Details including experts involved of
each activity
Task Force Information
Objectives
Consumers, the scientific community, regulators and the food and dietary supplement industry show increasing interest in probiotics and their health benefits. The attention of the task force is thus focused on the understanding of the role of probiotics in health and disease, their mechanisms of action while increasing awareness of their direct/indirect benefits on health.
Task Force Members
Arthur Ouwehand – Chair
International Flavors & Fragrances (IFF)
R&D Group Manager
FI
Geertrui Vlaemynck* – Co-Chair
Institute for Agricultural and Fisheries Research (ILVO)
For more detailed information, please contact Maria Tonti at mtonti@ilsieurope.be
Activity Overview
Ongoing Activities
- Probiotic Clinical Study Design
The Expert Group will work on recommendations and a decision tree for designing effective probiotic clinical studies. This initiative will bring together experts from academia, industry, and regulatory bodies to enhance research quality by establishing reporting guidelines, streamlining study design, and developing reliable protocols tailored to the unique nature of live microbes.
The activity will involve a workshop on the 3rd of April 2025, at ILSI Europe office in Brussels. More info for the workshop to be announced soon.
Start date: Q4 2024 - End date: Q2 2025
- Markers of the Gut Microbiota
The group aims to identify key markers for assessing microbiota improvement, focusing on measurable indicators of microbiota composition and activity that are relevant to human health. This activity will address the need for standardized markers to evaluate dietary interventions, combining various indicators for comprehensive evaluation. The activity is shared with the Prebiotics Task Force.
Start date: Q1 2025 - End date: Q2 2026
Upcoming Activities
- Postbiotics for early life nutrition
The Expert group aims to explore the emerging role of postbiotics in infant nutrition through a focused, workshop-style debate involving experts in microbiota, pediatrics, and nutritional science. This initiative will identify key challenges, assess knowledge gaps, and develop recommendations to guide future research and applications. The outcomes will be published to support evidence-based guidance in infant and early childhood health. This is a joint activity with the Early Nutrition and Long-Term Health Task Force.
Start date: Q4 2025 - End date: Q2 2027
Expert Groups
Probiotic Clinical Study Design
Background and Objectives
The aim of this activity is to develop recommendations and a decision tree for designing effective probiotic clinical studies, taking into account the unique characteristics of live microbes. This initiative will gather input from experts in academia, CROs, industry, and regulatory bodies to enhance the quality and outcomes of probiotic research. The objectives include: (1) organizing a consensus workshop to establish proper reporting guidelines, (2) generating a decision tree to streamline study design, and (3) recommending study protocols that ensure control and reliability. The activity will also focus on identifying appropriate study designs for various research purposes and highlighting critical considerations specific to probiotics, including the importance of accurate study reporting.
Output
This activity will result in recommendations/ decision tree to optimize study design, taking into account the unique, live nature of probiotics.
The PRObiotic human study Design And REporting recommendations provide a structured framework for designing and reporting human studies with probiotics, addressing challenges related to product viability.
This perspective examines how pregnancy-related microbial shifts, both natural andprobiotic-induced, affect maternal and fetal health and highlights potential opportunities for theinnovative use of probiotics during the gestation period
We provide a detailed review unfolding how the physiological and anatomical differences between the small and large intestine affect gut microbiota composition, function, and plasticity. This information is key to understanding how gut microbiota manipulation, including probiotic administration, may strain-dependently transform host-microbe interactions at defined locations.
The PRObiotic human study Design And REporting recommendations provide a structured framework for designing and reporting human studies with probiotics, addressing challenges related to product viability. Five main study types are identified. Exploratory studies are early-phase, first-in-human investigations designed to evaluate effects or generate hypotheses and require specification of strain, dose, stability, and assessment of acceptance and adverse events. Pilot studies assess the feasibility of protocols and logistics before larger trials, with clearly defined objectives, compliance measures, and data management plans. Randomized controlled trials represent the reference standard for evaluating efficacy and safety and include the use of core outcome sets, blinding procedures, and adherence monitoring. Real-world studies evaluate effectiveness outside controlled research settings and require detailed protocols, comprehensive data capture, and predefined approaches for handling inconsistencies. Observational cohort studies examine associations between probiotic exposure and outcomes over time, with clearly defined endpoints, cohort selection criteria, and analysis plans. Across all study types, probiotic-specific considerations include strain characterization and sequencing, verification of identity, purity, viability, antimicrobial resistance, minimization of confounding factors, management of cross-contamination, and consistency of dosage. These recommendations aim to enhance study quality and reporting and to guide researchers in selecting study designs appropriate to their objectives.
Pregnancy induces notable alterations in the gut, vaginal, and oral microbiota driven by hormonal,immune, metabolic, dietary, and environmental factors. During pregnancy, the gut microbiota ischaracterized by increased proportions of the genus Bifidobacterium and the phylaPseudomonadota (formerly Proteobacteria) and Actinomycetota (formerly Actinobacteria). Thesechanges occur alongside reduced alpha diversity and greater beta diversity, changes that influencematernal metabolism and fetal development. Shifts in gut and oral microbiota have been asso-ciated with complications such as preterm birth (PTB), pre-eclampsia, and gestational diabetes(GDM), though patterns are sometimes inconsistent. The vaginal microbiota remains Lactobacillus-dominant during pregnancy, with reduced diversity leading to reduced risk of pathogenic infectionand increased diversity has been linked with a higher risk of PTB. Hormonal changes also affect theoral microbiota, potentially increasing pathogenic species and contributing to adverse outcomeslike PTB. Probiotic supplementation during pregnancy has significant potential to reduce adversepregnancy outcomes; however, clinical studies are still limited. Probiotics may be effective inalleviating maternal constipation and lead to lower PTB risk, particularly by modulating the vaginalmicrobiota, but they have limited impact on GDM. In the context of maternal mental health, somestudies suggest benefits of probiotics in reducing anxiety, but effects on depression are incon-clusive. This perspective examines how pregnancy-related microbial shifts, both natural andprobiotic-induced, affect maternal and fetal health and highlights potential opportunities for theinnovative use of probiotics during the gestation period.
Research on gut microbiota has generally focused on fecal samples, representing luminal content of the large intestine. However, nutrient uptake is restricted to the small intestine. Abundant immune cell populations at this anatomical site combined with diminished mucus secretion and looser junctions (partly to allow for more efficient fluid and nutrient absorption) also results in intimate host-microbe interactions despite more rapid transit. It is thus crucial to dissect key differences in both ecology and physiology between small and large intestine to better leverage the immense potential of human gut microbiota imprinting, including probiotic engraftment at biological sensible niches. Here, we provide a detailed review unfolding how the physiological and anatomical differences between the small and large intestine affect gut microbiota composition, function, and plasticity. This information is key to understanding how gut microbiota manipulation, including probiotic administration, may strain-dependently transform host-microbe interactions at defined locations.
This review focusses its narrative on the intimate relationship between the host and its bacterial constituents of the small and large intestine.
Humans often show variable responses to dietary, prebiotic, and probiotic interventions. Emerging evidence indicates that the gut microbiota is a key determinant for this population heterogeneity. Here, we provide an overview of some of the major computational and experimental tools being applied to critical questions of microbiota-mediated personalized nutrition and health. First, we discuss the latest advances in in silico modeling of the microbiota-nutrition-health axis, including the application of statistical, mechanistic, and hybrid artificial intelligence models. Second, we address high-throughput in vitro techniques for assessing inter-individual heterogeneity, from ex vivo batch culturing of stool and continuous culturing in anaerobic bioreactors, to more sophisticated organ-on-a-chip models that integrate both host and microbial compartments. Third, we explore in vivo approaches for better understanding personalized, microbiota-mediated responses to diet, prebiotics, and probiotics, from non-human animal models and human observational studies, to human feeding trials and crossover interventions. We highlight examples of existing, consumer-facing precision nutrition platforms that are currently leveraging the gut microbiota. Furthermore, we discuss how the integration of a broader set of the tools and techniques described in this piece can generate the data necessary to support a greater diversity of precision nutrition strategies. Finally, we present a vision of a precision nutrition and healthcare future, which leverages the gut microbiota to design effective, individual-specific interventions.
The scientific understanding of prebiotic and probiotic mechanisms has grown substantially in recent years. Although effects are often strain and product specific, some prebiotic and probiotic benefits may be driven by common, shared mechanisms and may therefore be generalizable. The use of emerging physiological and analytical tools in a multidisciplinary research setting will enable the elucidation of further mechanisms. In this way, it will be possible to improve the understanding of prebiotic, probiotic and synbiotic health effects. Based on recent sound scientific evidence, the monograph is a valuable reference work, aimed at informing a wide audience about the intestinal microbiota and the prebiotic and probiotic nutritional concepts.
The PRObiotic human study Design And REporting recommendations provide a structured framework for designing and reporting human studies with probiotics, addressing challenges related to product viability. Five main study types are identified. Exploratory studies are early-phase, first-in-human investigations designed to evaluate effects or generate hypotheses and require specification of strain, dose, stability, and assessment of acceptance and adverse events. Pilot studies assess the feasibility of protocols and logistics before larger trials, with clearly defined objectives, compliance measures, and data management plans. Randomized controlled trials represent the reference standard for evaluating efficacy and safety and include the use of core outcome sets, blinding procedures, and adherence monitoring. Real-world studies evaluate effectiveness outside controlled research settings and require detailed protocols, comprehensive data capture, and predefined approaches for handling inconsistencies. Observational cohort studies examine associations between probiotic exposure and outcomes over time, with clearly defined endpoints, cohort selection criteria, and analysis plans. Across all study types, probiotic-specific considerations include strain characterization and sequencing, verification of identity, purity, viability, antimicrobial resistance, minimization of confounding factors, management of cross-contamination, and consistency of dosage. These recommendations aim to enhance study quality and reporting and to guide researchers in selecting study designs appropriate to their objectives.
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