Clinical trial · European journal of pediatrics · 2014

Rice protein formula for infants with cow's milk allergy

What it found

Infants with confirmed cow's milk protein allergy tolerated a new extensively hydrolyzed rice protein formula, and their symptoms and growth improved over 6 months.

The trial was in 40 infants.

What they found

Studies in people

Tolerance

All 40 infants tolerated the formula. None dropped out because they could not tolerate it.

Symptom score

The symptom score dropped significantly after the first month and stayed lower at 3 and 6 months.

Stools and crying

After one month, 52.6% of infants had normal stools, up from 5.3% at the start. No infant cried more than 3 hours a day, compared with 57.9% before.

Growth

Weight-for-age, weight-for-length, and BMI scores were low at the start but improved and reached normal ranges within 6 months.

Adverse events

Five serious adverse events occurred, but none were related to the formula. One non-serious event, food refusal, was related and led to a patient leaving the study.

Taste

81.2% of parents reported that their infants liked the taste of the formula.

What the authors conclude

“In accordance with current guidelines, this eRHF was tolerated by more than 90 % of children with proven CMPA with a 95 % confidence interval.”
Vandenplas Y, De Greef E, Hauser B, Paradice Study Group, 2014

Also in their conclusions

  • They conclude that the formula was tolerated by more than 90% of infants with proven cow's milk protein allergy.
  • They say it is an adequate and safe alternative to cow milk based extensively hydrolyzed formula.
  • They call for more studies with more subjects on safety, growth, and development.

How it was done

Guidelines recommend extensively hydrolyzed cow's milk formulas for infants with cow's milk protein allergy, but these are expensive and often taste bitter. The authors wanted to see if a rice protein based formula could be a good alternative.

They fed 40 infants with confirmed cow's milk protein allergy a new extensively hydrolyzed rice protein formula for 6 months. They tracked symptoms with a score and monitored weight and length.

What it can’t tell you

  • This trial was open label, so parents and doctors knew which formula was given, which could affect how symptoms were reported.
  • The trial did not compare the rice formula with a cow's milk based formula, so it cannot show whether one works better than the other.
  • The study lasted only 6 months, so longer term effects are not known.

The paper

Title
Safety and tolerance of a new extensively hydrolyzed rice protein-based formula in the management of infants with cow's milk protein allergy
Type
Clinical trial
Evidence
Studies in people
Summarised from
Full text
Cite
Vandenplas Y, De Greef E, Hauser B, Paradice Study Group (2014). Safety and tolerance of a new extensively hydrolyzed rice protein-based formula in the management of infants with cow's milk protein allergy. European journal of pediatrics. doi:10.1007/s00431-014-2308-4Free full textPubMed 24723091DOI

Summary written 26 Sep 2026. Check it against the paper before it changes what you eat. How we summarise papers · Report an error