The Spade Study on Milk Allergy Prevention: 3 Key Takeaways for Parents

Food allergies can be dangerous to our baby’s long-term health and even life-threatening in the short-term. This can make it worrying to introduce new foods. In actuality, it’s often beneficial to introduce new foods while our children are infants. 

A new study by the Department of Pediatrics at Heartlife Hospital in Okinawa, Japan, shines a light on what we can do to prevent dairy allergies. An allergy to cow’s milk (CMA – Cow’s Milk Allergy) is one of the most common food allergies. CMA is often confused with lactose intolerance, but they are actually different conditions.

Like all allergies, the body’s immune system steps in when cow’s milk is ingested, identifying it as an intruder. This usually develops early in someone’s life. Lactose intolerance, on the other hand, doesn’t usually develop before the age of five. A difference is that this is where the body finds it difficult to digest lactose. This is fortunate, as lactose is one of the most important carbohydrates found in breast milk and is very beneficial for babies.

Let’s take a closer look at what a cow’s milk allergy (CMA) looks like in babies, at what the study set out to discover, and the 3 main takeaways you need to know as a parent. 

Cow’s Milk Allergy

CMA usually appears within the first 12 months of a baby’s life and affects around 3 percent of children. Symptoms of allergies are usually distressing, especially in infants. Symptoms of CMA in infants include: 

  • rashes 
  • hives 
  • eczema 
  • diarrhea 
  • constipation 
  • acid reflux 
  • vomiting 
  • tiredness 
  • general discomfort signs, such as crying and being unable to sleep 
  • difficulty breathing 
  • anaphylactic shock in worst cases 

Some CMA symptoms appear immediately – within 2 hours of ingestion – while others can take 2 days to appear. 

Anaphylaxis is the most severe and requires immediate treatment. Sometimes lethal, anaphylaxis narrows the airways and can prevent breathing. Cow’s milk is the third most common food trigger leading to an anaphylactic response. If your baby does become allergic to cow’s milk, you should always carry an EpiPen. 

What Were the Goals of The SPADE Study?

SPADE stands for Strategy for Prevention of milk Allergy by Daily ingestion of infant formula in Early infancy. The study set out to show that cow’s milk allergies are preventable if introduced early enough in a child’s life. 

The research, carried out between 2017 and 2019, involved comparing two groups of healthy babies from four hospitals in Japan. Starting at one-month-old, a group of 242 babies were given at least 10ml of cow’s milk formula (CMF) daily. A second group of 249 babies had their intake of CMF restricted to less than 20 days a month between the age of 1-2 months. Parents were encouraged to use a soy-based formula, if required. Both groups were encouraged to use breast milk as their main source of nutrition.

All babies were tested for CMA and given a full health check-up before starting the study. Parents were free to choose the brand of CMF. To remain a part of the study, no baby in the “consume” group could go without CMF for more than a week. Both sets of mothers were told to drink cow’s milk themselves while breastfeeding.

Babies had skin-prick tests and were given a “food challenge” at 3 and 6 months of age. This is where they consumed a total of 50ml and 100ml respectively, under the watchful eye of a doctor. Over 83 percent of participating families in each group stuck to protocol and completed the study. 

Major Findings from the SPADE Study

Regular Consumption of Cow’s Milk Between 1-2 Months Reduces Risk of CMA by 87.9 percent

The first takeaway is also the biggest one: exposure to cow’s milk early in an infant’s life reduces the likelihood of CMA significantly. Just 1% of babies in the “consume” group developed CMA. 7 percent of those in the restricted intake group developed it. That’s a 6 percent increase compared to just 2 babies in the “consume” group, and 0 babies out of those who fully completed the study. 

This significant drop in risk highlights the benefits of giving your baby CMF early in life, even while breastfeeding.

Early Introduction of Cow’s Milk Reduces the Likelihood of Severe Reactions 

As we discussed in the Cow’s Milk Allergy section at the beginning of this article, many of the symptoms of CMA can severely affect a child’s quality of life. Fortunately, these severe reactions are unlikely in young infants. In fact, despite the large (491) number of participants, the study saw no “adverse events” due to the intake of CMF. 

That shows that the earlier an infant is introduced to cow’s milk, the less likely they are to have a severe allergic reaction. Don’t allow the fear of severe symptoms to delay you from feeding your baby CMF. Just a small amount early on could help prevent this later in life. If you’re hesitant, you can always check with your baby’s pediatrician to ensure how to safely introduce cow’s milk to your baby.

Cow’s Milk Intake Can Be Minimal and Still Be Beneficial 

The babies in the study were only required to consume 10ml of cow’s milk a day. A baby drinks approximately 570-900ml a day, so even just a tiny amount of cow’s milk in their diet can be effective. 

A study by Kings College London in 2015 called the Enquiring About Tolerance (EAT) study looked at whether this method extends to other foods. The results of this study suggested that early (from 3 months) introduction of foods that often cause allergies (peanuts, shellfish, wheat, etc.) could prevent allergies from developing, but further study is needed. 

While the EAT study results were not as clear, the SPADE study clearly shows that even a 10ml dose of cow’s milk can reduce the likelihood of CMA. 

Consider introducing just 10ml of CMF into your baby’s daily diet to prevent CMA. 

What if your baby already shows signs of CMA or if they are over 2 months old? 

You can still introduce a small amount of cow’s milk into your baby’s diet at an older age. While the SPADE study showed that younger was better in this case, older infants can still benefit. If your child is older and has yet to be introduced to cow’s milk, introduce the minimum (10ml) into their diet daily and watch for adverse reactions. 

In severe cases, a cow’s milk allergies can be set off through your breastmilk. Ask your physician if it’s safe for you to continue consuming cow’s milk if your baby has CMA. Depending on your own dietary needs, you may decide to cut cow’s milk from your diet or move your baby onto a soy-based formula. 

If you believe your baby already shows signs of CMA, contact your pediatrician and ask them for advice. They will be able to do a test and determine the severity of your baby’s allergy, if they do indeed have one. 

Can parents apply SPADE principles to other foods? 

This is the question the EAT study set out to answer. So, while introducing new foods to children at a young age is generally accepted, you shouldn’t draw conclusions based on the SPADE study that apply to other allergens. Each allergy needs to be evaluated separately. 

However, there’s promising news given new USDA guidelines. This reinforces much of what’s been found in the SPADE study as well as LEAP, EAT, and PETIT.

Key Takeaways for Parents 

  • You can help reduce the likelihood of CMA in your child 
  • The earlier you introduce CMF into your child’s diet, the better (the study took babies from 1 month old) 
  • CMF intake can be as little as 10ml a day to be effective in preventing CMA 
  • Earlier is safer; early introduction may actually reduce the likelihood of severe reactions 

Given the cow’s milk allergy is one of the most common childhood food allergies, the SPADE Study on milk allergy prevention gave parents important information on how food allergies can be prevented. It doesn’t require much effort on our part, either, just a small dose of cow’s milk per day.

Let’s hope that ongoing research produces similar results for other foods that can induce severe allergic reactions, such as peanuts and shellfish. Severe allergic reactions can be life-threatening, but hopefully, future research will empower parents to do more to prevent this in the future. 


All health-related content on this website is for informational purposes only and does not create a doctor-patient relationship. Always seek the advice of your own pediatrician in connection with any questions regarding your baby’s health.

These statements have not been evaluated by the Food and Drug Administration. Products are not intended to diagnose, treat, cure or prevent any disease. 

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