AUSTIN, Texas — When gut health comes to mind, we think only of metabolism and food digestion, but its impact goes far beyond those functions as it plays a vital role in our immune system. Several things can go wrong in the body that likely link back to the gut, such as immune disorders. But with effective wellness tests, you can better care for your gut health and get it back on track.

For a long time, health care professionals administered gut tests meant for adults on kids, despite the fact that they naturally have stark differences in the makeup of their gut microbiome — microorganisms, including bacteria, archaea, fungi and viruses that live in the digestive tracts. Tiny Health, a gut health testing company, has put its first-ever at-home microbiome gut test for infants, toddlers and expecting mothers on the market. Founder and mother of two Cheryl Sew Hoy, 39, noticed the need through her children, who motivated her to create a test parents can easily use at home to oversee and enhance their babies’ gut health development, starting at conception. 

In a Tiny Health news release, microbiology experts at universities report, “More than 40% of American school-aged children have at least one chronic disease, and this number may be higher when it comes to babies and toddlers. Eighty percent of the human immune system is in the gut and is programmed in the first 1,000 days of a person’s life, [so] researchers are turning toward early microbiome development for answers.”

Sew Hoy’s mission was to give parents a head start in preventing gut imbalances in their babies’ critical first 1,000 days of gut development, during which eczema, allergies, asthma, obesity and other chronic diseases may form. With the help of science and medical advisers, along with the support from her family, including her husband Jason Sew Hoy and mom Audrey Chan, she had the means to create a thoughtful product that could help many parents going through what she, too, experienced.

Cheryl Sew Hoy working alongside her fulfillment associates, mother Audrey Chan and Cary Buerkle, with her husband Jason Sew Hoy tending to his own business. (Spectrum News 1/Antoinette Odom)

As a serial entrepreneur and mom, Sew Hoy said, “I have a very supportive husband, and he’s an entrepreneur as well, so he understands what it takes and all that, so we support each other that way. And my mom came over to help, too. So, I would say definitely, a lot of family support is crucial in kind of like having two really young companies and two young kids, so to speak. But then, you know, being a mom and creating this company for other parents, you really do understand what they’re going through.”

When Sew Hoy became pregnant with her son Taylor in 2020, she wanted to do things differently than with her firstborn, Charlize, as it was an intrusive pregnancy she later learned was not the healthiest option for the baby. In 2018, after doctors told her that her daughter was breeched, meaning she was in a bottom-down position in the womb, she had to come to terms with having a C-section. But first, she had questions.

After doing her own research into gut health and babies, Sew Hoy discovered just how impactful that procedure could be for her child. “It’s all about the gut. She’s not passing my birth canal, like the vaginal microbiome, and she’s just being taken out of my womb… So, the part I learned was that the baby’s first sterile in the womb. They may have some microbes that come through the placenta, but [it’s] very little,” she explained. “When the water releases or breaks, that’s when the baby gets inoculated with the mom’s vaginal microbes first. And then when you’re pushing the baby out, some fecal fluid comes out. Sounds gross, but it’s actually really helpful for the baby. And that’s how the baby first gets flushed with microbes… But when that happens, usually, they inherit the microbes from the mom…” It brings up the fact as to why most cesarean babies have a higher risk of post-health challenges, and in Sew Hoy’s case Charlize was diagnosed with mild eczema and an allergy to sesame seeds associated with the early disruption to the gut. Doctors told her that her daughter could have asthma by the time she reaches age 5 or 6, but Sew Hoy was determined to figure out how to restore her gut health to eliminate that possibility.

From research and her advisers as an aid, Sew Hoy found out that if your baby exhibits allergies, then their immune system wasn’t set up correctly, which could increase the likelihood of other chronic diseases in their adult life as their gut becomes more complex in its makeup. “For babies, I realized science is so clear because when you talk about food influencing the gut, the only food a baby takes is breast milk, or supposed to be breast milk. So, their gut is really simple. It should be really simple. So, in fact, formula feeding — although some people definitely do need it because some people really can’t breastfeed for medical conditions — but we see formula prematurely accelerating maturation of the gut,” noted Sew Hoy. “So, we see higher diversity in the gut before it’s supposed to. And this causes issues because a baby’s gut is immature. There’s no immune system and they’re being trained by these microbes, these bacteria. So, if the maturation is a little bit higher, then they may kind of trigger immune conditions.”

Sew Hoy tried vaginal swabbing, homemade kefir, or fermented milk, extended breastfeeding and probiotics. But she had no way of knowing if these measures were repairing her daughter's gut. Subsequently, she researched gut tests that were on the market then to tailor one specifically for moms-to-be and those looking to conceive. 

While pregnant with Taylor during the COVID lockdown, Sew Hoy went to work getting Tiny Health off the ground, self-funding the company at the start, and eventually raising $4.5 million. “When I was pregnant with my son, I was like, this time I really want to measure his gut. I just wouldn’t take ‘no’ for an answer, for there not being a gut test in the market. I’m like a firm believer in that this is so important for their health, I want to know. So, I created a gut test and the company one month after he was born, my second child. So, I would say they are fundamental to my company,” she said.

In the beginning, Sew Hoy recruited nine moms, all pregnant at the time, to measure their gut microbiome at certain intervals every couple of months and see if conditions developed in their kids. Not being a microbiology expert, she educated herself through online Ph.D.-level courses and learned of the latest technologies to best execute a gut health test. Later in its developmental stage, she brought in Ph.D. professors Ruben Mars, Noel Mueller, Meghan Azad and other medical professionals for their expertise on the subject. An official release reads that Tiny Health has gathered “over 3,000 baby samples to inform reference ranges and condition biomarkers. Other existing stool tests use adult reference ranges, which paint quite a different picture when used on babies and young children. As Tiny Health grows, their sample base grows with it. The company is striving to assemble the largest repository of early-life microbiome data, highlighting the connection between mothers’ and babies’ microbiome health.” Through this data, evidence-based recommendations could be drawn up to present personalized information for each user, such as foods they could add to their diet, or types of probiotic they could take.

The Tiny Health gut microbiome at-home testing kit. (Spectrum News 1/Antoinette Odom)

Sew Hoy said, “Our ambition is much larger than just a test. We want to do research in the future and create therapeutics potentially that could really save babies’ lives or maybe treat certain conditions. So, that’s kind of the longer term vision of the company.” Right now, education is the primary focus for her and the team. She understands this information is fairly new to the majority, so she wants to do her part in making sure families are just as aware as she is now about their baby’s gut health to reduce or reverse any future health risks. “The company processes all tests in a CLIA-certified lab with state-of-the-art shotgun metagenomics sequencing technology, which is a huge advancement from the PCR-based gut tests normally prescribed at a physician’s office. Using this technology, Tiny Health is able to provide strain-level precision and a comprehensive list of all gut and vaginal microbes including bacteria, fungi, parasites, viruses, and archaea, and their relative abundance, which can help scientists better understand their role in a healthy body. Every report includes a personalized review by a team of microbiome experts, and evidence-based recommendations on how parents can improve the gut health of their children, as well as optimize their own for the benefit of their family,” according to a news release.

Understanding that genetics, too, is a big part in a baby’s development, Sew Hoy stressed that there are many other factors at hand in the immune system. “So, I do think that there still needs [to be] some educational components. It’s not something that’ll be at a Target or a CVS shelf, yet. But I do think maybe in three years, if anything, I think it would be at a doctor’s office. But what I learned through my research is that it takes 15 years for groundbreaking research in universities to get to the doctor’s office. It’s just a slow process for doctors to adopt it. It’s a very conservative, you know, risk-averse industry — understandably… I think, right now, we already have physicians adopting our tests, but they’re more like the functional medicine, holistic practitioners, integrative medicine…,” she said. This wellness test is for parents who are more interested in digging deeper to discover if the right kind of bacteria is being passed on to their child as their gut evolves. And in doing so, it empowers them to make choices that are more beneficial to their baby’s early immune development and overall health, so medication isn’t the end-all-be-all.

“We realized that parents, especially with babies with eczema, you know, they get prescribed steroids and creams, but it’s kind of a Band-Aid and they want to fix things from the root cause. ‘What’s underlying? What’s causing this?’ And we’re not saying that we can give them the causal answers because in microbiome everything is an association. You know, we can’t prove causation… But parents want deeper answers. So, they’re coming to us and finding us for answers,” Sew Hoy said. She explained, with those answers, parents then go to doctors that offer preventative perspectives through nutrition advice, to find out what foods are being consumed before and after the baby’s birth that could positively or negatively impact their health.

A Tiny Health timeline graphic of early microbiome development. (Tiny Health)

Tiny Health is not an FDA approved medical product, such as a diagnostic test. “It’s not that we don’t want to seek FDA approval… Gut microbiome science has really emerged in the past 10 years and in the past two to five years, it’s really accelerated — especially in infant microbiome. So, it’s relatively new in that sense.”

TheVentureCity, a global early stage venture fund investing in product-centric startups across the U.S., Europe and Latin America, is leading the round in valuating Tiny Health’s capital. “Tiny Health is the first-ever startup to develop a gut test specifically for expecting parents and infants,” said Laura González-Estéfani, founder and CEO of TheVentureCity. “We see it as an untapped niche with great potential for growth in a $12.5 billion market that will flourish over the next few years. Tiny’s consumer platform is also in a unique position to generate potentially groundbreaking research on infants’ microbiomes, which could contribute to better prediction, prevention and treatment down the line.”

To watch a demonstration of the Tiny Health testing kit, click the video above.