Past, present, and future of microbiome-based therapies
Pilar Manrique , Ignacio Montero , Marta Fernandez-Gosende , Noelia Martinez , Claudio Hidalgo Cantabrana , David Rios-Covian
Microbiome Research Reports ›› 2024, Vol. 3 ›› Issue (2) : 23
Past, present, and future of microbiome-based therapies
Technological advances in studying the human microbiome in depth have enabled the identification of microbial signatures associated with health and disease. This confirms the crucial role of microbiota in maintaining homeostasis and the host health status. Nowadays, there are several ways to modulate the microbiota composition to effectively improve host health; therefore, the development of therapeutic treatments based on the gut microbiota is experiencing rapid growth. In this review, we summarize the influence of the gut microbiota on the development of infectious disease and cancer, which are two of the main targets of microbiome-based therapies currently being developed. We analyze the two-way interaction between the gut microbiota and traditional drugs in order to emphasize the influence of gut microbial composition on drug effectivity and treatment response. We explore the different strategies currently available for modulating this ecosystem to our benefit, ranging from 1st generation intervention strategies to more complex 2nd generation microbiome-based therapies and their regulatory framework. Lastly, we finish with a quick overview of what we believe is the future of these strategies, that is 3rd generation microbiome-based therapies developed with the use of artificial intelligence (AI) algorithms.
Microbiome-based therapies / microbiota / LBP / MBP / biological drugs
| [1] |
|
| [2] |
|
| [3] |
|
| [4] |
|
| [5] |
|
| [6] |
|
| [7] |
|
| [8] |
|
| [9] |
|
| [10] |
|
| [11] |
|
| [12] |
|
| [13] |
|
| [14] |
|
| [15] |
|
| [16] |
|
| [17] |
|
| [18] |
|
| [19] |
|
| [20] |
|
| [21] |
|
| [22] |
|
| [23] |
|
| [24] |
|
| [25] |
|
| [26] |
|
| [27] |
|
| [28] |
|
| [29] |
|
| [30] |
|
| [31] |
|
| [32] |
|
| [33] |
|
| [34] |
|
| [35] |
|
| [36] |
|
| [37] |
|
| [38] |
|
| [39] |
|
| [40] |
|
| [41] |
|
| [42] |
|
| [43] |
|
| [44] |
Rekdal VM, Bess EN, Bisanz JE, Turnbaugh PJ, Balskus EP. Discovery and inhibition of an interspecies gut bacterial pathway for Levodopa metabolism.Science2019;364:eaau6323 PMCID:PMC7745125 |
| [45] |
|
| [46] |
|
| [47] |
|
| [48] |
|
| [49] |
|
| [50] |
|
| [51] |
|
| [52] |
|
| [53] |
|
| [54] |
|
| [55] |
|
| [56] |
|
| [57] |
|
| [58] |
|
| [59] |
|
| [60] |
|
| [61] |
|
| [62] |
|
| [63] |
van der Hee B, Wells JM. Microbial regulation of host physiology by short-chain fatty acids.Trends Microbiol2021;29:700-12 |
| [64] |
|
| [65] |
|
| [66] |
|
| [67] |
|
| [68] |
|
| [69] |
|
| [70] |
|
| [71] |
|
| [72] |
|
| [73] |
De Filippis F, Vitaglione P, Cuomo R, Berni Canani R, Ercolini D. Dietary interventions to modulate the gut microbiome - how far away are we from precision medicine.Inflamm Bowel Dis2018;24:2142-54 |
| [74] |
|
| [75] |
|
| [76] |
|
| [77] |
|
| [78] |
|
| [79] |
|
| [80] |
|
| [81] |
|
| [82] |
|
| [83] |
|
| [84] |
|
| [85] |
|
| [86] |
|
| [87] |
|
| [88] |
|
| [89] |
|
| [90] |
|
| [91] |
|
| [92] |
|
| [93] |
|
| [94] |
EFSA Panel on Biological Hazards (BIOHAZ); Koutsoumanis K, Allende A, Alvarez-Ordóñez A, et al. Update of the list of qualified presumption of safety (QPS) recommended microbiological agents intentionally added to food or feed as notified to EFSA 18: suitability of taxonomic units notified to EFSA until March 2023. EFSA J 2023;21:e08092. |
| [95] |
|
| [96] |
|
| [97] |
|
| [98] |
Gomez Quintero DF, Kok CR, Hutkins R. The future of synbiotics: rational formulation and design.Front Microbiol2022;13:919725 PMCID:PMC9354465 |
| [99] |
|
| [100] |
|
| [101] |
|
| [102] |
|
| [103] |
|
| [104] |
|
| [105] |
|
| [106] |
|
| [107] |
|
| [108] |
|
| [109] |
|
| [110] |
|
| [111] |
|
| [112] |
da Silva JTS, Nagata CLP. Efficacy of prebiotics in promoting a healthy gut microbiota in adults and elderly persons in the community.Nutrire2021;46:18 |
| [113] |
|
| [114] |
|
| [115] |
|
| [116] |
Early clinical trials with live biotherapeutic products: chemistry, manufacturing, and control information. 2016. Available from: https://www.fda.gov/files/vaccines,%20blood%20&%20biologics/published/Early-Clinical-Trials-With-Live-Biotherapeutic-Products--Chemistry--Manufacturing--and-Control-Information--Guidance-for-Industry.pdf. [Last accessed on 15 Mar 2024] |
| [117] |
|
| [118] |
|
| [119] |
European Directorate for the Quality of Medicines & HealthCare (EDQM). Live Biotherapeutic Products (LBPs): European Pharmacopoeia Commission sets unprecedented quality requirements. Available from: https://www.edqm.eu/en/w/live-biotherapeutic-products-lbps-european-pharmacopoeia-commission-sets-unprecedented-quality-requirements. [Last accessed on 15 Mar 2024] |
| [120] |
de Vos WM, Tilg H, Van Hul M, Cani PD. Gut microbiome and health: mechanistic insights.Gut2022;71:1020-32 PMCID:PMC8995832 |
| [121] |
|
| [122] |
|
| [123] |
|
| [124] |
|
| [125] |
|
| [126] |
|
| [127] |
|
| [128] |
|
| [129] |
|
| [130] |
|
| [131] |
|
| [132] |
|
| [133] |
|
| [134] |
|
| [135] |
|
| [136] |
|
| [137] |
|
| [138] |
|
| [139] |
|
| [140] |
|
| [141] |
|
| [142] |
|
| [143] |
|
| [144] |
|
| [145] |
|
| [146] |
|
| [147] |
|
| [148] |
|
| [149] |
|
| [150] |
|
| [151] |
|
| [152] |
|
| [153] |
Faecal microbiota transplantation. EU-IN Horizon Scanning Report. 2022. Available from: https://www.ema.europa.eu/en/documents/report/faecal-microbiota-transplantation-eu-horizon-scanning-report_en.pdf. [Last accessed on 15 Mar 2024] |
| [154] |
Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC Relevant text for EEA purposes. Available from: http://data.europa.eu/eli/reg/2014/536/oj/spa. [Last accessed on 15 Mar 2024] |
| [155] |
Integrated addendum to ICH E6(R1): guideline for good clinical practice E6(R2). Available from: https://database.ich.org/sites/default/files/E6_R2_Addendum.pdf. [Last accessed on 15 Mar 2024] |
| [156] |
Guideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials. Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-requirements-quality-documentation-concerning-biological-investigational-medicinal-products-clinical-trials-revision-2_en.pdf. [Last accessed on 15 Mar 2024] |
| [157] |
FDA. FDA approves first orally administered fecal microbiota product for the prevention of recurrence of Clostridioides difficile infection. Available from: https://www.fda.gov/news-events/press-announcements/fda-approves-first-orally-administered-fecal-microbiota-product-prevention-recurrence-clostridioides. [Last accessed on 15 Mar 2024] |
| [158] |
BiomeBank. BiomeBank announces world first regulatory approval for donor derived microbiome drug. 2022. Available from: https://www.biomebank.com/news/biomebank-announces-world-first-regulatory-approval-for-donor-derived-microbiome-drug/. [Last accessed on 15 Mar 2024] |
| [159] |
FDA. VOWST. Available from: https://www.fda.gov/vaccines-blood-biologics/vowst. [Last accessed on 15 Mar 2024] |
| [160] |
|
| [161] |
|
| [162] |
|
| [163] |
|
| [164] |
MIT Professional Education. Artificial intelligence vs machine learning: what’s the difference? Available from: https://professionalprograms.mit.edu/blog/technology/machine-learning-vs-artificial-intelligence/. [Last accessed on 15 Mar 2024] |
| [165] |
|
| [166] |
|
| [167] |
|
| [168] |
|
| [169] |
|
| [170] |
|
| [171] |
|
| [172] |
|
| [173] |
|
| [174] |
|
| [175] |
|
/
| 〈 |
|
〉 |