Live biotherapeutics and medicinal microbiome products
- Submission status
- Open
- Submission deadline
Non-communicable diseases and disorders are on the rise, with many, such as obesity, type II diabetes, autoimmune defects, chronic immune disorders, allergies, and fertility and pregnancy problems, being associated with the quality of microbiota.
Whilst there is still some debate on the definition of healthy microbiota - particularly as it relates to various body sites - there is consensus regarding the importance of factors such as diversity, resilience, metabolic flexibility, and the immune impact of microbiota on the human host.
Given the complexity and variability of the microbiota, identifying individual microorganisms (strains, species, genera, etc.) and the role that they play in non-communicable diseases (either positive or negative) is extremely challenging. However, approaches such as fecal microbiota transplants (FMT) have been successful in reducing the burden of some non-communicable diseases. Despite potential benefits, introduction of largely undefined microbial consortia present certain risks and have proven to be a regulatory challenge. This has prompted a move towards live biotherapeutics, which are live microorganisms (individually or in defined consortia) that are used for the prevention, cure or treatment of disease.
The use of live biotherapeutic products to treat disease also presents a regulatory challenge. In 2023, the FDA approved two live biotherapeutic products for the treatment and prevention of recurrent Clostridioides difficile (Cdif) infections, with more dossiers under preparation for evaluation by drug authorities in various therapeutic areas. Given the interest in live biotherapeutic products, it is important that a robust regulatory framework be defined.
This Collection welcomes contributions on recent developments in the utilization of live biotherapeutics and medicinal microbiome products for the treatment or prevention of diseases. We are particularly interested in difficult-to-treat non-communicable diseases whose pathogenesis is associated with microbiota.
We welcome submissions which address the following questions:
- What are the core microorganisms absolutely necessary to maintain a healthy life?
- Are numbers crucial, or do pathways and functionalities play a more significant role?
- What (new) tools, methods and research areas do we need to develop further to allow for a more effective development of this incredibly important axis in medicine?
- Is the regulation ready to deal with these new developments?
- Do we have enough (standardised) data to make the next jump?
- How can we adequately address the safety concerns for approaches affecting the microbiota of various body parts, such as the lungs, nose, oral cavity, vagina, and skin, versus the gut?
- Can the traditional probiotics or prebiotics fill in certain roles?
- What scientific level of proof is necessary and can the traditional schemes for clinical research be maintained?
This Collection supports and amplifies research related to SDG 3, SDG 4, and SDG 9.
Editors
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Sarah Lebeer, PhD
University of Antwerp, Department of Bioscience Engineering, Groenenborgerlaan, Antwerp, Belgium.
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Bruno Pot, PhD
Vrije Universiteit Brussel, Brussels, Belgium Yakult Europe BV, Almere, The Netherlands
Sarah Lebeer, PhD, University of Antwerp, Department of Bioscience Engineering, Antwerp, Belgium.
Sarah Lebeer is a full professor in applied microbiology and biotechnology at the Department of Bioscience Engineering, University of Antwerp, Belgium. Trained as a Bioscience Engineer in Cell and Gene Biotechnology, she earned her PhD in bacterial genetics and probiotics at the University of Leuven, Belgium, followed by a postdoc on mucosal immunology and vaginal lactobacilli at the same institution.
Joining the University of Antwerp in November 2011, Sarah established a pioneering research line on beneficial microbiology for humans, plants, and the planet. As an academic board member of the International Scientific Association on Probiotics and Prebiotics (https://www.isappscience.org) since 2016, she contributes to advancing knowledge in this field. In 2019, Sarah secured an ERC research grant (Lacto-Be, grant agreement ID: 852600) focusing on the ecology, evolution, and beneficial potential of lactobacilli.
Sarah's research, conducted with her dedicated team, centers on the microbiome of various mucosal surfaces in humans (particularly the vagina, skin, and respiratory tract), animals and plants, including fermented plants and vegetables. Their objective is to identify commensals with potential applications as probiotics, life biotherapeutic products, and sustainable bio-based solutions for humans, plants, animals, and the environment.
Leading the Isala citizen-science project on the vaginal microbiome and women's health (https://isala.be/en), Sarah actively promotes diversity and awareness in microbiome research. The project, currently expanding globally with numerous sisterhood initiatives, aims to make impactful contributions to understanding and improving women's health.
Motivated not only by the intricacies of the microbiome but also by a broader commitment to fostering diversity, Sarah has guided over 100 students, from bachelor to PhD level, from around the world. Her dedication extends not only to understanding and enhancing the diversity of the microbiome at the micro-level but also to actively promoting inclusivity among researchers and citizens contributing to her projects.
Bruno Pot, PhD, Science Director Europe at Yakult Europe BV, The Netherlands, Food Microbiology Professor at the Vrije Universiteit Brussel, Belgium.
Bruno Pot made a PhD in microbial taxonomy at the University of Gent, Belgium. In subsequent postdocs he performed research on lactic acid bacteria. In 1997 he joined the science department of the company Yakult as science manager for the Benelux. He worked as Research Director at the Institut Pasteur in Lille, France, from 2001 till 2016. During that time he was also Director of Business Development at the bioinformatics company Applied Maths NV in Belgium and Professor at the Vrije Universiteit Brussel for courses in food microbiology – ecology and - hygiene. His major research topics have been lactic acid bacteria, probiotics, bacteria-host interaction, bioinformatics of microbiological data and health claim substantiation. Since November 2016 Bruno is back with Yakult as Science Director for Europe. He is a member of the Taxonomic Subcommittee for Lactobacillus, Bifidobacterium and related taxa since 1987, former ISAPP Board member, former president of the Pharmabiotic Research Institute (currently VP) in France, Board member of the LABIP and ENLP, and Chair of the Board of ILSI-Europe. He authored or co-authored >250 scientific articles and >20 book chapters.
