Future indications and clinical management for fecal microbiota transplantation (FMT) in immuno-oncology
Abstract
The gut microbiota has rapidly emerged as one of the "hallmarks of cancers" and a key contributor to cancer immunotherapy. Metagenomics profiling has established the link between microbiota compositions and immune checkpoint inhibitors response and toxicity, while murine experiments demonstrating the synergistic benefits of microbiota modification with immune checkpoint inhibitors (ICIs) pave a clear path for translation. Fecal microbiota transplantation (FMT) is one of the most effective treatments for patients with Clostridioides difficile, but its utility in other disease contexts has been limited. Nonetheless, promising data from the first trials combining FMT with ICIs have provided strong clinical rationale to pursue this strategy as a novel therapeutic avenue. In addition to the safety considerations surrounding new and emerging pathogens potentially transmissible by FMT, several other challenges must be overcome in order to validate the use of FMT as a therapeutic option in oncology. In this review, we will explore how the lessons learned from FMT in other specialties will help shape the design and development of FMT in the immuno-oncology arena.
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Quality control and donor screening carry the risk of transmitting multi-drug-resistant organisms or other pathogens.
“A related challenge concerns quality control and donor screening, with the risk of transmitting multi-drug–resistant organisms or other pathogens (Jamal et al., 2023; Zipkin, 2021).”
From Microbiota-centered interventions to boost immune checkpoint blockade therapies (2025) · cites this paper as Jamal et al., 2023
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Self-citationDamman, C. J., Brittnacher, M., Westerhoff, M. A., Hayden, H. S., Radey, M. C., Hager, K. R., Marquis, S. R., Miller, S. I., & Zisman, T. L. (2015) · PLoS ONE · doi:10.1371/journal.pone.0133925 · Cited by 73 · see citing works
Bar‐Yoseph, H., Carasso, S., Shklar, S., Korytny, A., Dar, R. E., Daoud, H., Nassar, R., Maharshak, N., Hussein, K., Geffen, Y., et al. (2020) · Clinical Infectious Diseases · doi:10.1093/cid/ciaa737 · Cited by 70 · see citing works
Martínez-Gili, L., McDonald, J. A. K., Liu, Z., Kao, D. H., Allegretti, J. R., Monaghan, T. M., Barker, G. F., Blanco, J. M., Williams, H. R. T., Holmes, E. C., et al. (2020) · Gut Microbes · doi:10.1080/19490976.2020.1810531 · Cited by 62 · see citing works
Rutkowski, P. L., Indini, A., Luca, M. D., Merelli, B., Mariuk-Jarema, A., Teterycz, P., Rogala, P., Lugowska, I. A., Cybulska-Stopa, B., Labianca, A., et al. (2020) · Journal for ImmunoTherapy of Cancer · doi:10.1136/jitc-2020-001117 · Cited by 62 · see citing works
Goll, R., Johnsen, P. H., Hjerde, E., Diab, J., Valle, P. C., Hilpüsch, F., & Cavanagh, J. P. (2020) · Gut Microbes · doi:10.1080/19490976.2020.1794263 · Cited by 60 · see citing works
Craven, L. J., Parvathy, S. N., Tat-Ko, J., Burton, J. P., & Silverman, M. (2017) · Open Forum Infectious Diseases · doi:10.1093/ofid/ofx243 · Cited by 56 · see citing works
Repurposing Metformin in Nondiabetic People With HIV: Influence on Weight and Gut Microbiota
Isnard, S., Lin, J., Fombuena, B., Ouyang, J., Varin, T. V., Richard, C., Marette, A., Ramendra, R., Planas, D., Raymond Marchand, L., et al. (2020) · Open Forum Infectious Diseases · doi:10.1093/ofid/ofaa338 · Cited by 51 · see citing works
Self-citationOptimal screening and donor management in a public stool bank
Kazerouni, A., Burgess, J., Burns, L. J., & Wein, L. M. (2015) · Microbiome · doi:10.1186/s40168-015-0140-3 · Cited by 43 · see citing works
Hourigan, S. K., Ahn, M., Gibson, K. M., Pérez‐Losada, M., Felix, G., Weidner, M., Leibowitz, I., Niederhuber, J. E., Sears, C. L., Crandall, K. A., et al. (2019) · Open Forum Infectious Diseases · doi:10.1093/ofid/ofz379 · Cited by 43 · see citing works
Ninkov, M., Schmerk, C. L., Moradizadeh, M., Parvathy, S. N., Figueredo, R., Burton, J. P., Silverman, M., Fernandes, R., Vareki, S. M., & Haeryfar, S. M. M. (2022) · Cancer Immunology Immunotherapy · doi:10.1007/s00262-022-03329-8 · Cited by 32 · see citing works
Léo, S., Lazarević, V., Girard, M., Gaïa, N., Schrenzel, J., LASTOURS, V. D., Fantin, B., Bonten, M. J. M., Carmeli, Y., Rondinaud, E., et al. (2020) · Microorganisms · doi:10.3390/microorganisms8060941 · Cited by 31 · see citing works
Shaikh, F. Y., Gills, J. J., Mohammad, F., White, J. R., Stevens, C. M., Ding, H., Fu, J., Tam, A., Blosser, R. L., Domingue, J. C., et al. (2022) · Cancer Immunology, Immunotherapy · doi:10.1007/s00262-022-03169-6 · Cited by 30 · see citing works
Chen, M.-M., Liu, M., Li, C., Peng, S., Li, Y., Xu, X., Sun, M., & Sun, X. (2022) · Frontiers in Oncology · doi:10.3389/fonc.2022.913217 · Cited by 29 · see citing works
First clinical proof-of-concept that FMT can overcome resistance to ICIs
Elkrief, A., & Routy, B. (2021) · Nature Reviews Clinical Oncology · doi:10.1038/s41571-021-00502-3 · Cited by 23 · see citing works
Self-citationRoche’s anti-TIGIT drug suffers a phase III cancer setback
Mullard, A. (2022) · Nature Reviews Drug Discovery · doi:10.1038/d41573-022-00068-4 · Cited by 21 · see citing works
Williams, P. A., Zaidi, S. K., & Sengupta, R. (2022) · Clinical Cancer Research · doi:10.1158/1078-0432.ccr-22-2588 · Cited by 21 · see citing works
Katayama, Y., Yamada, T., Tanimura, K., Yoshimura, A., Takeda, T., Chihara, Y., Tamiya, N., Kaneko, Y., Uchino, J., & Takayama, K. (2019) · Thoracic Cancer · doi:10.1111/1759-7714.12969 · Cited by 20 · see citing works
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Mok, T. S. K., Wu, Y.-L. L. C., Watson Patricia, A., Zhang, J., Rangwala, R. A., & Junior, G. L. L. (2015) · Journal of Clinical Oncology · doi:10.1200/jco.2015.33.15_suppl.tps8105 · Cited by 17 · see citing works
Dai, C., & Liu, W.-X. (2021) · Inflammatory Bowel Diseases · doi:10.1093/ibd/izab265 · Cited by 17 · see citing works
Fernandes, R., Parvathy, S. N., Ernst, D. S., Haeryfar, M., Burton, J. P., Silverman, M., & Maleki, S. (2022) · Journal of Clinical Oncology · doi:10.1200/jco.2022.40.16_suppl.4553 · Cited by 17 · see citing works
Ianiro, G., Mullish, B. H., Iqbal, T. H., Terveer, E. M., Baunwall, S. M. D., Link, A., Sokol, H., Kupčinskas, J., Masucci, L., Sanguinetti, M., et al. (2022) · The Lancet. Gastroenterology & hepatology · doi:10.1016/s2468-1253(22)00305-3 · Cited by 15 · see citing works
Fecal microbiota transplantation followed by anti–PD-1 treatment in patients with advanced melanoma.
Miller, W. H., Routy, B., Jamal, R., Ernst, D. S., Logan, D., Esfahani, K., Bélanger, K., Elkrief, A., Lapointe, R., Thébault, P., et al. (2022) · Journal of Clinical Oncology · doi:10.1200/jco.2022.40.16_suppl.9533 · Cited by 11 · see citing works
Self-citationEnhanced donor screening for faecal microbial transplantation during COVID-19
Parvathy, S. N., Lenehan, J. G., Fernandes, R., Poutanen, S. M., Hota, S. S., Vareki, S. M., & Silverman, M. E. (2021) · Gut · doi:10.1136/gutjnl-2021-324593 · Cited by 10 · see citing works
Flagged first, then by citations
3 of the 105 references couldn’t be matched to a known paper.
Cited by
Sorted by citations
The Role of Fecal Microbiota Transplantation in IBD
Fanizzi, F., D’Amico, F., Bombassaro, I., Zilli, A., Furfaro, F., Parigi, T. L., Cicerone, C., Fiorino, G., Peyrin‐Biroulet, L., Danese, S., et al. (2024) · Microorganisms · doi:10.3390/microorganisms12091755 · Cited by 48 · see citing works
Jiang, H., & Zhang, Q. (2024) · Oncology Letters · doi:10.3892/ol.2024.14221 · Cited by 34 · see citing works
Gothandapani, D., & Makpol, S. (2023) · International Journal of Molecular Sciences · doi:10.3390/ijms241914667 · Cited by 27 · see citing works
Gut modulation to regulate NF-κB in colorectal and gastric cancer therapy and inflammation
Kearns, R. (2025) · Cancer Immunology Immunotherapy · doi:10.1007/s00262-025-04118-9 · Cited by 23 · see citing works
Unraveling the complexities of colorectal cancer and its promising therapies – An updated review
Saha, S., Ghosh, S., Ghosh, S., Nandi, S., & Nayak, A. (2024) · International Immunopharmacology · doi:10.1016/j.intimp.2024.113325 · Cited by 23 · see citing works
Microbiota-centered interventions to boost immune checkpoint blockade therapies
Almonte, A. A., Thomas, S., & Zitvogel, L. (2025) · Journal of Experimental Medicine · doi:10.1084/jem.20250378 · Cited by 19 · see citing works
Hu, D., Zhao, J., Zhang, H., Wang, G., & Gu, Z. (2023) · Life · doi:10.3390/life13071488 · Cited by 16 · see citing works
Zhang, W., Zhang, H., Gao, Y., Lei, J., & Suo, C. (2025) · Frontiers in Cellular and Infection Microbiology · doi:10.3389/fcimb.2025.1596688 · Cited by 12 · see citing works
Chen, M., & Bie, L. (2025) · Cancer Cell International · doi:10.1186/s12935-025-03745-7 · Cited by 10 · see citing works
Communication between gut microbiota-derived metabolites and the tumor microenvironment
Hu, X., Li, B., Li, Y., Liang, Y., & Huang, T. (2025) · Frontiers in Immunology · doi:10.3389/fimmu.2025.1649438 · Cited by 10 · see citing works
Hu, X., Wu, Q., Huang, L., Xu, J., He, X., & Wu, L. (2024) · Frontiers in Nutrition · doi:10.3389/fnut.2024.1465499 · Cited by 8 · see citing works
Cao, Y., Zhang, L., Xiong, F., Guo, X., Kan, X., Song, S., Liang, B., Liang, B., Li, Y., & Zheng, C. (2023) · Future Microbiology · doi:10.2217/fmb-2022-0234 · Cited by 8 · see citing works
Moutsoglou, D., Syal, A., Lopez, S., Nelson, E. C., Chen, L., Kabage, A. J., Fischer, M., Khoruts, A., Vaughn, B. P., & Staley, C. M. (2024) · Journal of Crohn s and Colitis · doi:10.1093/ecco-jcc/jjae142 · Cited by 8 · see citing works
Leveraging gut microbiota for enhanced immune checkpoint blockade in solid tumor therapy
Hu, J., Feng, T., Zhang, L., Zhou, Q., & Zhu, L. (2025) · Chinese Medical Journal · doi:10.1097/cm9.0000000000003687 · Cited by 7 · see citing works
Immunotherapy for Platinum-Resistant Ovarian Cancer as a Glimmer of Hope
Brancewicz, J., Padzińska-Pruszyńska, I. B., Kubiak, M., & Kucharzewska, P. (2025) · Cells · doi:10.3390/cells14130995 · Cited by 6 · see citing works
The role of microbiota in gastric cancer: A comprehensive review
Lei, C., Xu, Y., Zhang, S., Huang, C., & Qin, J. (2024) · Helicobacter · doi:10.1111/hel.13071 · Cited by 6 · see citing works
Fecal microbiota transplantation: from empirical remedy to precision medicine
Zhao, J., 樊翌明, Yang, K., & Gao, H. (2026) · Frontiers in Microbiomes · doi:10.3389/frmbi.2026.1863308 · Cited by 6 · see citing works
Intratumoral microbiota in cancer: molecular mechanism and therapeutic strategies
Yu, Y., Guo, Z., Luo, Z., Dian, Y., Yang, X., Chen, X., Zeng, F., & Deng, G. (2026) · Molecular Biomedicine · doi:10.1186/s43556-026-00473-w · Cited by 4 · see citing works
Kang, W., Zhang, Z., Li, W., Zhang, Q., Li, N., Jiang, Y., Zhang, J., & He, Y. (2026) · Frontiers in Immunology · doi:10.3389/fimmu.2026.1773002 · Cited by 3 · see citing works
Gut microbiota and metabolites: emerging prospects in the treatment of non-small cell lung cancer
Jiao, J.-M., Liu, C., Zang, D., & Chen, J. (2025) · Frontiers in Immunology · doi:10.3389/fimmu.2025.1638942 · Cited by 2 · see citing works
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The gut microbiome in colorectal cancer: molecular paradigms and translational frontiers
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Immune checkpoint inhibitors in dMMR-MSI-H colorectal cancer: rationale, progress and prospects
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Novel options for the management of C. difficile : a look into the future
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- Authors
- Jamal, R., Messaoudene, M., de Figuieredo, M., & Routy, B.
- Affiliations
- Centre Hospitalier de l’Université de Montréal (CA)
- Université de Montréal (CA)
- Corresponding author
- Routy, Bertrand
- Venue
- Seminars in Immunology
- Publisher
- Elsevier BV
- Published
- 2023-05
- Volume
- 67
- Pages
- 101754
- ISSN
- 1044-5323 (ISSN-L)
- OpenAlex
- W4361256393
- Cited by
- 31
- References
- 105
- Citations by year
- 2026: 12 · 2025: 9 · 2024: 7 · 2023: 3
- FWCI
- 1.01
- Type
- journal article
- Language
- en
- Open access
- closed
- Licence
- Locations
- Seminars in Immunology (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Canadian Institutes of Health Research
- Topics
- Health Sciences › Medicine › Oncology › Cancer Immunotherapy and Biomarkers
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Gut microbiota and health
- Health Sciences › Medicine › Infectious Diseases › Clostridium difficile and Clostridium perfringens research
- Keywords
- fecal microbiota transplantation, gut microbiota, cancer immunotherapy, immune checkpoint inhibitors, immune checkpoint inhibitor toxicity, Clostridium difficile, emerging pathogens, metagenomics
- MeSH terms
- Fecal Microbiota Transplantation, Immune Checkpoint Inhibitors, Animals, Humans, Neoplasms, Treatment Outcome, Mice, Microbiota
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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