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自2000年以来,以益生菌为指标的临床研究作为全球增值的一种体现。

Clinical research with probiotics as an indicator of global valorization since the year 2000.

作者信息

Wiegers Cato, van Beek Eveline H T, Larsen Olaf F A

机构信息

Athena Institute, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.

出版信息

Front Microbiol. 2023 Dec 14;14:1323920. doi: 10.3389/fmicb.2023.1323920. eCollection 2023.


DOI:10.3389/fmicb.2023.1323920
PMID:38163072
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10756236/
Abstract

Probiotics are becoming increasingly popular due to their potential health benefits. With this rise in popularity and demand as indicated by ever-growing market prospects, it seems evident that innovation and valorization are on the rise as well. However, an increasing body of literature shows that innovation is stagnating, which may be detrimental to the exploitation of the benefits of probiotics, for example the development of alternative therapies to manage the increasing prevalence of metabolic and autoimmune disorders. To this end, this study investigated global clinical trials that have been executed since the year 2000 as a first indicator of the status of probiotic valorization. The cumulative number of clinical trials has indeed increased significantly from 0 at the start of the century up to 2,517 registered trials in 2023. However, in Asia, Europe, and North America, the continents with the highest numbers of clinical trials, stagnating or declining trends have been found. In these locations, most clinical trials were funded by non-industry sponsors and targeting probiotic supplements or undefined products. Considering the overall stagnation in clinical trials and viewing these trends in the context of developments in local markets and regulations, the global valorization of probiotics appears to slow down. This could impact the transition from academic research to the development of products that are beneficial and accessible for consumers, either to maintain a healthy lifestyle or to treat medical conditions.

摘要

由于益生菌具有潜在的健康益处,它们正变得越来越受欢迎。随着市场前景不断增长所表明的其受欢迎程度和需求的上升,创新和增值似乎也在增加。然而,越来越多的文献表明创新正在停滞,这可能不利于益生菌益处的利用,例如开发替代疗法来应对代谢和自身免疫性疾病患病率不断上升的情况。为此,本研究调查了自2000年以来开展的全球临床试验,作为益生菌增值状况的首个指标。临床试验的累计数量确实从本世纪初的0显著增加到2023年登记的2517项试验。然而,在临床试验数量最多的亚洲、欧洲和北美,已发现停滞或下降趋势。在这些地区,大多数临床试验由非行业赞助商资助,并且针对益生菌补充剂或未明确的产品。考虑到临床试验的总体停滞,并结合当地市场和法规的发展情况来看这些趋势,益生菌的全球增值似乎正在放缓。这可能会影响从学术研究到开发对消费者有益且可及的产品的转变,无论是为了维持健康的生活方式还是治疗疾病。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2d3f/10756236/01a0911582b5/fmicb-14-1323920-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2d3f/10756236/7174da84de3a/fmicb-14-1323920-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2d3f/10756236/4a694e841500/fmicb-14-1323920-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2d3f/10756236/84328dba50d9/fmicb-14-1323920-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2d3f/10756236/01a0911582b5/fmicb-14-1323920-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2d3f/10756236/7174da84de3a/fmicb-14-1323920-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2d3f/10756236/4a694e841500/fmicb-14-1323920-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2d3f/10756236/84328dba50d9/fmicb-14-1323920-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2d3f/10756236/01a0911582b5/fmicb-14-1323920-g004.jpg

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本文引用的文献

[1]
Probiotics, their prophylactic and therapeutic applications in human health development: A review of the literature.

Heliyon. 2022-6-22

[2]
The Gut Microbiota: Master of Puppets Connecting the Epidemiology of Infectious, Autoimmune, and Metabolic Disease.

Front Microbiol. 2022-4-29

[3]
Clinical Trials of Probiotics in Patients With Irritable Bowel Syndrome: Some Points to Consider.

J Neurogastroenterol Motil. 2022-4-30

[4]
Probiotic triangle of success; strain production, clinical studies and product development.

FEMS Microbiol Lett. 2020-10-21

[5]
On the importance of intraindividual variation in nutritional research.

Benef Microbes. 2020-10-12

[6]
Live biotherapeutic products: the importance of a defined regulatory framework.

Exp Mol Med. 2020-9

[7]
Global analysis of clinical trials with probiotics.

Heliyon. 2020-7-17

[8]
Intake of ω-6 Polyunsaturated Fatty Acid-Rich Vegetable Oils and Risk of Lifestyle Diseases.

Adv Nutr. 2020-11-16

[9]
The Effects of Probiotics and Prebiotics on Mental Disorders: A Review on Depression, Anxiety, Alzheimer, and Autism Spectrum Disorders.

Curr Pharm Biotechnol. 2020

[10]
The Microbiome and Irritable Bowel Syndrome - A Review on the Pathophysiology, Current Research and Future Therapy.

Front Microbiol. 2019-6-10

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