M., Marion, J., Su, X., Braun, T., Bancke, L., & Feuerstadt, P. (2022). Efficacy and Safety of RBX2660 in PUNCH CD3, a Phase III, Randomized, Double-Blind, Placebo-Controlled Trial with a Bayesian Primary Analysis for the Prevention of Recurrent Clostridioides difficile Infection. Drugs, 82(15), 1527–1538. https://doi.org/10.1007/s40265-022-01797-x
15. Khanna, S., Sims, M., Louie, T. J., Fischer, M., LaPlante, K., Allegretti, J., Hasson, B. R., Fonte, A. T., McChalicher, C., Ege, D. S., Bryant, J. A., Straub, T. J., Ford, C. B., Henn, M. R., Wang, E. E. L., von Moltke, L., & Wilcox, M. H. (2022). SER-109: An Oral Investigational Microbiome Therapeutic for Patients with Recurrent Clostridioides difficile Infection (rCDI). Antibiotics (Basel, Switzerland), 11(9), 1234. https://doi.org/10.3390/antibiotics11091234
16. Zhuang, L., Chen, H., Zhang, S., Zhuang, J., Li, Q., & Feng, Z. (2019). Intestinal Microbiota in Early Life and Its Implications on Childhood Health. Genomics, proteomics & bioinformatics, 17(1), 13–25. https://doi.org/10.1016/j.gpb.2018.10.002
17. Li, N., Chen, H., Cheng, Y., Xu, F., Ruan, G., Ying, S., Tang, W., Chen, L., Chen, M., Lv, L., Ping, Y., Chen, D., & Wei, Y. (2021). Fecal Microbiota Transplantation Relieves Gastrointestinal and Autism Symptoms by Improving the Gut Microbiota in an Open-Label Study. Frontiers in cellular and infection microbiology, 11, 759435. https://doi.org/10.3389/fcimb.2021.759435
18. Chen, K., Fu, Y., Wang, Y., Liao, L., Xu, H., Zhang, A., Zhang, J., Fan, L., Ren, J., & Fang, B. (2020). Therapeutic Effects of the In Vitro Cultured Human Gut Microbiota as Transplants on Altering Gut Microbiota and Improving Symptoms Associated with Autism Spectrum Disorder. Microbial ecology, 80(2), 475–486. https://doi.org/10.1007/s00248-020-01494-w
19. Hooi, S. L., Dwiyanto, J., Rasiti, H., Toh, K. Y., Wong, R. K. M., & Lee, J. W. J. (2022). A case report of improvement on ADHD symptoms after fecal microbiota transplantation with gut microbiome profiling pre- and post-procedure. Current medical research and opinion, 38(11), 1977–1982. https://doi.org/10.1080/03007995.2022.2129232
20. Basen, M., & Kurrer, S. E. (2021). A close look at pentose metabolism of gut bacteria. The FEBS journal, 288(6), 1804–1808. https://doi.org/10.1111/febs.15575
21. Zhang, Q., Bi, Y., Zhang, B., Jiang, Q., Mou, C. K., Lei, L., Deng, Y., Li, Y., Yu, J., Liu, W., & Zhao, J. (2024). Current landscape of fecal microbiota transplantation in treating depression. Frontiers in immunology, 15, 1416961. https://doi.org/10.3389/fimmu.2024.1416961
22. Loh, J. S., Mak, W. Q., Tan, L. K. S., Ng, C. X., Chan, H. H., Yeow, S. H., Foo, J. B., Ong, Y. S., How, C. W., & Khaw, K. Y. (2024). Microbiota-gut-brain axis and its therapeutic applications in neurodegenerative diseases. Signal transduction and targeted therapy, 9(1), 37. https://doi.org/10.1038/s41392-024-01743-1
23. Wang, S., Ishima, T., Qu, Y., Shan, J., Chang, L., Wei, Y., Zhang, J., Pu, Y., Fujita, Y., Tan, Y., Wang, X., Ma, L., Wan, X., Hammock, B. D., & Hashimoto, K. (2021). Ingestion of Faecalibaculum rodentium causes depression-like phenotypes in resilient Ephx2 knock-out mice: A role of brain-gut-microbiota axis via the subdiaphragmatic vagus nerve. Journal of affective disorders, 292, 565–573. https://doi.org/10.1016/j.jad.2021.06.006
24. Pu, Y., Tan, Y., Qu, Y., Chang, L., Wang, S., Wei, Y., Wang, X., & Hashimoto, K. (2021). A role of the subdiaphragmatic vagus nerve in depression-like phenotypes in mice after fecal microbiota transplantation from Chrna7 knock-out mice with depression-like phenotypes. Brain, behavior, and immunity, 94, 318–326. https://doi.org/10.1016/j.bbi.2020.12.032
25. Wang, Y., Hunt, A., Danziger, L., & Drwiega, E. N. (2024). A Comparison of Currently Available and Investigational Fecal Microbiota Transplant Products for Recurrent Clostridioides difficile Infection. Antibiotics (Basel, Switzerland), 13(5), 436. https://doi.org/10.3390/antibiotics13050436
Downloads
Published
How to Cite
Issue
Section
License
Copyright (c) 2026 Piotr Czwałga, Michał Magiera, Patrycja Koprowska, Miłosz Sikora

This work is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License.
The periodical offers access to content in the Open Access system under the Creative Commons Attribution-NonCommercial-ShareAlike 4.0
Stats
Number of views and downloads: 45
Number of citations: 0