D3.274 - Feasibility of Digestive Enzyme Supplementation for Cow’s Milk Allergy in Exclusively Breastfed Infants

Cow’s Milk Allergy (CMA) affects approximately 2.4% of UK infants. In breastfed babies, trace cow’s milk (CM) proteins from maternal diets can trigger non-IgE mediated allergic symptoms, occasionally requiring complete maternal CM exclusion. Maternal CM exclusion is challenging and may lead to early cessation of breastfeeding. Protease supplementation has been shown to reduce transfer of egg protein from maternal diet to breast milk. Use of digestive enzyme mixtures such as pancreatin, which contains protease in addition to lipase, could enable maternal CM consumption without infant symptoms. We undertook a feasibility study to evaluate the acceptability of digestive enzyme use in mothers and infants with non-IgE mediated CMA.

Eligible participants were full-term, exclusively breastfed infants (<12 months) with confirmed non-IgE mediated CMA. Following a 3-day maternal CM reintroduction challenge, symptomatic infants (CoMiSS>=12) were enrolled into an 8-week cross-over intervention: mothers ingested pancreatin (Creon 10,000 Abbot Laboratories, Germany) enzyme capsules for 4 weeks, then infants received pancreatin powder (Pancrex V, Lelypharma, The Netherlands) for 4 weeks (or vice versa). Infant symptoms, growth, and skin condition were monitored using a novel parent reported outcome measure; maternal wellbeing was assessed via questionnaires.

Of 60 infants screened in secondary care, 48 had already stopped breastfeeding due to concerns about CMA. Twelve met enrolment criteria 2 withdrew and 10 went on to CM challenge. Six infants had CoMiSS<12 after maternal CM reintroduction and did not proceed to the enzyme trial. Four infants were enrolled; two withdrew for unrelated reasons, and two completed the protocol. Both mothers maintained breastfeeding consuming CM daily. Mean CoMiSS reduced from 13.5 to 3.5 on infant Pancrex V and 0.5 on maternal Creon. Both mothers chose to continue enzyme use post-study.

Digestive enzyme supplementation appears feasible and acceptable for managing non-IgE mediated CMA in breastfed infants. Infants demonstrated symptom improvement supporting breastfeeding in CMA. Recruitment challenges highlight the need for earlier intervention in infants with suspected CMA. The findings demonstrate support progression to a larger, controlled trial to evaluate efficacy and long-term outcomes for both infant and breast-feeding mother.