Rice protein formula and growth in infants with cow's milk allergy
What it found
Infants with cow's milk protein allergy who were fed a hydrolysed rice formula grew normally over 12 months, with no meaningful difference from those fed a hydrolysed milk formula.
The study was in 105 infants.
What they found
Studies in people
Growth
Weight-for-length improved over the study in both groups, and there was no significant difference between the rice formula and milk formula groups. Other body measurements also showed normal growth with no significant differences between groups.
Tolerance to cow's milk
At the end of 12 months, 72.2% of infants in the rice formula group and 53.7% in the milk formula group had acquired tolerance to cow's milk protein, with no significant difference between groups. The median age at tolerance acquisition was 16.3 months in the rice formula group and 20.4 months in the milk formula group, also not significantly different.
Digestive tolerance
There were no differences between groups in regurgitations or colic at any time point. Both decreased over the follow-up period.
Arsenic levels
Arsenic concentrations were low in both groups. Hair arsenic was below 0.07 mg/kg in all samples, and urine arsenic was similar between groups.
Adverse events
The number of adverse events was similar between groups. One infant in the milk formula group had an allergic reaction to the product, while no infant in the rice formula group did. None of the serious adverse events were considered related to the study treatment.
What the authors conclude
“This study confirms that HRF can be used with confidence as a first-line alternative to cow's milk for feeding infants with CMPA, resulting in normal growth, the acquisition of tolerance and no clinically relevant safety issues.”
Also in their conclusions
- They conclude that HRF can be used with confidence as a first-line alternative to cow's milk for feeding infants with CMPA, resulting in normal growth, the acquisition of tolerance and no clinically relevant safety issues.
- They say this will expand management options for patients and physicians and allow parents a choice in the nutrition of their children with CMPA.
- They advise that future research should focus on larger, multicentre studies with a broader age range at enrolment, detailed data on breastfeeding and designs aimed at formally evaluating the non-inferiority of HRF in diverse CMPA populations.
How it was done
Hydrolysed rice formula is tolerated by most children with cow's milk protein allergy, but concerns have been raised that it might support poorer growth than extensively hydrolysed milk formula. The authors wanted to compare growth, safety and tolerance acquisition between the two.
They randomly assigned 105 infants under 10 months old with confirmed cow's milk protein allergy to receive either a hydrolysed rice formula or an extensively hydrolysed milk formula for 12 months. The infants were followed at six hospital paediatric clinics in Spain, France and Belgium.
What it can’t tell you
- The study was relatively small and enrolled infants at a relatively older age, so the results may not apply to all infants with cow's milk protein allergy.
- The findings only relate to the specific study products evaluated and cannot be generalised to all infant formulas on the market.
- The study did not formally test whether the rice formula was non-inferior to the milk formula, so a small difference cannot be ruled out.
Who paid
- Conflicts
- A.L.: none to declare. A.N.-G.: none to declare. M.N.-C: none to declare. B.E.-J.: has received honoraria for lectures from Alter, Mead Johnson, Ferrer, Nestle, Nutricia/Danone, Hero and Abbott and has participated in advisory boards for Mead Johnson, Nutricia/Danone, Ferrer and Abbott. Á.M.: none to declare. H.S.: is an employee of Laboratoires Modilac (France) which co-funded the study. D.S.: none to declare. N.K: study honoraria and presentation with conferences expenses from Laboratoires Modilac France, Laboratoires NIH, France, Laboratoires Nutricia, France, and Laboratoires Dr Falk, France. J.D.O.: was an employee of Laboratorios Ordesa (Spain), which co-funded the study. R.d.C.-S.: is an employee of Ordesa Laboratory (Spain), which co-funded the study. V.M.N.-L.: has received honoraria for lectures from Mead Johnson, Ferrer, Nestle, Nutricia/Danone, Hero and Abbott.
- Authors work at
- Sorbonne Université, France; Hospital Universitari y Politècnic La Fe, Spain; Hospital Infantil Virgen del Rocío, Spain
The paper
- Title
- Growth, Safety and Tolerance in Infants Fed Rice Protein Hydrolysate Formula: The GRITO Randomised Controlled Trial
- Type
- Randomised controlled trial
- Evidence
- Studies in people
- Summarised from
- Full text
- Cite
- Lemoine A, Nieto-García A, Nieto-Cid M, et al (2024). Growth, Safety and Tolerance in Infants Fed Rice Protein Hydrolysate Formula: The GRITO Randomised Controlled Trial. Nutrients. doi:10.3390/nu17010162Free full textPubMed 39796596DOI
Summary written 26 Sep 2026. Check it against the paper before it changes what you eat. How we summarise papers · Report an error