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

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Publicado en:PLoS One vol. 20, no. 7 (Jul 2025), p. e0321543
Autor principal: Mills, Kate
Otros Autores: Tan, Joelle, Guneratne, Tahlia, Lindsay Keir, Goldstein, Maya, Ventola, Cécile, Makama, Maureen, Ammerdorffer, Anne, Gülmezoglu, A Metin, Vogel, Joshua P, McDougall, Annie R A
Publicado:
Public Library of Science
Materias:
Databases
Pathogens
Womens health
Probiotics
Feedback
Premature birth
Content analysis
Pregnancy
Dietary supplements
Research & development > R&D
Candidates
Drug development
Interviews
Microbiomes
Intestinal microflora
Gut microbiota
Effectiveness
Criteria
Variables
Surveys
Drug delivery
Stakeholders
Preeclampsia
Product development
Social
Acceso en línea:Citation/Abstract
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Resumen: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.
ISSN:1932-6203
DOI:10.1371/journal.pone.0321543
Fuente:Health & Medical Collection