Treating cow's milk protein allergy: a double-blind randomized trial comparing two extensively hydrolysed formulas with probiotics

Acta Paediatr. 2013 Oct;102(10):990-8. doi: 10.1111/apa.12349. Epub 2013 Aug 5.


Aim: The treatment for cow's milk protein allergy (CMPA) is a diet with an extensive hydrolysate. This study aimed to determine whether a whey (eWH) or casein hydrolysate (eCH) is the best option.

Methods: Infants with suspected CMPA were treated with an eWH or eCH, and efficacy was assessed with a symptom-based score developed by the authors. Diagnosis of CMPA was based on a positive challenge. If positive, the same eHF/eCH was continued. If negative, a standard starter and follow-up formula were given up to the age of 12 months.

Results: An open challenge was performed on 85/116 (73%) infants suspected of CMPA on clinical grounds and was positive in 59/85 (69%). After 1 month, the symptom-based scores in both groups showed significant statistical and clinical reductions, and total and specific IgE and skin prick test results were similar. Both hydrolysates were enriched with probiotics, which were recovered in the gastrointestinal flora. The eWH-Standard Formula sequence led to better growth at the age of 1 year than the other three feeding regimens tested.

Conclusion: The eWH and eCH are equally effective. The symptom-based score is a useful tool to evaluate the efficacy of dietary treatment in infants with CMPA.

Trial registration: NCT01727115.

Keywords: (extensive) Hydrolysate; Cow's milk protein allergy; Infant nutrition; Probiotic.

Publication types

  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Caseins*
  • Double-Blind Method
  • Female
  • Follow-Up Studies
  • Humans
  • Infant
  • Infant Formula*
  • Logistic Models
  • Male
  • Milk Hypersensitivity / diagnosis
  • Milk Hypersensitivity / diet therapy*
  • Milk Proteins* / adverse effects
  • Probiotics / therapeutic use*
  • Protein Hydrolysates / therapeutic use*
  • Treatment Outcome
  • Whey Proteins


  • Caseins
  • Milk Proteins
  • Protein Hydrolysates
  • Whey Proteins

Associated data