The Use of an Amino Acid Formula Containing Synbiotics in Infants with Cow's Milk Protein Allergy-Effect on Clinical Outcomes

Nutrients. 2021 Jun 27;13(7):2205. doi: 10.3390/nu13072205.


Cow's milk protein allergy (CMPA) is common and costly. Clinical trials of infants with CMPA have shown that the use of an amino acid formula containing pre- and probiotics (synbiotics) (AAF-Syn) may lead to significant reductions in infections, medication prescriptions and hospital admissions, compared to AAF without synbiotics. These effects have not yet been confirmed in real-world practice. This retrospective matched cohort study examined clinical and healthcare data from The Health Improvement Network database, from 148 infants with CMPA (54% male, mean age at diagnosis 4.69 months), prescribed either AAF-Syn (probiotic Bifidobacterium breve M16-V and prebiotics, including chicory-derived oligo-fructose and long-chain inulin) or AAF. AAF-Syn was associated with fewer symptoms (-37%, p < 0.001), infections (-35%, p < 0.001), medication prescriptions (-19%, p < 0.001) and healthcare contacts (-18%, p = 0.15) vs. AAF. Infants prescribed AAF-Syn had a significantly higher probability of achieving asymptomatic management without hypoallergenic formula (HAF) (adjusted HR 3.70, 95% CI 1.97-6.95, p < 0.001), with a shorter clinical course of symptoms (median time to asymptomatic management without HAF 1.35 years vs. 1.95 years). AAF-Syn was associated with potential cost-savings of £452.18 per infant over the clinical course of symptoms. These findings may be attributable to the effect of the specific synbiotic on the gut microbiome. Further research is warranted to explore this. This real-world study provides evidence consistent with clinical trials that AAF-Syn may produce clinical and healthcare benefits with potential economic impact.

Keywords: amino acid formula; cow’s milk protein allergy; dietetics; infections; paediatrics; synbiotics.

MeSH terms

  • Amino Acids*
  • Animals
  • Cattle
  • Dietetics
  • Female
  • Gastrointestinal Microbiome
  • Humans
  • Infant
  • Infant Formula / chemistry*
  • Male
  • Milk Hypersensitivity*
  • Probiotics
  • Retrospective Studies
  • Synbiotics*


  • Amino Acids