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The SPADE Study: New Clinical Trial Finds Early Milk Introduction Key to Preventing Milk Allergy

The breakthrough SPADE study shows that feeding cow's milk-based formula to babies ages 1-2 months can help reduce a baby's milk allergy risk by up to 88%. We cover everything families need to know about the new SPADE study.

Milk allergy is the most common food allergy among young children. It's also one of the allergies with the greatest impact on quality of life, since so many foods contain milk.

 

Fortunately, new evidence from the SPADE (Strategy for Prevention of Milk Allergy by Daily Ingestion of Infant Formula in Early Infancy) clinical trial shows that milk allergies can be prevented.

The SPADE study's results show that introducing cow's milk-based formula to babies early and often can help prevent them from developing a milk allergy. Here's what parents need to know about the SPADE study and early milk introduction. 

The SPADE Study: Overview 

In the SPADE study, infants either consumed cow's milk-based formula daily between one and two months of age, or avoided cow's milk-based formula during that same period. The goal of the SPADE study was to see if early, consistent introduction of formula made from cow's milk would help protect babies from developing a cow's milk allergy in the future.

We've broken down everything parents need to know about the SPADE study in the table below.

What were the goals of the SPADE study? To see if early, consistent introduction of cow's milk-based formula (CMF) would help prevent babies from developing a cow's milk allergy.

Also, to see if introducing cow's milk-based formula for possible milk allergy prevention could be done without interfering with breastfeeding.
Who participated in the study?
  • 491 babies starting at age 1 month
    • Enrolled between Jan. 2017 and Aug. 2019
    • From 4 different hospitals in Japan
  • All healthy babies 
    • Babies couldn't participate if they had any complications of a severe disease
  • All with a gestational age over 35 weeks and a birth weight over 2000g (4.4lbs)
    • Babies born extremely prematurely couldn't participate
  • All from the general Japanese population 
    • Not all at high risk for milk allergy
How was the SPADE study conducted?
  • Before starting the study, babies were given an oral food challenge with cow's milk-based formula, to make sure they didn't already have a milk allergy.
  • Babies who didn't react to the food challenge were randomly assigned to either consume CMF daily, or avoid it, between 1 and 2 months of age.
  • Mothers of all babies (in both groups) continued to breastfeed throughout the study.
    • Mothers were instructed to keep consuming cow's milk while breastfeeding.
How much cow's milk-based formula was given to the "consume" group? How often? What kind?
  • Parents were asked to have their baby consume at least 10ml of CMF daily between 1-2 months of age
    • = 150mg of cow's milk protein per day
  • To be included in "consume" group results, babies were required to consume CMF for an average of 20 days/month until baby reached 3 months of age
    • No interruption in CMF feeding could be longer than one week for a baby to be included in "consume" group" results
  • No upper limit on the amount of CMF babies could consume 
  • Parents could choose the type and brand of CMF they used
What were the requirements for feeding babies in the "avoid" group?
  • Avoid CMF as much as possible 
    • Avoid feeding baby CMF for at least 20 days/month between 1 and 2 months of age 
    • Parents were encouraged to use a soy-based formula to supplement breastfeeding when needed, but didn't have to use the soy formula as long as they avoided CMF
How did researchers check to see if babies developed a cow's milk allergy?
  • Skin-prick tests
  • An oral food challenge at 3 months of age
    • Babies were gradually given doses of CMF that together equaled 50ml
    • Doctors closely monitored the babies to see if they developed an allergic reaction
  • A second oral food challenge at 6 months of age
    • Babies were gradually given doses of CMF that together equaled 100ml
    • Doctors closely monitored the babies to see if they developed an allergic reaction
What percentage of families followed the study protocol in each group?
  • "Consume" group: 89.9% of participants' families followed the protocol (fed CMF 20 or more days/month).
  • "Avoid" group: 83.0% of participants' families followed the protocol (avoided CMF 20 or more days/month).
What did the SPADE study's results show?

Consuming cow's milk-based baby formula consistently between 1-2 months of age reduced babies' risk of developing a milk allergy by 87.9%.

  • 6.8% of the babies in the "avoid" group (17 out of 249) developed a cow's milk allergy 
  • Meanwhile, only 0.8% of the babies in the "consume" group (2 out of 242) developed a cow's milk allergy 

In addition, the daily CMF introduction didn't interfere with breastfeeding. 


The SPADE Study: Breaking Down the Findings

The SPADE study showed that consistently introducing cow's milk-based formula to babies between 1 and 2 months of age reduces their milk allergy risk.

  • 6.8% of the babies in the "avoid" group (17 out of 249) developed a cow's milk allergy.
  • Meanwhile, only 0.8% of the babies in the "consume" group (2 out of 242) developed a cow's milk allergy. 

So, early, consistent CMF introduction reduced babies' milk allergy risk by 88%.

Early, consistent CMF introduction reduced babies' milk allergy risk by 88%.

In fact, none of the babies who fully followed the daily CMF regimen, and consumed at least 70ml of CMF per week (10ml of CMF per day), developed a milk allergy. So, daily CMF feedings of at least 10ml per day are especially protective against cow's milk allergy.

Out of the babies in the "consume" group who fully followed the recommended daily CMF regimen (10ml every day), none developed a cow's milk allergy.

Interestingly, significantly more babies in the "consume" group  than in the "avoid" group kept consuming CMF daily between 3 and 5 months of age (54.2% in the "consume" group  vs 35.0%  in the "avoid" group). This longer sustained exposure may reduce babies' risk for developing a milk allergy even further, based on results from the previous EAT study.

The SPADE study also shows that early cow's milk introduction is safe and doesn't often result in severe allergic reactions. As the study report states, "no CMF-related adverse events occurred during the study."

The SPADE study shows that early cow's milk introduction is safe: "no CMF-related adverse events occurred during the study."

CMF introduction also doesn't interfere with breastfeeding, according to SPADE. 70% of the babies in the study were still being breastfed at 6 months of age.

Life After the SPADE Study: What do the findings mean for your family?

The SPADE study shows that early, consistent introduction of cow's milk can help protect your baby from developing a milk allergy. Here’s what parents should take away from the SPADE study:

  • Starting at 1-2 months old, feeding your baby cow's milk-based formula daily can help protect them from developing a cow's milk allergy.
    • Feeding cow's milk consistently is key to prevention!
  • If you choose to breastfeed, keep breastfeeding your baby when feeding them the formula. Rest assured that the formula feeding won't interfere with your breastfeeding. 
  • We already know from the EAT study that consistently introducing cow's milk starting around 3 months of age has a protective effect against milk allergies. SPADE now shows that starting cow's milk introduction even earlier than that is also beneficial.  

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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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