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Computer-generated representation of the microbiome
Photo: Oleksandra Troian / Getty Images
Commercial intestinal bacteria tests for consumers are apparently often not very informative.
US scientists warn that claims by companies that they are able to detect abnormal microbiomes are not supported by research.
Instead, consumers could be exploited or even harmed, writes the group led by Diane Hoffmann from the University of Maryland in Baltimore in the journal “Science”.
Microbiome tests are also offered in Germany.
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“There is currently no consensus about what constitutes a healthy composition of the human microbiome in a population or population group,” emphasize Hoffmann and colleagues.
In recent decades, science has discovered that the composition of intestinal bacteria is important for a person's health.
However, a healthy intestinal microbiome can look different in different people.
In recent years, an industry has emerged that offers testing and analysis to consumers using stool samples and completed questionnaires, similar to genetic testing.
Microbiome tests also evaluate the genetic material present in the sample to determine the types and frequencies of bacteria and other living beings in the intestine.
Sales pitch for vitamin pills
During their research, the authors found 31 commercial providers worldwide.
"Approximately 45 percent of the companies we identified sell dietary supplements that they recommend to consumers based on their test results," writes Hoffmann's group.
She therefore fears commercial exploitation of consumers.
The authors' main criticism in "Science" is that companies do not have to prove the analytical and clinical significance or clinical benefit of their tests.
They refer to an unpublished study by the US National Institute for Standards and Technology (NIST).
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NIST sent seven microbiome testing companies each three samples from a standardized source of stool material - so the samples were all the same composition.
Significant differences in results occurred not only in the reports of different companies, but even in the three reports of the same companies.
Hoffmann and colleagues discussed the topic with a working group of microbiome researchers, clinicians, medical device legal experts, industry and consumer representatives, and bioethicists.
Based on the assessments and their own research, they recommend greater regulation of microbiome tests by US authorities, possibly even classifying them as medical devices, which would mean stricter regulations.
"Although our recommendations target the U.S. regulatory system, they may also apply to other countries where these services are marketed," the group writes in the Science article.
yes/dpa