Periodic Reporting for period 1 - IHMCSA (International Human Microbiome Coordination and Support Action)
Periodo di rendicontazione: 2021-05-01 al 2022-10-31
Humans are microbial, living in close functional interaction with their skin and mucosal microbiomes. Human-microbes symbiosis is a key factor for the maintenance of health and well-being. The profiling of microbiomes will be an essential feature of personalized preventive nutrition and medicine of the future. Europe has gained a leading position in microbiome research. However if this research is to achieve full impact, coordination needs to be in place and consensus built amongst all key actors at international level notably as regards i) clinical trial design and analytical standards, ii) definitions of healthy microbiomes as a function of numerous factors, accounting for confounders, iii) demonstrating causality of altered host-microbes interactions in disease and iv) processes for the development of clinically relevant, validated biomarkers.
The International Human Microbiome Coordination and Support Action (IHMCSA ; https://humanmicrobiomeaction.eu/) brings together a strong EU partnership and broad stakeholders group involving all the actors along the innovation chain, including citizens, to i) map the current scientific state-of-play ii) identify the path and actions required to achieve impact iii) build consensus on the priorities and means as part of a roadmap for EU microbiome science and its translation. This will lead to a set of recommendations, validated by the IHMCSA International Strategic Steering Committee, addressed to the European Commission, international research programmes, funding and regulatory agencies and our health system decision makers. To ensure further take-up and sustainability of these project outcomes, IHMCSA will promote via a strong dissemination programme, unified repositories for sharing standards, SOPs and data, as well as initiate the creation of the European Microbiome Centers Consortium, a world microbiome network of excellence. Thanks to IHMCSA, human-associated microbiomes will be recognized for their key role in ensuring the future of mankind.
The International Human Microbiome Coordination and Support Action (IHMCSA ; https://humanmicrobiomeaction.eu/) brings together a strong EU partnership and broad stakeholders group involving all the actors along the innovation chain, including citizens, to i) map the current scientific state-of-play ii) identify the path and actions required to achieve impact iii) build consensus on the priorities and means as part of a roadmap for EU microbiome science and its translation. This will lead to a set of recommendations, validated by the IHMCSA International Strategic Steering Committee, addressed to the European Commission, international research programmes, funding and regulatory agencies and our health system decision makers. To ensure further take-up and sustainability of these project outcomes, IHMCSA will promote via a strong dissemination programme, unified repositories for sharing standards, SOPs and data, as well as initiate the creation of the European Microbiome Centers Consortium, a world microbiome network of excellence. Thanks to IHMCSA, human-associated microbiomes will be recognized for their key role in ensuring the future of mankind.
For this first reporting period of 18 months, the IHMCSA partnership together with contributions from members of its international Stakeholders Advisory Board have prioritized the mapping of the state of play for activities covered by the two major pillars on i) standards for microbiome studies (from clinical trial design to sample management, omics data production and associated data-science) and ii) microbiome in health and disease (defining healthy microbiome, assessing causality and identifying signatures towards biomarker-design). The mapping relied on an assessment of existing material (literature, cohorts, clinical trials and data repositories, bioanalysis pipelines, ...) and high level expert workshops. It lead as anticipated to internal reports that will further form the basis for actions towards building consensus on necessary future developments and delivery of recommendations for the Strategic Research and Innovation Agenda for the Human microbiome field. Concerning the design of microbiome-related clinical trials, use of microbiome information in medical practice, and modalities for the assessment of causality, consensus among a large array of stakeholders will be formally assessed via Delphi surveys.
The IHMCSA partnership also specifically addresses ethical implications of the questions addressed as they concern the perceptions of humans as holobionts (intimate functional association with the microbiomes), and the possibility of using individual microbiome profiles - including self-assessment - towards preventive nutritional recommendations or precision medicine.
The IHMCSA partnership also addresses regulatory aspects as the microbiome field is challenging regulatory agencies by the insertion of novel live biological ‘actives’ (full human intestinal ecosystems or fractions therefrom) in the realm of Therapeutics. The rules to maintain a strong European potential to contribute to innovation being at stake, the IHMCSA partnership contributes to consultations and debates, as well as interactions with the SOHO group to propose expert vision on the microbiome-related topics/issues.
The IHMCSA partnership is already involved in communicating its processes and its contribution to knowledge and consensus building on the microbiome field.
Finally, the IHMCSA partnership is preparing the inception of the European Microbiome Centers Consortium as a means to structure the field and to ensure sustainability of its actions including implementations of recommendations / strategic research and innovation agenda derived from international consensus
The IHMCSA partnership also specifically addresses ethical implications of the questions addressed as they concern the perceptions of humans as holobionts (intimate functional association with the microbiomes), and the possibility of using individual microbiome profiles - including self-assessment - towards preventive nutritional recommendations or precision medicine.
The IHMCSA partnership also addresses regulatory aspects as the microbiome field is challenging regulatory agencies by the insertion of novel live biological ‘actives’ (full human intestinal ecosystems or fractions therefrom) in the realm of Therapeutics. The rules to maintain a strong European potential to contribute to innovation being at stake, the IHMCSA partnership contributes to consultations and debates, as well as interactions with the SOHO group to propose expert vision on the microbiome-related topics/issues.
The IHMCSA partnership is already involved in communicating its processes and its contribution to knowledge and consensus building on the microbiome field.
Finally, the IHMCSA partnership is preparing the inception of the European Microbiome Centers Consortium as a means to structure the field and to ensure sustainability of its actions including implementations of recommendations / strategic research and innovation agenda derived from international consensus
The aims and expected impacts of IHMCSA are to provide guidance/recommendations based on international agreement on:
- Proposed concrete methods, standards, procedures and in vivo models in order to improve harmonisation and increase comparability of metagenomics, metabolomics and human microbiome data from past, current and future projects in Europe and beyond.
- Means to provide definitive references of healthy human metagenomes. These should apply across various populations and help end-users and citizens to see which microbiome is healthy. It will also provide a guide for health professionals to evaluate preventive or therapeutic approaches to protect or restore the microbiota-host symbiosis.
- Means to provide more meaningful results through collaborative synergistic collection of microbiome data from different sources.
- Means to improve coherence and reduce overlap between national, EU and other funding in the area of human microbiome research, thus ensuring an efficient use of the available human and financial resources.
- Knowledge exchange and enhanced engagement of citizens, scientists and political stakeholders for priority health risks, in order to speed up the delivery of validated results.
- Means to promote an integration of metagenomics and human microbiome references into other multilateral co-operation areas or personalised medicine approaches.
- Proposed concrete methods, standards, procedures and in vivo models in order to improve harmonisation and increase comparability of metagenomics, metabolomics and human microbiome data from past, current and future projects in Europe and beyond.
- Means to provide definitive references of healthy human metagenomes. These should apply across various populations and help end-users and citizens to see which microbiome is healthy. It will also provide a guide for health professionals to evaluate preventive or therapeutic approaches to protect or restore the microbiota-host symbiosis.
- Means to provide more meaningful results through collaborative synergistic collection of microbiome data from different sources.
- Means to improve coherence and reduce overlap between national, EU and other funding in the area of human microbiome research, thus ensuring an efficient use of the available human and financial resources.
- Knowledge exchange and enhanced engagement of citizens, scientists and political stakeholders for priority health risks, in order to speed up the delivery of validated results.
- Means to promote an integration of metagenomics and human microbiome references into other multilateral co-operation areas or personalised medicine approaches.