2024-03-17 07:23:13
Special tests are intended to detect the microorganisms in the intestine. However, researchers are now doubting the results. And see dangers for consumers.
Since the bestseller “Intestines with Charm” we have known: The microorganisms in the intestines are important for health. If you want to test whether your own intestinal flora is intact, you can use over-the-counter tests. However, American scientists have now discovered that the tests are often not very informative.
Claims by companies that they have the ability to detect abnormal microbiomes are not supported by research. Consumers could instead be exploited and harmed, warns the group led by Diane Hoffmann from the University of Maryland in Baltimore in the journal “Science.
Healthy intestinal flora looks different for everyone
“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. A healthy intestinal microbiome can look different in different people.
The challenge with an intestinal flora test is not only to correctly detect the microorganisms, but also to draw conclusions from the test results.
Commercial interest of the test providers
During their research, the authors found 31 commercial providers worldwide that offer tests and analyzes for consumers based on stool samples and completed questionnaires. The genetic material present in the sample is evaluated to determine the types and frequencies of bacteria and other organisms in the intestine.
“Approximately 45 percent of the companies we identified sell nutritional supplements that they recommend to people based on their test results,” writes Hoffmann’s group. She therefore fears that test providers would “take advantage” of consumers.
Same sample – different test results
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 They refer to an unpublished study by the US National Institute for Standards and Technology (NIST).
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.
Stronger regulation here too?
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 products. That 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.