Probiotic human study design and reporting (PRODARE): Recommendations to improve research practice

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dc.contributor.authorSzajewska, Hania
dc.contributor.authorBenninga, Marc
dc.contributor.authorChatonidi, Georgia
dc.contributor.authorCostabile, Adele
dc.contributor.authorLane, Jonathan
dc.contributor.authorvan Loo-Bouwman, Carolien A.
dc.contributor.authorMersh, Cath
dc.contributor.authorMorales, Patricia Sanz
dc.contributor.authorWalton, Gemma
dc.contributor.authorCollado, Maria Carmen
dc.contributor.authorFrancavilla, Ruggiero
dc.contributor.authorFulling, Christine
dc.contributor.authorHolbech Jensen, Benjamin Anderschou
dc.contributor.authorPascual, David Perez
dc.contributor.authorRoss, Paul R.
dc.contributor.authorvan den Akker, Chris H.P.
dc.contributor.authorVandenplas, Yvan
dc.contributor.authorVidra, Nikoletta
dc.contributor.authorOuwehand, Arthur C.
dc.date.accessioned2026-10-13T13:36:01Z
dc.date.available2026-10-13T13:36:01Z
dc.date.issued2026-01-01
dc.description.abstractThe 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.en
dc.description.sponsorshipInternational Life Sciences Institute (ILSI) Europe
dc.description.versionPublished Version
dc.format.extent12
dc.format.mimetypeapplication/pdfen
dc.identifier.articleid100668
dc.identifier.authororcidSzajewska, Hania
dc.identifier.authororcidBenninga, Marc
dc.identifier.authororcidChatonidi, Georgia
dc.identifier.authororcidCostabile, Adele
dc.identifier.authororcidLane, Jonathan
dc.identifier.authororcidvan Loo-Bouwman, Carolien A.
dc.identifier.authororcidMersh, Cath
dc.identifier.authororcidMorales, Patricia Sanz
dc.identifier.authororcidWalton, Gemma
dc.identifier.authororcidCollado, Maria Carmen
dc.identifier.authororcidFrancavilla, Ruggiero
dc.identifier.authororcidFulling, Christine
dc.identifier.authororcidHolbech Jensen, Benjamin Anderschou
dc.identifier.authororcidPascual, David Perez
dc.identifier.authororcidRoss, Paul R.§0000-0003-4876-8839
dc.identifier.authororcidvan den Akker, Chris H.P.
dc.identifier.authororcidVandenplas, Yvan
dc.identifier.authororcidVidra, Nikoletta
dc.identifier.authororcidOuwehand, Arthur C.
dc.identifier.citationSzajewska, H, Benninga, M, Chatonidi, G, Costabile, A, Lane, J, van Loo-Bouwman, C A, Mersh, C, Morales, P S, Walton, G, Collado, M C, Francavilla, R, Fulling, C, Holbech Jensen, B A, Pascual, D P, Ross, P R, van den Akker, C H P, Vandenplas, Y, Vidra, N & Ouwehand, A C 2026, 'Probiotic human study design and reporting (PRODARE): Recommendations to improve research practice', Advances in Nutrition, vol. 17, no. 8, 100668, pp. 1-12. https://doi.org/10.1016/j.advnut.2026.100668
dc.identifier.doi10.1016/j.advnut.2026.100668
dc.identifier.endpage12
dc.identifier.issn2161-8313
dc.identifier.issued8
dc.identifier.journaltitleAdvances in Nutrition
dc.identifier.startpage1
dc.identifier.urihttps://hdl.handle.net/10468/19436
dc.identifier.volume17
dc.language.isoen
dc.publisherElsevier B.V.
dc.relation.urihttps://www.scopus.com/pages/publications/105042591077
dc.rights© 2026, authors. Published by Elsevier Inc. on behalf of American Society for Nutrition. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/)
dc.rights.accessrightsopen access
dc.rights.licensenameAttribution 4.0 International
dc.rights.urihttps://creativecommons.org/licenses/by/4.0/
dc.statusPeer reviewed
dc.subjectExploratory studies
dc.subjectHuman study design
dc.subjectObservational cohort studies
dc.subjectPilot studies
dc.subjectProbiotics
dc.subjectRandomized controlled trials
dc.subjectReal-world studies
dc.subjectRecommendations
dc.subject[APCMicrobiome]
dc.subject[Microbiology]
dc.titleProbiotic human study design and reporting (PRODARE): Recommendations to improve research practiceen
dc.typeArticle (peer-reviewed)
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