Maternal gut microbiome interventions to improve maternal and perinatal health outcomes: Target product profile expert consensus and pipeline analysis

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Vydáno v:PLoS One vol. 20, no. 7 (Jul 2025), p. e0321543
Hlavní autor: Mills, Kate
Další autoři: Tan, Joelle, Guneratne, Tahlia, Lindsay Keir, Goldstein, Maya, Ventola, Cécile, Makama, Maureen, Ammerdorffer, Anne, Gülmezoglu, A Metin, Vogel, Joshua P, McDougall, Annie R A
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024 7 |a 10.1371/journal.pone.0321543  |2 doi 
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100 1 |a Mills, Kate 
245 1 |a Maternal gut microbiome interventions to improve maternal and perinatal health outcomes: Target product profile expert consensus and pipeline analysis 
260 |b Public Library of Science  |c Jul 2025 
513 |a Journal Article 
520 3 |a ObjectiveTo develop a novel Target Product Profile (TPP) outlining the minimum and optimal requirements of probiotics targeting the maternal gut microbiome, create a research and development (R&D) pipeline of maternal microbiome interventions, and identify the highest potential probiotic candidates matching TPP criteria.DesignA mixed-methods study including in-depth interviews, an international survey, and online public consultation, with systematic R&D pipeline development.SettingInternational research context in maternal gut microbiome interventions.PopulationTen stakeholder groups were included in the study for feedback on the TPP development.MethodsStakeholder feedback from 23 interviews and 32 survey responses was analyzed to revise the TPP. A systematic search of databases (Adis Insight, ClinicalTrials.gov, WHO ICTRP, Ovid MEDLINE, and relevant grant databases) identified drugs, supplements, and biologics targeting the maternal gut microbiome. Probiotic candidates were matched against key TPP criteria to identify promising options for future research.Main Outcome MeasuresStakeholder consensus (≥75% agreement) on TPP variables and identification of high-potential probiotic candidates.ResultsThe TPP met consensus for most of the 20 variables: 16 for minimum and 14 for optimal targets. Interviews raised issues concerning indication, target population, diagnostic requirements, and efficacy outcomes. Of 38 candidates identified in the maternal microbiome pipeline (2000–2023), eight were probiotics, with one high-potential candidate (Vivomixx) and two medium-potential candidates (Lactobacillus spp. and Bifidobacterium spp.) identified.ConclusionsThis study produced the first TPP and pipeline analysis for maternal gut microbiome interventions, identifying probiotics with higher potential. Few candidates reached late-phase research, highlighting the need for efficacy trials. 
653 |a Databases 
653 |a Pathogens 
653 |a Womens health 
653 |a Probiotics 
653 |a Feedback 
653 |a Premature birth 
653 |a Content analysis 
653 |a Pregnancy 
653 |a Dietary supplements 
653 |a Research & development--R&D 
653 |a Candidates 
653 |a Drug development 
653 |a Interviews 
653 |a Microbiomes 
653 |a Intestinal microflora 
653 |a Gut microbiota 
653 |a Effectiveness 
653 |a Criteria 
653 |a Variables 
653 |a Surveys 
653 |a Drug delivery 
653 |a Stakeholders 
653 |a Preeclampsia 
653 |a Product development 
653 |a Social 
700 1 |a Tan, Joelle 
700 1 |a Guneratne, Tahlia 
700 1 |a Lindsay Keir 
700 1 |a Goldstein, Maya 
700 1 |a Ventola, Cécile 
700 1 |a Makama, Maureen 
700 1 |a Ammerdorffer, Anne 
700 1 |a Gülmezoglu, A Metin 
700 1 |a Vogel, Joshua P 
700 1 |a McDougall, Annie R A 
773 0 |t PLoS One  |g vol. 20, no. 7 (Jul 2025), p. e0321543 
786 0 |d ProQuest  |t Health & Medical Collection 
856 4 1 |3 Citation/Abstract  |u https://www.proquest.com/docview/3226650883/abstract/embedded/75I98GEZK8WCJMPQ?source=fedsrch 
856 4 0 |3 Full Text  |u https://www.proquest.com/docview/3226650883/fulltext/embedded/75I98GEZK8WCJMPQ?source=fedsrch 
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