Clinical translation of microbe‐based therapies: Current clinical landscape and preclinical outlook
Open accessAbstract
Next generation microbe‐based therapeutics, inspired by the success of fecal microbiota transplants, are being actively investigated in clinical trials to displace or eliminate pathogenic microbes to treat various diseases in the gastrointestinal tract, skin, and vagina. Genetically engineered microbes are also being investigated in the clinic as drug producing factories for biologic delivery, which can provide a constant local source of drugs. In either case, microbe‐therapeutics have the opportunity to address unmet clinical needs and open new areas of research by reducing clinical side effects associated with current treatment modalities or by facilitating the delivery of biologics. This review will discuss examples of past and current clinical trials that are investigating microbe‐therapeutics, both microbiome‐modulating and drug‐producing, for the treatment of a range of diseases. We then offer a perspective on how preclinical approaches, both those focused on developing advanced delivery systems and those that use in vitro microbiome model systems to inform formulation design, will lead to the realization of next‐generation microbe‐therapeutics.
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Microorganisms can interact with the microbiome to control metabolic processes, chronic inflammatory processes, and mucosal immunity.
“For instance, reprogrammed immune cells can use the immune system to treat cancer and administer vaccinations, while microorganisms can interact with the microbiome to control metabolic processes, chronic inflammatory processes, and mucosal immunity.320–322”
From Smart nanoparticles for cancer therapy (2023) · cites this paper as [320]
Reprogrammed immune cells can use the immune system to treat cancer and administer vaccinations.
“For instance, reprogrammed immune cells can use the immune system to treat cancer and administer vaccinations, while microorganisms can interact with the microbiome to control metabolic processes, chronic inflammatory processes, and mucosal immunity.320–322”
From Smart nanoparticles for cancer therapy (2023) · cites this paper as [320]
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The evolution of commercial drug delivery technologies
Vargason, A. M., Anselmo, A. C., & Mitragotri, S. (2021) · Nature Biomedical Engineering · doi:10.1038/s41551-021-00698-w · Cited by 1,361 · see citing works
Self-citationSmart nanoparticles for cancer therapy
Sun, L., Liu, H., Ye, Y., Lei, Y., Islam, R., Tan, S., Tong, R., Miao, Y.-B., & Cai, L. (2023) · Signal Transduction and Targeted Therapy · doi:10.1038/s41392-023-01642-x · Cited by 1,073 · see citing works
Engineered living biomaterials
Rodrigo-Navarro, A., Sankaran, S., Dalby, M., del Campo, A., & Salmerón-Sánchez, M. (2021) · Nature Reviews Materials · doi:10.1038/s41578-021-00350-8 · Cited by 419 · see citing works
Circadian rhythms and the gut microbiota: from the metabolic syndrome to cancer
Bishehsari, F., Voigt, R. M., & Keshavarzian, A. (2020) · Nature Reviews Endocrinology · doi:10.1038/s41574-020-00427-4 · Cited by 378 · see citing works
Nanotechnology intervention of the microbiome for cancer therapy
Song, W., Anselmo, A. C., & Huang, L. (2019) · Nature Nanotechnology · doi:10.1038/s41565-019-0589-5 · Cited by 247 · see citing works
Self-citationLi, Z., Wang, Y., Liu, J., Rawding, P. A., Bu, J., Hong, S., & Hu, Q. (2021) · Advanced Materials · doi:10.1002/adma.202102580 · Cited by 243 · see citing works
Design of synthetic human gut microbiome assembly and butyrate production
Clark, R. L., Connors, B., Stevenson, D. M., Hromada, S. E., Hamilton, J. J., Amador‐Noguez, D., & Venturelli, O. S. (2021) · Nature Communications · doi:10.1038/s41467-021-22938-y · Cited by 197 · see citing works
Zhu, L., Yu, T., Wang, W., Xu, T., Geng, W., Li, N., & Zan, X. (2024) · Advanced Materials · doi:10.1002/adma.202308728 · Cited by 166 · see citing works
Wang, L. L., Janes, M. E., Kumbhojkar, N., Kapate, N., Clegg, J. R., Prakash, S., Heavey, M. K., Zhao, Z., Anselmo, A. C., & Mitragotri, S. (2021) · Bioengineering & Translational Medicine · doi:10.1002/btm2.10214 · Cited by 162 · see citing works
Self-citationKumar, R., Sood, U., Gupta, V., Singh, M., Scaria, J., & Lal, R. (2019) · Indian Journal of Microbiology · doi:10.1007/s12088-019-00808-y · Cited by 133 · see citing works
Chang, S.-C., Shen, M., Liu, C., Pu, C., Hu, J., & Huang, C. (2020) · Oncology Letters · doi:10.3892/ol.2020.12190 · Cited by 105 · see citing works
Surface Modifications for Improved Delivery and Function of Therapeutic Bacteria
Vargason, A. M., Santhosh, S., & Anselmo, A. C. (2020) · Small · doi:10.1002/smll.202001705 · Cited by 85 · see citing works
Self-citationSmith, R. S. H., Bader, C., Sharma, S., Kolb, D., Tang, T., Hosny, A., Moser, F., Weaver, J. C., Voigt, C. A., & Oxman, N. (2019) · Advanced Functional Materials · doi:10.1002/adfm.201907401 · Cited by 74 · see citing works
Zhi, X., Liu, Y., Lin, L., Yang, M., Zhang, L., Zhang, L., Liu, Y., Alfranca, G., Ma, L., Zhang, Q., et al. (2019) · Nanomedicine Nanotechnology Biology and Medicine · doi:10.1016/j.nano.2019.102019 · Cited by 64 · see citing works
Biosensing in Smart Engineered Probiotics
Rottinghaus, A. G., Amrofell, M. B., & Moon, T. S. (2019) · Biotechnology Journal · doi:10.1002/biot.201900319 · Cited by 63 · see citing works
Wang, S., Ju, D., & Zeng, X. L. (2024) · Biomedicines · doi:10.3390/biomedicines12010194 · Cited by 60 · see citing works
Inorganic nanoparticles and the microbiome
Qiu, K., Durham, P. G., & Anselmo, A. C. (2018) · Nano Research · doi:10.1007/s12274-018-2137-2 · Cited by 54 · see citing works
Self-citationFu, Y., Li, J., Cai, W., Huang, Y., Liu, X., Ma, Z., Tang, Z., Bian, X., Zheng, J., Jiang, J., et al. (2024) · Acta Pharmaceutica Sinica B · doi:10.1016/j.apsb.2023.11.018 · Cited by 48 · see citing works
Extrinsic Factors Shaping the Skin Microbiome
Moskovicz, V., Gross, A., & Mizrahi, B. (2020) · Microorganisms · doi:10.3390/microorganisms8071023 · Cited by 47 · see citing works
Gut microbiota targeted nanomedicine for cancer therapy: Challenges and future considerations
Rajoka, M. S. R., Mehwish, H. M., Xiong, Y., Song, X., Hussain, N., Zhu, Q., & He, Z. (2020) · Trends in Food Science & Technology · doi:10.1016/j.tifs.2020.10.036 · Cited by 46 · see citing works
Challenges & opportunities for phage-based in situ microbiome engineering in the gut
Voorhees, P. J., Cruz-Teran, C. A., Edelstein, J., & Lai, S. K. (2020) · Journal of Controlled Release · doi:10.1016/j.jconrel.2020.06.016 · Cited by 43 · see citing works
Weaponising microbes for peace
Anand, S., Hallsworth, J. E., Timmis, J. K., Verstraete, W., Casadevall, A., Ramos, J. L., Sood, U., Kumar, R., Hira, P., Rawat, C. D., et al. (2023) · Microbial Biotechnology · doi:10.1111/1751-7915.14224 · Cited by 41 · see citing works
Macroencapsulated bacteria for in vivo sensing and therapeutics
Lyu, Y., Huang, H., Su, Y., Ying, B., Liu, W.-C., Dong, K., Du, N., Langer, R., Gu, Z., & Nan, K. (2024) · Matter · doi:10.1016/j.matt.2024.01.031 · Cited by 38 · see citing works
Micro and nanotechnologies: The little formulations that could
Stiepel, R. T., Duggan, E., Batty, C. J., & Ainslie, K. M. (2022) · Bioengineering & Translational Medicine · doi:10.1002/btm2.10421 · Cited by 35 · see citing works
Translational strategies for oral delivery of faecal microbiota transplantation
Kamath, S., Bryant, R. V., Costello, S. P., Day, A. S., Forbes, B., Haifer, C., Hold, G. L., Kelly, C. R., Li, A., Pakuwal, E., et al. (2025) · Gut · doi:10.1136/gutjnl-2025-335077 · Cited by 34 · see citing works
Live Biotherapeutic Products and Probiotics for the Skin
Vargason, A. M., & Anselmo, A. C. (2021) · Advanced NanoBiomed Research · doi:10.1002/anbr.202100118 · Cited by 29 · see citing works
Self-citationVieira-Baptista, P., Seta, F. D., Verstraelen, H., Ventolini, G., Lonnee-Hoffmann, R., & Lev-Sagie, A. (2021) · Journal of Lower Genital Tract Disease · doi:10.1097/lgt.0000000000000647 · Cited by 29 · see citing works
Pérez, M., Ntemiri, A., Tan, H., Harris, H. M. B., Roager, H. M., Ribière, C., & O’Toole, P. W. (2021) · Gut Microbes · doi:10.1080/19490976.2021.1919464 · Cited by 28 · see citing works
Polymeric Films for the Encapsulation, Storage, and Tunable Release of Therapeutic Microbes
Qiu, K., Young, I. C., Woodburn, B. M. D., Huang, Y., & Anselmo, A. C. (2020) · Advanced Healthcare Materials · doi:10.1002/adhm.201901643 · Cited by 23 · see citing works
Self-citationMicrobes Saving Lives and Reducing Suffering
Timmis, K. N., Karahan, Z. C., Ramos, J. L., Koren, O., Pérez‐Cobas, A. E., Steward, K. F., de Lorenzo, V., Caselli, E., Douglas, M., Schwab, C., et al. (2025) · Microbial Biotechnology · doi:10.1111/1751-7915.70068 · Cited by 23 · see citing works
In vitro assembly of plasmid DNA for direct cloning in Lactiplantibacillus plantarum WCSF1
Blanch‐Asensio, M., Dey, S., & Sankaran, S. (2023) · PLoS ONE · doi:10.1371/journal.pone.0281625 · Cited by 16 · see citing works
Bacterial Systems as a Precision Delivery Platform of Therapeutic Peptides for Cancer Therapy
Liu, J., Shen, G., & Yan, X. (2025) · Polymer science & technology. · doi:10.1021/polymscitech.4c00026 · Cited by 14 · see citing works
Evaluation of Surface Modified Live Biotherapeutic Products for Oral Delivery
Vargason, A. M., & Anselmo, A. C. (2020) · ACS Biomaterials Science & Engineering · doi:10.1021/acsbiomaterials.0c01405 · Cited by 12 · see citing works
Self-citationVieira‐Baptista, P., Seta, F. D., Verstraelen, H., Ventolini, G., Lonnée-Hoffmann, R. A. M., & Lev‐Sagie, A. (2022) · NORA - Norwegian Open Research Archives · Cited by 12 · see citing works
Engineered microorganism-based delivery systems for targeted cancer therapy: a narrative review.
Huang, X., Guo, H., Wang, L., & Shao, Z. (2022) · PubMed Central · doi:10.12336/biomatertransl.2022.03.004 · Cited by 11 · see citing works
Bioinspired and biomimetic strategies for inflammatory bowel disease therapy
Zhang, L., Ye, P., Zhu, H., Zhu, L., Ren, Y., & Lei, J. (2024) · Journal of Materials Chemistry B · doi:10.1039/d3tb02995f · Cited by 10 · see citing works
Enhanced Storage of Anaerobic Bacteria through Polymeric Encapsulation
Qiu, K., & Anselmo, A. C. (2021) · ACS Applied Materials & Interfaces · doi:10.1021/acsami.1c11785 · Cited by 10 · see citing works
Self-citationPolymer and Crosslinker Content Influences Performance of Encapsulated Live Biotherapeutic Products
Qiu, K., Huang, Y., & Anselmo, A. C. (2021) · Cellular and Molecular Bioengineering · doi:10.1007/s12195-021-00674-z · Cited by 10 · see citing works
Self-citationModulating Oral Delivery and Gastrointestinal Kinetics of Recombinant Proteins via Engineered Fungi
Heavey, M. K., & Anselmo, A. C. (2021) · The AAPS Journal · doi:10.1208/s12248-021-00606-9 · Cited by 9 · see citing works
Self-citationPeptides in chronic wound healing: Fighting infections and facilitating diabetic wound management
Aquib, M., Sharma, T., Giri, V. P., & Rao, A. V. (2025) · Journal of Drug Delivery Science and Technology · doi:10.1016/j.jddst.2025.106599 · Cited by 8 · see citing works
Overcoming barriers to delivery of biologics by novel approaches and advanced delivery systems
Ahator, S. D., Franzè, S., Obuobi, S. A. O., Anderluzzi, G., Flaten, G. E., & Škalko‐Basnet, N. (2026) · Advanced Drug Delivery Reviews · doi:10.1016/j.addr.2026.115875 · Cited by 8 · see citing works
Engineered Tissue Models to Decode Host–Microbiota Interactions
Adelfio, M., Callen, G. E., He, X., Paster, B. J., Hastürk, H., & Ghezzi, C. E. (2025) · Advanced Science · doi:10.1002/advs.202417687 · Cited by 6 · see citing works
Li, R., Xiao, Y., Zhaoxin, L., Meng, F., & Bie, X. (2025) · Chemical Engineering Journal · doi:10.1016/j.cej.2025.163484 · Cited by 5 · see citing works
Venugopal, A., Sionov, R. V., Kroupitski, Y., Steinberg, D., & Shemesh, M. (2024) · Food Frontiers · doi:10.1002/fft2.514 · Cited by 5 · see citing works
Montgomery, V. A., Wood‐Yang, A. J., Styczynski, M. P., & Prausnitz, M. R. (2024) · Bioengineering & Translational Medicine · doi:10.1002/btm2.10645 · Cited by 5 · see citing works
Gulati, M., Singh, S. K., Corrie, L., Chandwani, L., Singh, A., Kapoor, B., Kumar, R., Pandey, N. K., Kumar, B., Awasthi, A., et al. (2020) · Recent Advances in Anti-Infective Drug Discovery · doi:10.2174/1574891x15666200925092354 · Cited by 4 · see citing works
The Nature and Functions of Vertebrate Skin Microbiota
Hoffmann, A. R., Older, C. E., & Faccin, M. (2022) · Progress in inflammation research · doi:10.1007/978-3-030-91051-8_9 · Cited by 4 · see citing works
Batch Culture Formulation of Live Biotherapeutic Products
Qiu, K., & Anselmo, A. C. (2020) · Advanced Therapeutics · doi:10.1002/adtp.202000226 · Cited by 4 · see citing works
Self-citationAdvancing the in vitro drug screening models: Microbiome as a component of tissue-engineered skin
Shishkov, V. V., Bikmulina, P., Kardosh, A. V., Tsibulnikov, S. V., Grekova, E. V., Колесова, Y. V., Zakharova, P. A., Nesterova, A. M., Pereira, F. D. A. S., Kotova, S., et al. (2024) · Bioprinting · doi:10.1016/j.bprint.2024.e00379 · Cited by 3 · see citing works
Engineered microbial sensors: providing a new paradigm for disease detection
Shi, X.-R., Zhang, Y., Zhou, Y. Q., Zou, Z., & Ye, B. (2025) · Journal of Materials Chemistry B · doi:10.1039/d5tb01468a · Cited by 2 · see citing works
Moving Microbiome Science from the Bench to the Bedside: a Physician-Scientist Perspective
Surana, N. K. (2019) · mSystems · doi:10.1128/msystems.00160-19 · Cited by 2 · see citing works
SCFAs in T1D: A microbiota-targeted approach for immune tolerance
Mariño, E. (2022) · Current Opinion in Endocrine and Metabolic Research · doi:10.1016/j.coemr.2022.100355 · Cited by 2 · see citing works
Patents, bioproducts, commercialization, social, ethical, and economic policies on microbiome
Michael, O. S., Adetunji, J. B., Akinwale, E. O., Oluranti, O. I., Ajayi, O. O., Adetunji, C. O., Soladoye, A. O., & Oyewole, O. A. (2024) · Elsevier eBooks · doi:10.1016/b978-0-323-91190-0.00008-4 · Cited by 2 · see citing works
Microbes for a Sustainable World: Pioneering the SDGs Through Microbial Ingenuity
Das, N., Das, A., Mazumder, D., Bhuyan, B., Debnath, S., Chowdhury, R., Thaosen, R., & Pandey, P. (2025) · Microorganisms for sustainability · doi:10.1007/978-981-96-9025-1_1 · Cited by 1 · see citing works
Ye, Y., Shen, J., & Zhilong, X. (2025) · Synthetic biology and engineering · doi:10.70322/sbe.2025.10020 · Cited by 1 · see citing works
Coordinated microbial lysis bursts into the drug delivery scene
Sen, S., & Kunjapur, A. M. (2023) · Trends in biotechnology · doi:10.1016/j.tibtech.2023.01.010 · Cited by 1 · see citing works
Momunova, A., Rahim, F., Alekesheva, L., Karlygash, T., Konstantinovich, S. D., Dzhusupov, K. O., & Zhumagaliuly, A. (2024) · Egyptian Journal of Veterinary Science · doi:10.21608/ejvs.2024.262801.1781 · Cited by 1 · see citing works
Clinical Translation of Microbe-Based Therapies
Murthy, S., Balagurunathan, R., Anbalmani, S., & Nagarajan, S. (2024) · Springer eBooks · doi:10.1007/978-981-97-1777-4_11 · Cited by 1 · see citing works
Deshpande, K., Tadimarri, V. S., Ramirez-Rangel, J., Sankaran, S., & Trujillo, S. (2025) · ACS Pharmacology & Translational Science · doi:10.1021/acsptsci.5c00216 · Cited by 1 · see citing works
Microbiota Based Management of the Gastrointestinal Disorders
Mouli, V. P., & Ahuja, V. (2020) · Elsevier eBooks · doi:10.1016/b978-0-12-819265-8.00011-5
Gibson Assembly-based direct cloning of plasmid DNA in Lactiplantibacillus plantarum WCSF1Preprint
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Effect of Anticancer Treatment Approaches on Gut Microbiota
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Microbiome and Reproductive Health
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Microbial therapeutic agents as a new frontier in tumor-targeted drug delivery
Islam, T., Ali, S., Almalki, M., & Rabbee, M. F. (2026) · Journal of Drug Delivery Science and Technology · doi:10.1016/j.jddst.2026.108366
AI in Drug Discovery and Personalized Medicine Based on Pharmacomicrobiomics
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Oncolytic Virus-like Nanoparticle Targets the Golgi Apparatus via Sphingomyelin
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- Authors
- Vargason, A. M., & Anselmo, A. C.
- Affiliations
- University of North Carolina at Chapel Hill (US)
- Corresponding author
- Vargason, Ava M.
- Venue
- Bioengineering & Translational Medicine
- Publisher
- Wiley
- Published
- 2018-05
- Volume
- 3
- Issue
- 2
- Pages
- 124-137
- ISSN
- 2380-6761 (ISSN-L)
- PMC
- PMC6063871
- OpenAlex
- W2802147580
- Cited by
- 71
- References
- 88
- Citations by year
- 2026: 7 · 2025: 12 · 2024: 11 · 2023: 6 · 2022: 6 · 2021: 11 · 2020: 11 · 2019: 6 · 2018: 1
- FWCI
- 0.71
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- Bioengineering & Translational Medicine (publishedVersion, cc-by)
- Europe PMC (PubMed Central) (publishedVersion, other-oa)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Topics
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Gut microbiota and health
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Biotechnology › Cancer Research and Treatments
- Life Sciences › Agricultural and Biological Sciences › Food Science › Probiotics and Fermented Foods
- Keywords
- fecal microbiota transplantation, genetically modified microorganisms, microbiota modulation, biologic delivery, clinical trials, preclinical drug development, delivery systems, gastrointestinal diseases
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