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International consensus conference on stool banking for faecal microbiota transplantation in clinical practice
Open accessAbstract
infection (CDI), its widespread dissemination is limited by several obstacles, including lack of dedicated centres, difficulties with donor recruitment and complexities related to regulation and safety monitoring. Given the considerable burden of CDI on global healthcare systems, FMT should be widely available to most centres.Stool banks may guarantee reliable, timely and equitable access to FMT for patients and a traceable workflow that ensures safety and quality of procedures. In this consensus project, FMT experts from Europe, North America and Australia gathered and released statements on the following issues related to the stool banking: general principles, objectives and organisation of the stool bank; selection and screening of donors; collection, preparation and storage of faeces; services and clients; registries, monitoring of outcomes and ethical issues; and the evolving role of FMT in clinical practice,Consensus on each statement was achieved through a Delphi process and then in a plenary face-to-face meeting. For each key issue, the best available evidence was assessed, with the aim of providing guidance for the development of stool banks in order to promote accessibility to FMT in clinical practice.
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“Both the increase in clinical requests for FMT to prevent rCDI and the high level of required quality controls have led to the development of stool banks that provide widespread and equitable access to FMT together with high safety, quality, and traceable workflows. 22”
From Key determinants of success in fecal microbiota transplantation: From microbiome to clinic (2023) · cites this paper as [22]
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“121 It has been suggested that the use of feces from multiple healthy donors to enrich the microbiota composition may enhance the efficacy of FMT, whether by infusion or ingestion.”
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“Finally, adding to the existing challenges, FMT is regulated differently by country, and has an uncertain regulatory future in the United States [65].”
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“Published guidance from consensus conferences on donor identification and screening, optimal FMT practices and the safe operation of stool banks have aimed to establish best practices in FMT.8,9 Although adverse events related to the procedure must be reported when FMT is being performed under FDA IND applications, th…”
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“[93,94] Furthermore, the true potential of FMT in this setting remains unclear, with”
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“One scenario is the patient-selected donor through which the patient introduces an exclusive donor and further stool screening is done by physicians while the other proposed scenario is the stool banking, a seemingly cost-effective approach offering pre-screened frozen stool of more consistent and stringent manufactur…”
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“Pregnancy is considered a contraindication for FMT in most guidelines [25], and studies of FMT during pregnancy are scarce [6].”
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“In recent years, progress on the standardization of FMT procedures has accelerated [19–21] and with further studies on the way, the variety of opinions captured in the survey might eventually converge.”
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“Second, the weight of faeces required for FMT is still a matter of debate; although some studies have suggested that a faecal weight of 12.5 to 25 g may be sufficient [10], some retrospective cohorts have suggested a loss of efficacy below 50 g [29].”
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“In summary, it is necessary to establish a comprehensive protocol, including donor selection, FMT preparation, and recipient evaluation, enhancing the effectiveness and safety of FMT [73].”
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“[38], including difficulties with donor recruitment, lack of dedicated centers and issues pertaining to safety monitoring and regulation, hence, the proposal for the provision of stool banks to bridge the gap of FMT in clinical practice.”
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Self-citationNanjing Consensus II on Washed Microbiota Transplantation: Statements From the CHINAGUT Conference
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“As the donor of faecal transplant in the present study met all the requirements [35] and the examined samples had the bacterial composition of healthy human gut without detecting any pathogenic species, we concluded that donor was a suitable candidate for transplant preparation according to a standard protocol [36].”
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“Donor testing was performed following international guidelines for fecal donor screening, as described in detail elsewhere [34].”
BackgroundMethodSelf-citationJouhten, H., Ronkainen, A., Aakko, J., Salminen, S., Mattila, E. J., Arkkila, P., & Satokari, R. M. (2020) · Frontiers in Microbiology · doi:10.3389/fmicb.2020.01663 · Cited by 10
Self-citationFaecal microbiota transplantation and the patient experience: A systematic review
Guilfoyle, J., Considine, J., & Bouchoucha, S. (2020) · Journal of Clinical Nursing · doi:10.1111/jocn.15625 · Cited by 9
Clinical management of severe, fulminant, and refractoryClostridioides difficileinfection
Cheng, Y., & Fischer, M. (2020) · Expert Review of Anti-infective Therapy · doi:10.1080/14787210.2020.1730814 · Cited by 9
“clinical practice [83] or the International consensus conference on stool banking for feacal microbiota transplantation [84].”
BackgroundSelf-citationStool banking for fecal microbiota transplantation: ready for prime time?
Saha, S., & Khanna, S. (2021) · HepatoBiliary Surgery and Nutrition · doi:10.21037/hbsn-20-371 · Cited by 9
The role of the gut microbiome in regulating the response to immune checkpoint inhibitor therapy
Dean, N. J., d’Arienzo, P. D., Ibraheim, H., Lee, K. A., Olsson-Brown, A. C., Pinato, D. J., & Powell, N. (2024) · Best Practice & Research Clinical Gastroenterology · doi:10.1016/j.bpg.2024.101944 · Cited by 9
Arcay, R. M., Barceló‐Nicolau, M., Suárez-Bode, L., Martín, L., Reigada, R., Höring, M., Liebisch, G., Garrido, C., Cabot, G., Vílchez, H., et al. (2024) · mBio · doi:10.1128/mbio.01347-24 · Cited by 8
Kabage, A. J., Haselhorst, P. J., & Khoruts, A. (2025) · Gut Microbes · doi:10.1080/19490976.2025.2508950 · Cited by 8
“The poor yield of this approach was suggested by a surprisingly generous allowance for obese donors with a body mass index up to 35 kg/m 2 , which is contrary to consensus guidelines for donor selection, 25,26,27 and a growing financial incentive.”
Fecal microbiota transplantation: A promising treatment strategy for chronic liver disease
Ma, L., Zhang, M., Xu, Y., Hao, Y.-X., Niu, X.-X., Li, Y., & Xing, H. (2025) · World Journal of Gastroenterology · doi:10.3748/wjg.v31.i28.105089 · Cited by 13
Gong, J., Liu, Y., & Huang, L. (2025) · Frontiers in Microbiology · doi:10.3389/fmicb.2025.1637673 · Cited by 11
Dietary Intakes of Recipients of Faecal Microbiota Transplantation: An Observational Pilot Study
Clancy, A. K., Lee, C., Hamblin, H. S., Gunaratne, A. W., Busque, A. L., Beck, E. J., Dawson, M. V. M., & Borody, T. J. (2021) · Nutrients · doi:10.3390/nu13051487 · Cited by 8
Gut microbiota in inflammatory bowel disease: a target for therapy not to be missed
LARUSSA, T., Abenavoli, L., FABIANO, G., MANCUSO, M. A., POLIMENI, N., DUMITRASCU, D. L., & Luzza, F. (2022) · Minerva Gastroenterology · doi:10.23736/s2724-5985.21.02907-7 · Cited by 8
Barko, P. C., Nguyen-Edquilang, J., Williams, D. A., & Gal, A. (2024) · PLoS ONE · doi:10.1371/journal.pone.0294730 · Cited by 8
Onifade, I. A., Sunbare-Funto, O. J., Mbah, C. G., Ajibade, O. A., Oyawoye, O. M., Aborode, A. T., Ogunleye, S. C., Jamiu, A. T., Bolarinwa, B., Abanikannda, M. F., et al. (2024) · Advances in Biomarker Sciences and Technology · doi:10.1016/j.abst.2024.02.001 · Cited by 8
Bibliometric and visual analysis of fecal microbiota transplantation research from 2012 to 2021
Zhang, F., Yang, P., Chen, Y., Wang, R., Liu, B., Wang, J., Yuan, M., & Zhang, L. (2022) · Frontiers in Cellular and Infection Microbiology · doi:10.3389/fcimb.2022.1057492 · Cited by 9
“, 2020), operating procedures (Cammarota et al., 2019), and administration routes (Ross and Reveles, 2020; Halaweish et al.”
BackgroundInfluentialFecal Microbiota Transplantation Research over the Past Decade: Current Status and Trends
Hao, S., Yang, S., Zhang, N., & Cheng, H.-J. (2023) · Canadian Journal of Infectious Diseases and Medical Microbiology · doi:10.1155/2023/6981721 · Cited by 8
“Notably, most of the top 10 authors participated in the formation of the FMT-related consensus [41, 70].”
Seo, H., Chin, H. S., Kim, Y.-H., Moon, H. S., Kim, K., Nguyen, L. P., & Yong, D. (2021) · Annals of Laboratory Medicine · doi:10.3343/alm.2021.41.4.424 · Cited by 8
“Many European and North American fecal microbiota banks have recently reported their donor screening outcomes, and these data have provided insights for establishing evidencebased FMT consensus reports [4-10, 12].”
BackgroundLong-term stability and efficacy of frozen fecal microbiota transplant (FMT) product at 24 months
Facchin, S., Cardin, R., Patuzzi, I., Carlotto, C., Minotto, M., Barberio, B., Zingone, F., Besutti, V. M., Castagliuolo, I., Cattelan, A. M., et al. (2024) · Digestive and Liver Disease · doi:10.1016/j.dld.2024.11.025 · Cited by 7
Microbiome Therapeutics for Clostridioides difficile Infection
Lucky, C. W., Medernach, R. L., Kelly, B. J., Kwon, J. H., & Woodworth, M. H. (2025) · Infectious Disease Clinics of North America · doi:10.1016/j.idc.2025.07.007 · Cited by 8
Chen, J., Chiu, C., Chen, C., Chen, Y.-C., Yeh, P., Kuo, C., Chiu, C., Cheng, H., Pan, Y., & Le, P. (2024) · Biomedicines · doi:10.3390/biomedicines12071396 · Cited by 7
“Fecal microbiota transplantation (FMT) is an effective and safe treatment for refractory or recurrent Clostridioides difficile infection (rrCDI) [9,26–30], endorsed by international guidelines [10,15,31–36].”
BackgroundZhao, J., Zhang, Y., Wang, X., Zou, P., Zhao, Z., Mei, H., Liu, Y., Su, N., Zhu, Y., Wang, B., et al. (2024) · Helicobacter · doi:10.1111/hel.13079 · Cited by 7
“26,27 The criteria include: no history of using antibiotics, proton pump inhibitors, bismuth agents, laxatives, probiotics, immunosup-pressants, chemotherapy medications, etc. in the last 3 months; no known history of infectious disorders, such as H. pylori infection; no systemic illness that…”
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
Self-citationMultimodal Approach to Assessment of Fecal Microbiota Donors based on Three Complementary Methods
Biliński, J., Dziurzyński, M., Grzesiowski, P., Podsiadły, E., Stelmaszczyk‐Emmel, A., Dzieciątkowski, T., Dziewit, Ł., & Basak, G. W. (2020) · Journal of Clinical Medicine · doi:10.3390/jcm9072036 · Cited by 7
SARS-CoV-2 vaccines and donor recruitment for FMT
Ianiro, G., Mullish, B. H., Hvas, C. L., Segal, J. P., Kuijper, E. J., Costello, S. P., Kelly, C. R., Allegretti, J. R., Fischer, M., Iqbal, T. H., et al. (2021) · The Lancet. Gastroenterology & hepatology · doi:10.1016/s2468-1253(21)00032-7 · Cited by 7
Self-citationWang, M., Xie, X., Zhao, S., Han, W., & Zhang, Y. (2022) · Frontiers in Microbiology · doi:10.3389/fmicb.2022.990800 · Cited by 7
“org for its modernization are being updated and standardized (Table 5; Supplementary Table 3; Zhang et al., 2018; Cammarota et al., 2019).”
BackgroundFactors of faecal microbiota transplantation applied to cancer management
Liu, Y.-H., Chen, J., Chen, X., & Liu, H. (2024) · Journal of drug targeting · doi:10.1080/1061186x.2023.2299724 · Cited by 6
“…FMt-related data and issues in clinical practice, providing guidance on the general organisation and standards required for centralised stool banks [84]. in general, there is a complete and standardised manufacturing model for centralised stool banks that addresses issues from the collection of…”
BackgroundBottino, P., Vay, D., Leli, C., Ferrara, L., Pizzo, V., Gotta, F., Raiteri, A., Rapallo, F., Roveta, A., Maconi, A., et al. (2024) · Microorganisms · doi:10.3390/microorganisms12071294 · Cited by 6
“The preparation and storing of Human Fecal Microbiota (HFM) for FMT purposes must be carried out following the indications of scientific societies in order to respect the requested standards of safety and traceability [1].”
BackgroundMethodInfluentialBénard, M. V., de Bruijn, C. M. A., Matamoros, S., Wentink-Bonnema, E. M., Benninga, M. A., Ponsioen, C. Y., & Zonneveld, R. (2025) · European Journal of Clinical Microbiology & Infectious Diseases · doi:10.1007/s10096-025-05124-6 · Cited by 6
“International guidelines for FMT donor screening differ in their recommendations to screen for Blastocystis spp. and exclusion of donors when present [ 14, 21, 45].”
Wang, Y., Li, X., & Gao, F. (2025) · Frontiers in Immunology · doi:10.3389/fimmu.2025.1549865 · Cited by 7
“…dif fi cile infection (CDI), its wide dissemination is restricted by several obstacles, including the lack of specialized centers, dif fi culties in donor recruitment, and the complexity associated with regulatory and safety monitoring, which makes it dif fi cult to de fi ne its precise function (83).”
Dry alginate beads for fecal microbiota transplantation: From model strains to fecal samples
Rakotonirina, A., Galperine, T. K., Audry, M., Kroemer, M., Ballif, A., Carrez, L., Sadeghipour, F., Schrenzel, J., Guery, B. P., & Allémann, É. (2023) · International Journal of Pharmaceutics · doi:10.1016/j.ijpharm.2023.122961 · Cited by 6
Fäkaler Mikrobiota-Transfer (FMT) in Deutschland – Status und Perspektive
Stallmach, A., von Müller, L., Storr, M., Link, A., Konturek, P. C., Solbach, P. C., Weiss, K. H., Wahler, S., & Vehreschild, M. J. G. T. (2023) · Zeitschrift für Gastroenterologie · doi:10.1055/a-2075-2725 · Cited by 6
Self-citationSintes, R., McLellan, P., Navelli, G., Landman, C., Delage, S., Truong, S., Benech, N., Kapel, N., Sabater, A. M., Schnuriger, A., et al. (2024) · Antimicrobial Agents and Chemotherapy · doi:10.1128/aac.00734-24 · Cited by 6
Self-citationCibulková, I., Řehořová, V., Soukupova, H., Waldauf, P., Cahová, M., Maňák, J., Matějovič, M., & Duška, F. (2024) · PLoS ONE · doi:10.1371/journal.pone.0310180 · Cited by 7
Hvas, C. L., Baunwall, S. M. D., & Erikstrup, C. (2020) · EClinicalMedicine · doi:10.1016/j.eclinm.2020.100436 · Cited by 6
“A technical guide issued by the European Council [3] and a recent international consensus conference describe in detail how safety and quality measures may be applied according to tissue and cells standards [4].”
BackgroundLong, A. E., Pitta, D., Hennessy, M. L., Indugu, N., Vecchiarelli, B., Luethy, D., Aceto, H. W., & Hurcombe, S. D. A. (2024) · BMC Veterinary Research · doi:10.1186/s12917-024-04166-w · Cited by 7
“…of 10% glycerol, 62.5 g of fresh stool, 162.5 mL of saline, and 25 mL of glycerol (85% glycerol solution; Honeywell Riedel-de Haën, Mus-kegon, MI, USA) were added to the second blender and blended at high speed for approximately 1 min; this was done simultaneously with the saline-only slurry [59].”
MethodInfluentialHyde, M. K., & Masser, B. (2020) · Transfusion · doi:10.1111/trf.16109 · Cited by 5
“These criteria included being eligible to donate blood, being in good health, normal weight, not currently taking medication, and no chronic digestive disorder or condition affecting BMs.10 Given recent international consensus statements that provide guidelines for donor age,10 we limited analysis to participants aged…”
BackgroundClinical Parasitology and Parasitome Maps as Old and New Tools to Improve Clinical Microbiomics
Pane, S., Ristori, M. V., Gardini, S., Russo, A., CHIERICO, F. D., & Putignani, L. (2021) · Pathogens · doi:10.3390/pathogens10121550 · Cited by 6
“stercoralis) [102], and particular attention is necessary for the parasitological screening of donors when recipients are children [103].”
BackgroundSelf-citationDing, X. L., Yang, X., & Wang, H. (2020) · Medicine in Microecology · doi:10.1016/j.medmic.2020.100028 · Cited by 6
Metadata
- Authors
- Cammarota, G., Ianiro, G., Kelly, C. R., Mullish, B. H., Allegretti, J. R., Kassam, Z., Putignani, L., Fischer, M., Keller, J. J., Costello, S. P., Sokol, H., Kump, P., Satokari, R., Kahn, S. A., Kao, D., Arkkila, P., Kuijper, E. J., Vehreschild, M. J. G., Pintus, C., Lopetuso, L., Masucci, L., Scaldaferri, F., Terveer, E. M., Nieuwdorp, M., López-Sanromán, A., Kupcinskas, J., Hart, A., Tilg, H., & Gasbarrini, A.
- Affiliations
- Agostino Gemelli University Polyclinic (IT)
- Brown University (US)
- Philipps University of Marburg (DE)
- Brigham and Women's Hospital (US)
- OpenBiome (US)
- Bambino Gesù Children's Hospital (IT)
- Indiana University Indianapolis (US)
- Leiden University Medical Center (NL)
- Queen Elizabeth Hospital (AU)
- Inserm (FR)
- Medical University of Graz (AT)
- University of Helsinki (FI)
- Boston Children's Hospital (US)
- University of Alberta (CA)
- University Hospital Cologne (DE)
- Tissues and Cells Area, Italian National Transplant Center, Rome, Italy
- Amsterdam UMC Location University of Amsterdam (NL)
- Gastroenterology and Hepatology Department, Hospital Universitario Ramon y Cajal, Madrid, Spain
- Department of Gastroenterology, Institute for Digestive Research, Medical Academy, Lithuanian University of Health Sciences, Kaunas, Lithuania
- St Mark's Hospital (GB)
- Innsbruck Medical University (AT)
- Corresponding author
- Cammarota, Giovanni
- ORCID
- Cammarota, Giovanni
- Ianiro, Gianluca
- Kelly, Colleen R
- Mullish, Benjamin H
- Allegretti, Jessica R
- Kassam, Zain
- Putignani, Lorenza
- Fischer, Monika
- Keller, Josbert J
- Costello, Samuel Paul
- Sokol, Harry
- Satokari, Reetta
- Kahn, Stacy A
- Kao, Dina
- Arkkila, Perttu
- Kuijper, Ed J
- Vehreschild, Maria J GT
- Lopetuso, Loris
- Masucci, Luca
- Scaldaferri, Franco
- Terveer, E M
- Nieuwdorp, Max
- Hart, Ailsa
- Tilg, Herbert
- Gasbarrini, Antonio
- Venue
- Gut
- Publisher
- BMJ
- Published
- 2019-09-28
- Volume
- 68
- Issue
- 12
- Pages
- 2111-2121
- ISSN
- 0017-5749 (ISSN-L)
- 1468-3288
- PMC
- PMC6872442
- OpenAlex
- W2976599382
- Cited by
- 506
- References
- 109
- Citations by year
- 2026: 74 · 2025: 63 · 2024: 87 · 2023: 61 · 2022: 57 · 2021: 73 · 2020: 86 · 2019: 5
- FWCI
- 42.36
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- cc-by-nc
- Locations
- Gut (publishedVersion, cc-by-nc)
- PubMed Central (publishedVersion, cc-by-nc)
- PubMed (publishedVersion)
- Kölner Universitäts PublikationsServer (Universität zu Köln) (publishedVersion)
- Amsterdam UMC (VU Amsterdam) - Institutional Repository (publishedVersion, other-oa)
- Pure Amsterdam UMC (submittedVersion, cc-by)
- Data Archiving and Networked Services (DANS) (submittedVersion, other-oa)
- Data Archiving and Networked Services (DANS) (submittedVersion)
- HAL (submittedVersion)
- Leiden Repository (Leiden University) (submittedVersion)
- Työväentutkimus Vuosikirja (submittedVersion)
- Lithuanian University of Health Sciences (submittedVersion)
- HighWire Press Open Archive (submittedVersion)
- PubliCatt (Università Cattolica del Sacro Cuore) (submittedVersion, other-oa)
- Spiral (Imperial College London) (submittedVersion, cc-by-nc)
- Topics
- Health Sciences › Medicine › Infectious Diseases › Clostridium difficile and Clostridium perfringens research
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Gut microbiota and health
- Health Sciences › Medicine › Gastroenterology › Gastrointestinal motility and disorders
- Keywords
- fecal microbiota transplantation, Clostridium difficile infection, donor screening, donor recruitment, safety monitoring
- MeSH terms
- Gastrointestinal Microbiome, Fecal Microbiota Transplantation, Clostridium Infections, Humans, Specimen Handling, Clostridioides difficile, Consensus, Donor Selection
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