ArticleFrontiers in medicine2020
Live Biotherapeutic Products, A Road Map for Safety Assessment.
Article in Frontiers in medicine, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 62 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
62 citing papers in PubMed, 101 citations in OpenAlex.
- Effect of probiotics derivatives (postbiotics and metabiotics) on glycemic control in individuals with type 2 diabetes: a randomized clinical trial (DELI_Diab study).Frontiers in endocrinology · 2026Trial
- Intestinal Microbial Composition of Children in a Randomized Controlled Trial of Probiotics to Treat Acute Gastroenteritis.Frontiers in cellular and infection microbiology · 2022Trial
- Genome-integrated engineering ofSynthetic and systems biotechnology · 2027Article
- Single-Step Chromosomal Engineering Integrates Biocontainment and Therapeutic Function for Regulatory-Oriented Live Biotherapeutic Chassis Design.Pharmaceutics · 2026Article
- A Microbial Odyssey: Reshaping Probiotic Destinies through Advanced Delivery Technologies.Probiotics and antimicrobial proteins · 2026Review
- Bioengineering Interventions to Enhance the Capacity of the Gut Microbiota in Controlling Food Allergies.Life (Basel, Switzerland) · 2026Review
- Current Concepts in Probiotic Safety and Efficacy.Nutrients · 2026Review
- Towards a safer probiotic:Frontiers in cellular and infection microbiology · 2026Article
- Antibacterial hydrogels for skin infected wounds: frontier approaches as antibiotic alternatives therapy.Frontiers in cellular and infection microbiology · 2026Review
- Targeting vaginal dysbiosis: prospects for the application of live biotherapeutics products.Frontiers in microbiology · 2026Review
- Gut microbiota dysbiosis in sepsis: mechanisms and the gut-organ axis with a focus on lung and brain interactions.Frontiers in microbiology · 2026Review
- Gut-microbiota-mediated host immune modulation: mechanisms, pathological dysbiosis, and therapeutic frontiers.Frontiers in cellular and infection microbiology · 2026Review
- Beyond conventional therapies: Gut microbiota modulation and macromolecular drugs in the battle against cardiometabolic diseases.Journal of pharmaceutical analysis · 2026Review
- CRISPR-engineered microbiome: living therapeutics revolutionize blood cancer immunotherapy.NPJ biofilms and microbiomes · 2025Review
- Genome-scale metabolic model-guided systematic framework for designing customized live biotherapeutic products.NPJ systems biology and applications · 2025Review
- Regulatory framework and challenges for live biotherapeutic products in Taiwan.Journal of food and drug analysis · 2025Review
- Preclinical Assessment of Living Therapeutic Materials: State-of-Art and Challenges.ACS biomaterials science & engineering · 2025Review
- Article
- The regulatory framework for microbiome-based therapies: insights into European regulatory developments.NPJ biofilms and microbiomes · 2025Review
- A designed synthetic microbiota provides insight to community function in Clostridioides difficile resistance.Cell host & microbe · 2025Article
2 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
31 authors at 12 institutions in 7 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Recent developments in the understanding of the relationship between the microbiota and its host have provided evidence regarding the therapeutic potential of selected microorganisms to prevent or treat disease. According to Directive 2001/83/EC, in the European Union (EU), any product intended to prevent or treat disease is defined as a medicinal product and requires a marketing authorization by competent authorities prior to commercialization. Even if the pharmaceutical regulatory framework is harmonized at the EU level, obtaining marketing authorisations for medicinal products remains very challenging for Live Biotherapeutic Products (LBPs). Compared to other medicinal products currently on the market, safety assessment of LBPs represents a real challenge because of their specific characteristics and mode of action. Indeed, LBPs are not intended to reach the systemic circulation targeting distant organs, tissues, or receptors, but rather exert their effect through direct interactions with the complex native microbiota and/or the modulation of complex host-microbiota relation, indirectly leading to distant biological effects within the host. Hence, developers must rely on a thorough risk analysis, and pharmaceutical guidelines for other biological products should be taken into account in order to design relevant non-clinical and clinical development programmes. Here we aim at providing a roadmap for a risk analysis that takes into account the specificities of LBPs. We describe the different risks associated with these products and their interactions with the patient. Then, from that risk assessment, we propose solutions to design non-clinical programmes and First in Human (FIH) early clinical trials appropriate to assess LBP safety.
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.