Synbiotic containing extensively hydrolyzed formula improves gastrointestinal and atopic symptom severity, growth, caregiver quality of life, and hospital-related healthcare use in infants with cow's milk allergy

Immun Inflamm Dis. 2022 Jun;10(6):e636. doi: 10.1002/iid3.636.


Background: Healthy gut microbiota is important for prognosis in cow's milk allergy (CMA). The application of synbiotics (specific pre- and probiotics) in extensively hydrolyzed formulae (eHFs) is a relatively new concept.

Aims: To evaluate a synbiotic-containing, whey-based eHF (SeHF) with galacto-oligosaccharides, fructo-oligosaccharides, and bifidobacterium breve M-16V in infants with CMA.

Materials and methods: A 31-day one-arm pilot study in 29 infants with CMA (mean age 30.8 weeks [SD 11]) was undertaken, with outcomes including gastrointestinal tolerance, atopic dermatitis symptoms, dietary intake, growth, SeHF acceptability, caregiver quality of life, and hospital-related healthcare use.

Results: Significant improvements (p < .05) in the severity of abdominal pain (in 57%), burping (in 46%), flatulence (in 79%), constipation (in 14%), rhinitis (41%), and itchy eyes (73%), as well as atopic dermatitis in those with severe baseline symptoms (PO-SCORAD© reduction: 34.7-18.2 (p = .003), n = 6) were observed over time. Growth and caregiver quality of life scores significantly increased (+26.7%, p < .05) over time. Hospital visits and medications significantly reduced (-1.61 and -2.23, respectively, p < .005) in the 6 months after SeHF initiation.

Discussion: In this small, single-arm, pilot study, the use of SeHF enhanced the management of infants with non-IgE mediated CMA who were already established on eHF.

Conclusion: Whilst this study adds to the evidence base for the use of SeHF in CMA, further robust research to explore the longer-term benefits of synbiotics, specifically the blend used in this study, for the clinical management of infants with CMA is warranted.

Keywords: cow's milk allergy; dermatitis; prebiotics; probiotics; synbiotics.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Animals
  • Caregivers
  • Cattle
  • Delivery of Health Care
  • Dermatitis, Atopic*
  • Female
  • Hospitals
  • Humans
  • Milk Hypersensitivity* / therapy
  • Oligosaccharides
  • Pilot Projects
  • Quality of Life
  • Synbiotics*


  • Oligosaccharides