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12th Dec, 2025 12:00 AM
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Synbiotic Formula May Benefit Infants With Milk Allergy

TOPLINE:

An extensively hydrolyzed formula with a synbiotic alleviated or resolved symptoms in more than 85% of infants with presumed cow’s milk protein allergy (CMPA) within 4 weeks. Parents reported high acceptability of the formula and a significant improvement in their quality of life.

METHODOLOGY:

  • Researchers conducted an observational study in France from June 2021 to April 2023, analyzing 80 infants aged 8 months or younger with presumed immunoglobulin E (IgE)-mediated or non-IgE-mediated CMPA.
  • All participants received an extensively hydrolyzed formula with a synbiotic containing galacto-oligosaccharide, fructo-oligosaccharide, and Bifidobacterium breve M-16V.
  • Primary outcomes were changes in general condition and symptoms assessed using a four-level Likert scale (worse/identical/improved [or alleviated]/resolved) at the 28-day follow-up.
  • Researchers assessed parents’ quality of life using the Family Quality of Life-Parental Burden (FAQL‐PB) score, where higher scores indicated greater parental burden.

TAKEAWAY:

  • The general condition improved or resolved in 86.3% (95% CI, 78.7%-93.8%) of participants at week 28.
  • Overall, digestive, cutaneous, and respiratory symptoms resolved or were alleviated in 93.2% (95% CI, 87.5%-99.0%), 68.4% (95% CI, 53.6%-83.2%) and 62.5% (95% CI, 38.8%-86.2%) of participants, respectively.
  • The formula was deemed suitable by 78.8% of parents.
  • At week 28, a significant decrease in the FAQL‐PB score from baseline was observed (P < .001).

IN PRACTICE:

“For clinical practice, this study emphasizes the need to wait at least 2 weeks before changing the formula or reassessing the diagnosis,” the authors of the study wrote. 

SOURCE:

Anaïs Lemoine, MD, with the Sorbonne Université, Paris, France, was the corresponding author of the study, which was published online on December 5 in the Journal of Pediatric Gastroenterology and Nutrition.

LIMITATIONS:

This study was limited by its single‑arm, uncontrolled design and short follow-up duration. The confirmation of CMPA was limited by subjective symptoms and the absence of early challenge testing. Concomitant symptomatic treatments were not recorded and may have affected symptom-related outcomes.

DISCLOSURES:

This study was funded by Nutricia. Several authors reported receiving grants or contracts; consultancy fees; payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events; and support for attending meetings and/or travel from the funding company and other healthcare companies.

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This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.


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