Transition Of Hypoallergenic Amino Acid Formulas During the Infant Formula Shortage: Impact On Clinical Outcomes

Cekola P., Boccella J., Desai A., et al.
JPGN 2023;77(1): A 761, S552-553

Background:

In February 2022, Abbott Nutrition issued a voluntary recall of their powdered infant formulas, which led to formula shortages in which children with specialized nutritional needs required alternative formulas, including amino acid-based formulas (AAF).¹

AAF are hypoallergenic nutritionally complete formulas that are recommended for children with cow's milk protein allergy, children with multiple food allergies or those who experience an anaphylactic reaction to a food protein. AAF with medium chain triglycerides (MCT) are also recommended for infants with fat malabsorption or maldigestion.

Objective:

This study compared gastrointestinal (GI) and allergy symptoms in children before and after switching between two AAF during the formula shortage.

Study design:

A retrospective study using nationally representative US claims data obtained from the Decision Resources Group Real World Evidence Data Repository (Clarivate), which covers 98% of US health plans, including medical and pharmacy claims. Patient characteristics, comorbidities, and clinical outcomes were assessed in children ≤ 18 years; with a history of receiving EleCare® or EleCare® Jr formulas (AAAF, Abbott Nutrition, US) and having switched to Alfamino® Infant or Alfamino® Junior formulas (NAAF, Nestlé HealthCare Nutrition, US); in postacute care settings between June 2021 and April 2023.

Methods:

The index date was defined as the date when patients switched from AAAF to NAAF. The pre-switch period was defined as 6 months prior to the index date. Post-switch periods were 1 month, 3 months and 6 months after the index date. GI intolerance and allergy symptoms at pre- and post-switch periods were compared using a Chi-square test.

Results:

402 patients aged 0-18 years from all US regions; mean (standard deviation [SD]) age was 5.3 (4.7) years. Most common comorbidities pre-switch were GI conditions (51%), congenital conditions (49%) and developmental delays (27%). In 355 patients (88%) with ≥1 comorbidity, the mean (SD) pediatric comorbidity index (PCI) score was 4.8(3.4).

Significantly fewer children experienced any GI intolerance symptoms at 1 month, 3 months and 6 months post-switch (AAAF to NAAF), compared with pre-switch (p< 0.001). Significant reductions in percent of children reporting abdominal distention, diarrhea, flatulence, and nausea & vomiting were observed at all time-periods post-switch compared with pre-switch (p<0.05). Figure 1

At 1 month, 3 months and 6 months post-switch, significantly fewer patients experienced any allergy symptoms compared with pre-switch (p<0.05). Allergies in the categories of hives and other allergic reactions showed significant reductions only at 1 month post-switch. Table 2

Conclusion:

This study found that children in post-acute care settings successfully transitioned from AAAF (Elecare® ) to NAAF (Alfamino®) Infant or Junior products with significantly fewer reported allergy symptoms and GI intolerance symptoms, including abdominal distention, constipation, diarrhea, flatulence, and nausea & vomiting up to 6 months post-formula switch.

During the nationwide powdered formula shortage, children who transitioned from AAAF to NAAF, showed significantly fewer GI intolerance and allergy symptoms. These findings suggest potential clinical benefits with a change from AAAF to NAAF.

References: 
(1) The White House. 2022. FACT SHEET: President Biden Announces Additional Steps to Address Infant Formula Shortage. May 12, 2022; <https://www.whitehouse.gov/briefing-room/statements-releases/2022/05/12/fact-sheet-president-biden-announces-additional-steps-to-address-infant-formula-shortage;
(2) Cekola P et al. (2023) NASPGHAN. Oct 4-7;77(1), S552

Study summary prepared by Nestlé Healthcare Nutrition. Download PDF of Summary

The poster presented at NASPGHAN 2023 may be accessed online: NASPGHAN Abstract 761

The complete abstract may be accessed online: NASPGHAN 2023.pdf (lww.com)

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