At home, microbiome testing is underregulated, unreliable and likely a waste of money, according to a scathing report issued today by researchers from the University of Maryland and the US National Institute of Health.
The report reviewed 31 testing companies that offer the tool online – costing up to $500 – which promises to examine the variety and amount of bacteria in the gut, vagina and skin and use that information to provide answers about their health.
The tests analyze fecal samples as well as skin and vaginal swabs to produce an online report on a customer’s microbiome and whether they could benefit from a pre- or probiotic.
Some companies claim that their tests will provide answers to persistent acne; ‘take the guesswork out of it with our easy, at-home skin microbiome test kit’, while others say they can help you identify exactly which supplements will help your gut.
There are hundreds of gut bacteria tests on the market, all of which claim to be able to provide answers about our health. But a scathing new report says many are misleading customers.
But according to the damning new report, these promises are not ‘based on scientific accuracy’ or ‘medically relevant’.
‘At these prices, the authors of the studies wrote that ‘consumers may be financially exploited’ and accused some companies of ‘deliberately misleading consumers’.
Our gut bacteria have long been said to play a critical role in determining a number of health outcomes by releasing chemical signals to other parts of the body.
Studies have implicated the intestinal flora in our risk of a wide range of diseases – from diabetes to depression.
Recently, researchers have suggested that the collection of microscopic insects in other parts of the body – such as the vagina and skin – can also indicate signs of poor health and explain problems such as acne and infections.
But the results of the latest study prompted the researchers to call on US regulators to step in and add stricter requirements to the tests.
“Many of their marketing claims imply, and may lead consumers to believe, that the results are based on scientific accuracy and are medically relevant when this has not been substantiated,” read the report, published in journal Science.
In addition to reviewing the validity of available tests, researchers from the University of Maryland interviewed doctors who treat people with intestinal and vaginal disorders, microbiome researchers and potential customers.
Studies have suggested that the quantity and quality of our microbiome can help determine our risk for a wide range of diseases – from depression to asthma
The report concludes that tests are not only a waste of money, they can actually be harmful to those with serious conditions such as Crohn’s disease and irritable bowel syndrome who may use the tests in the belief that they might help their symptoms.
“Many individuals who seek these tests have serious chronic illnesses and are desperate to try anything that can relieve their pain and suffering,” said Dr. Jacques Ravel, professor of immunology at the University of Maryland and co-author of the paper.
He added that patients mistakenly believe that taking a supplement recommended by the testing companies could cure their ailments.
About 45 percent of the 31 companies they identified that sell these tests also have their own custom brand of supplements that are recommended to patients.
The report also cast doubt on the benefits of dietary supplements that claim to improve health by altering the microbiome.
The authors say that research into the microbiome is so new and frequently changing, which means there is not yet a clear scientific definition of what a healthy microbiome looks like.
The tests work by analyzing the various samples for bacterial DNA. They determine which bacteria are present and at what level based on the genetic material.
Generally, these companies determine whether your biome is healthy or not by comparing it to the microbiome of someone with a chronic disease. If it looks similar, you are considered unhealthy.
But this doesn’t actually mean what the companies claim, because “there is no consensus on what constitutes a healthy human microbiome composition in any population.”
In addition, the report found serious discrepancies in the laboratories. When they sent the same sample to the same lab multiple times, it gave different results.
Diane Hoffman, a lawyer involved in the research, wrote that the FDA must investigate the validity of these tests and their marketing claims.
If they’re going to be used as diagnostics, like COVID-19 tests, then they need to be more strictly regulated by the FDA and have to report on their performance, Hoffman said.
This must be done ‘before any of these companies can claim a relationship between a test result and a person’s health, or if dietary changes and supplements can improve the microbiome and someone’s health,’ she wrote.