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

Abstract

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.

Molecular Mechanism and Clinical Effects of Probiotics in the Management of Cow’s Milk Protein Allergy

“…The study group, compared to the control group, had statistically significant improvement in clinical symptoms (−37%, p < 0.001), infections (−35%, p < 0.001), and medication effectiveness (−19%, p < 0.001), and significantly less allergic symptoms (32% vs. 61% overall, p < 0.001). Infants receiving symbiotics had a significantly higher probability of achieving asymptomatic management without hypoallergenic formula ( p < 0.001), with a shorter clinical course of symptoms [ 124 ].…”

Tolerance development in cow's milk‐allergic children receiving amino acid‐based formula with synbiotics: 36‐Months follow‐up of a randomized controlled trial (PRESTO Study)

“…Amino acid‐based formulas (AAF) with a specific blend of prebiotics and probiotics (synbiotics) are used in the dietary management of cow's milk allergy (CMA). These formulas are proven to be well‐tolerated and safe, are effective in symptom resolution and are associated with an improved gut microbiota composition and fewer (severe) infections 1–5 . We recently published the results of the randomized double‐blind controlled PRESTO study indicating that the development of tolerance to cow's milk (CM) was similar between infants with confirmed immunoglobulin E (IgE)‐mediated CMA receiving an AAF with synbiotics and those receiving an AAF without synbiotics.…”

“…These formulas are proven to be well-tolerated and safe, are effective in symptom resolution and are associated with an improved gut microbiota composition and fewer (severe) infections. [1][2][3][4][5] We recently published the results of the randomized double-blind controlled PRESTO study indicating that the development of tolerance to cow's milk (CM) was similar between infants with confirmed immunoglobulin E (IgE)-mediated CMA receiving an AAF with synbiotics and those receiving an AAF without synbiotics. The rates of acquired tolerance to CM were similar to rates observed in previous randomized dietary intervention studies in infants with IgE-mediated CMA receiving extensively hydrolysed formula and in line with natural outgrowth.…”

New Insights in Cow’s Milk and Allergy: Is the Gut Microbiota the Missing Link?

“…The effectiveness of AAF-Sym compared to AAF includes a half rate of infants experiencing allergic symptoms (−48%) and a 37% reduction in the rate of symptoms per person-year. HAF is estimated to account for up to 38% of the healthcare costs of managing CMPA in the first year after diagnosis so the findings may have a major impact, not only on infants and their families, but also on the healthcare system [6].…”