Evidence map›Paper›PMID 40011030›Full record

ArticleGut2025

Development of live biotherapeutic products: a position statement of Asia-Pacific Microbiota Consortium.

Ching-Hung Tseng, Sunny Wong, Jun Yu, Yeong Yeh Lee, Jun Terauchi, Hsin-Chih Lai, Jiing-Chyuan Luo, Cheng Yen Kao, Sung-Liang Yu, Jyh-Ming Liou and 7 more

Abstract readConsensus Statement
In one paragraph

Article in Gut, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

21 citing papers in PubMed.

  1. Review
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  5. Gut microbiota in health and disease.Molecular biomedicine · 2026
    Review
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  7. Article
  8. Review
  9. Review
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  11. Review
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  14. Review
  15. Towards a safer probiotic:Frontiers in cellular and infection microbiology · 2026
    Article
  16. Review
  17. Review
  18. Review
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  20. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors.

Ching-Hung TsengGermark Biotechnology, Co, Ltd, Taichung, Taiwan.ORCID http://orcid.org/0000-0002-6026-9015
Sunny WongLee Kong Chian School of Medicine, Nanyang Technological University, Singapore.ORCID http://orcid.org/0000-0002-3354-9310
Jun YuDepartment of Medicine and Therapeutics, Institute of Digestive Disease, and The State Key Laboratory of Digestive Disease, The Chinese University of Hong Kong, Hong Kong, SAR, China.ORCID http://orcid.org/0000-0001-5008-2153
Yeong Yeh LeeSchool of Medical Sciences, Universiti Sains Malaysia, Kota Bharu, Kelantan, Malaysia.ORCID http://orcid.org/0000-0002-6486-7717
Jun TerauchiJapan Microbiome Consortium (JMBC), Osaka, Japan.
Hsin-Chih LaiDepartment of Medical Biotechnology and Laboratory Science, College of Medicine, Chang Gung University, Kwei-Shan, Taiwan.
Jiing-Chyuan LuoDivision of Gastroenterology and Hepatology, Department of Medicine, Taipei Veterans General Hospital, Taipei, Taiwan.
Cheng Yen KaoInstitute of Microbiology and Immunology, National Yang Ming Chiao Tung University, Taipei, Taiwan.
Sung-Liang YuDepartment of Clinical Laboratory Sciences and Medical Biotechnology, College of Medicine, National Taiwan University, Taipei, Taiwan.
Jyh-Ming LiouDepartment of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan.ORCID http://orcid.org/0000-0002-7945-5408
Deng-Chyang WuDivision of Gastroenterology, Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung, Taiwan.
Ming-Chih HouDivision of Gastroenterology and Hepatology, Department of Medicine, Taipei Veterans General Hospital, Taipei, Taiwan.ORCID http://orcid.org/0000-0002-4886-0718
Ming-Shiang WuDepartment of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan.
Jiunn-Jong WuDepartment of Medical Laboratory Science and Biotechnology, Asia University, Taichung, Taiwan.
Joseph J Y Sung *Lee Kong Chian School of Medicine, Nanyang Technological University, Singapore dr.wu.taiwan@gmail.com e.el-omar@unsw.edu.au josephsung@ntu.edu.sg.ORCID http://orcid.org/0000-0003-3125-5199
Emad M El-OmarUNSW Microbiome Research Centre, University of New South Wales, Sydney, New South Wales, Australia dr.wu.taiwan@gmail.com e.el-omar@unsw.edu.au josephsung@ntu.edu.sg.ORCID http://orcid.org/0000-0002-0011-3924
Chun-Ying Wu *Microbiota Research Center, Health Innovation Center, and Institute of Biomedical Informatics, National Yang Ming Chiao Tung University, Taipei, Taiwan dr.wu.taiwan@gmail.com e.el-omar@unsw.edu.au josephsung@ntu.edu.sg.ORCID http://orcid.org/0000-0001-5053-1801

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveLive biotherapeutic products (LBPs) are biological products composed of living micro-organisms, developed to prevent, treat, or cure diseases. Examples include cultured strains of

designExperts in microbiome research, microbiology, gastroenterology, internal medicine and biotherapeutics industry were invited to form a panel. During the 2023 Inauguration Conference of the Asia-Pacific Microbiota Consortium, an organised, iterative roundtable discussion was conducted to build expert consensus on critical issues surrounding the development of LBP.

resultsThe consensus statements were organised into three main aspects: (a) rationales of LBP development, (b) preclinical studies and (c) preparation for clinical studies. The panel strongly recommended to prioritise human-derived and food-sourced strains for development, with indications based on clinical need and efficacy shown in studies. Preclinical evaluation should involve thorough screening, genotyping and phenotyping, as well as comprehensive in vitro and animal studies to assess functional mechanisms and microbiological safety. Rigorous cell banking practices and genetic monitoring are essential to ensure product consistency and safety throughout the manufacturing process. Clinical trials, including postmarketing surveillance, must be carefully designed and closely monitored, with robust safety and risk management protocols in place.

conclusionsThe development of LBP should be approached with a strong emphasis on microbiological evaluation, clinical relevance, scientific mechanisms and safety at every stage. These measures are essential to ensure the safety, effectiveness and long-term success of the product.

Indexed as

Biological ProductsGastrointestinal MicrobiomeMicrobiotaProbioticsAsiaHumansBiological ProductsENTERIC BACTERIAL MICROFLORAMICROBIOMEPROBIOTICS

Identifiers

PMID40011030
PMCPMC12013581

What OpenQuestion holds

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Registered trials

None linked

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.