NOTE TO READERS: When this project lost substantial funding at the end of 2018, I lost the ability to continue publishing criteria-driven news story reviews and PR news release reviews - once the bread-and-butter of the site going back to 2006. The 3,200 archived reviews, while still educational, are getting old and difficult for me to technically maintain on the back end of the website. So I am announcing that I plan to remove these reviews from the site by April 1, 2021. The blog and the toolkit - two of the most popular features on the site - will remain. If you wish to peruse the reviews before they disappear, please do so by the end of March 2021. After that date you may still be able to access them via the Internet Archive Wayback Machine - https://archive.org/web/.
Read Original Release

Time to test all infants’ gut microbiomes — or is this a product in search of a condition?

First-Ever Rapid Response Test for Levels of Bifidobacterium in Baby's Gut Microbiome

Our Review Summary

microbiomeThis release by Evolve Biosystems, Inc. highlights a new, pen-shaped prototype that can allegedly and indirectly test baby poop for low or high levels of a beneficial gut bacteria called Bifidobacterium longum (subspecies infantis). Such microorganisms can break down indigestible molecules in a mother’s breast milk. There is also some limited evidence to suggest high levels of Bifidobacterium can improve an infant’s nutrition and health, and protect against “dangerous” bacteria in the gut that can cause issues late into life.

However, the release doesn’t explain how the test works, what its harms may or may not be, and how accurate it is or is not in showing there’s ample Bifidobacterium in a baby’s gut. The release also introduces an existing product, called Evivo probiotics, that a baby would take if a low level of Bifidobacterium was found — but does not describe the price, harms, effectiveness, and other important aspects of such a medical product.

There is no evidence provided about the test itself. Confoundingly, the release links to two studies that find correlations between Bifidobacterium levels and the incidences of certain health issues, yet states there is not yet any definitive, causal link between any of them. At best, publishing this release feels premature — more research, and a lot of it, is required. At worst, it’s a misleading and paper-thin marketing pitch to a future round of investors.

 

Why This Matters

Researchers are learning more and more about collections of microorganisms that live in the human body, called microbiomes, and their effects on our health. So far, none seem to be as large, diverse, and important to our overall health as the gut microbiome.

Babies’ gut microbiomes are a growing area of scientific interest, and specifically those of breastfed versus formula-fed babies. These studies hint at important differences that exist between the two: Breastfed babies appear to have far more Bifidobacterium, which appear to feed on indigestible sugars in breast milk. This may enhance overall nutrition for those infants. Some studies even hint that Bifidobacterium may help the gut rein in or reduce harmful microbes and lower the risk of certain diseases, perhaps even late into life.

In conjunction with such research, American use of probiotic products quadrupled from 2007 to 2012, according to NIH data, with nearly 2 million using them in 2012 (a number that is likely much higher today). But only a limited number of these products have any preliminary evidence that they work, and for a limited number of health issues. Similarly, the products of Evolve Biosystems, Inc. are built on correlations about how and when such bacteria work in the gut, and not yet any definitive causal evidence.

This is an emerging area of research and it is too early to introduce point of care tests to evaluate gut microbiomes in infants, since we are unable to know the long term clinical significance of the findings. There may be none.

Criteria

Does the news release adequately discuss the costs of the intervention?

Not Satisfactory

The only dollar sign in this release is a notation that Evolve BioSystems obtained $40 million in recent funding.

The release states the Evolve stool-testing device is a prototype, so we’ll give that a pass — it implies it can’t be purchased. But not listing the price of the Evivo probiotic, which is described later, doesn’t get a pass: The two are inextricably linked by the release, i.e. babies with low levels of Bifidobacterium would be given the probiotic.

The Evivo probiotic product ranges from $80 for a one-month supply to $335 for a six-month supply, though it is unclear how long a baby is supposed to take it.

Does the news release adequately quantify the benefits of the treatment/test/product/procedure?

Not Satisfactory

Testing a baby’s stool for Bifidobacterium is presumably beneficial, according to the release, because not having low levels may allow “for potentially harmful bacteria such as E. Coli and Clostridia to thrive, which are linked to higher risk of short- and long-term health issues such as colic, eczema, allergies, diabetes, and obesity.” Likewise, the release implies taking the Evivo probiotic product can “reduce potentially harmful bacteria by 80 percent.”

But these statements and figures are inadequate. There is not yet definitive, causal evidence that Bifidobacterium can prevent “harmful” bacteria from overtaking the gut and causing health problems. Both studies intimate as much by highlighting the findings are correlations, and that long-term longitudinal studies are required.

It’s misleading to claim a benefit from testing when there is no causal link to harm in people.

Does the news release adequately explain/quantify the harms of the intervention?

Not Satisfactory

The test itself is described as “quick and non-invasive.” However, the release transitions to the Evivo probiotic product, which is a live culture of Bifidobacterium bacteria that’s designed to augment such microbes in a baby’s gut. There are no potential harms discussed here.

However, the CDC’s website states about probiotics (generally): “In healthy people, probiotics usually have only minor side effects, if any. However, in people with underlying health problems (for example, weakened immune systems), serious complications such as infections have occasionally been reported.”

Does the news release seem to grasp the quality of the evidence?

Not Satisfactory

This release states that the Evivo stool test looks for two chemicals associated with Bifidobacterium, and that increased pH (i.e. more basic) in stools over the past century correlates with decreasing levels of such bacteria in babies’ guts. But there’s really no explanation for how the test works.

Furthermore, the release claims the Evivo probiotic product “is the only baby probiotic clinically proven to restore Bifidobacterium to a baby’s gut and reduce potentially harmful bacteria by 80 percent.” However, researchers are still trying to get a grasp on the human gut microbiome — the field is still in its early days — what differentiates a “good” from a “bad” bacteria, and under which circumstances issues arise.

But you don’t need to take our word for it. The release links to two research studies, one of which states that long-term studies “comparing the incidence of autoimmune disorders with restored Bifidobacterium populations in the infant gut microbiome are essential to establish the role of Bifidobacterium in early immune development in the infant gut.”

Does the news release commit disease-mongering?

Not Satisfactory

This release doesn’t have any scary or over-the-top wording, but it does warn parents that not treating the microbiome in infants may lead to future health problems for their child. And that suggestion is not based on research showing a causal relationship. This appears to be a product looking for a disease that does not exist, or at the very least, a condition that is poorly understood.

Does the news release identify funding sources & disclose conflicts of interest?

Satisfactory

The Evivo stool test is clearly described as owned by Evolve Biosystems, Inc., and that company’s associations and funding are similarly made clear.

Does the news release compare the new approach with existing alternatives?

Not Satisfactory

No alternatives to a test discovering low levels of Bifidobacterium are noted — that is, other than using Evivo probiotic products to raise them. One option not mentioned is to ignore the test entirely and not use any medical product like Evivo probiotics (or similar), since studies that the release links to say long-term research is required to suss out any definitive link between low or high levels of Bifidobacterium in a baby’s gut and their health later in life.

Additionally, people could avoid antibiotics (the primary cause of shifts in the microbiome) and feed their children a variety of foods which probably results in healthy colonization.

Does the news release establish the availability of the treatment/test/product/procedure?

Satisfactory

The Evivo stool test is described as a prototype, implying it’s not available on the market.

Does the news release establish the true novelty of the approach?

Not Satisfactory

The novelty is not made clear, and especially so for the stool test. A study linked to by the release also does not contain any methods — they are available only by request — making it doubly difficult to assess the novelty of the device.

Does the news release include unjustifiable, sensational language, including in the quotes of researchers?

Not Satisfactory

We saw the words “proven” and “proving” in the release, which raised some red flags. The research appears too preliminary to prove anything, especially when both studies referenced by the release contain caveats saying as much.

Total Score: 2 of 10 Satisfactory

Comments

Please note, comments are no longer published through this website. All previously made comments are still archived and available for viewing through select posts.