Probiotics and the Microbiome—How Can We Help Patients Make Sense of Probiotics?
Abstract
The notion of probiotics as microbes that confer health benefits has its origins in the speculative ideas that are more than a century old, yet remain largely unsubstantiated by scientific evidence. The recent advances in microbiome science have highlighted the importance of intestinal microbes in human physiology and disease pathogenesis. These developments have provided a boost to the probiotics industry, which continues to experience exponential growth driven mainly by creative marketing. Consumers, patients, and most health care providers are not able to discern the underlying science or differentiate the permitted claims that promise vague health benefits from disease-specific claims reserved for drugs. No probiotic product has been able to satisfy the regulatory requirements to be categorized as a drug, a substance intended to cure, mitigate, or prevent disease. However, patients take probiotic products in the belief that they will help to treat their intestinal or systemic diseases. Thus far, the regulators have failed to create policies that would assist to inform the public in this area. In fact, the existing regulatory regime actually creates formidable barriers to research that could provide evidence for clinical efficacy of probiotic products. We propose a potential solution to this vexing problem, where a committee created through a partnership of academia, professional organizations, and industry, but free of potential conflicts of interest, would be charged with rigorous evaluation of specific probiotic products and the evidence in support of their different claims. Companies that would submit to this process would earn the trust of consumers and healthcare providers, as well as a distinction in the marketplace.
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The properties and potential benefits of probiotics are dependent on the used dosage and cannot be extrapolated from one microbial strain to another, even if both are part of the same species.
“The FAO/WHO Expert Consultation concluded that the properties and potential benefits of probiotics are dependent on the used dosage and cannot be extrapolated from one microbial strain to another, even if both are part of the same species [14].”
From The Potential Impact of Probiotics on Human Health: An Update on Their Health-Promoting Properties (2024) · cites this paper as [14]
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- Authors
- Britton, R. A., Hoffmann, D. E., & Khoruts, A.
- Affiliations
- Baylor College of Medicine (US)
- University of Maryland, Baltimore (US)
- University of Minnesota (US)
- Corresponding author
- Khoruts, Alexander
- Venue
- Gastroenterology
- Publisher
- Elsevier BV
- Published
- 2021-01
- Volume
- 160
- Issue
- 2
- Pages
- 614-623
- ISSN
- 0016-5085 (ISSN-L)
- OpenAlex
- W3113109983
- Cited by
- 40
- References
- 33
- Citations by year
- 2026: 4 · 2025: 14 · 2024: 7 · 2023: 5 · 2022: 5 · 2021: 4 · 2020: 1
- FWCI
- 2.43
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Gastroenterology (publishedVersion)
- PubMed (publishedVersion)
- Funders
- BioGaia
- Topics
- Life Sciences › Agricultural and Biological Sciences › Food Science › Probiotics and Fermented Foods
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Gut microbiota and health
- Health Sciences › Medicine › Complementary and alternative medicine › Complementary and Alternative Medicine Studies
- Keywords
- probiotics, gut microbiota, probiotic regulation, health claims, consumer health information, regulatory policy, conflicts of interest
- MeSH terms
- Gastrointestinal Microbiome, Drug Industry, Humans, Legislation, Drug, Dietary Supplements, Probiotics, Biomedical Research
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