Efficacy and Tolerance of a New Anti-Regurgitation Formula

Christophe Dupont1, Yvan Vandenplas2,

  • 1Department of Paediatric Gastroenterology Hepatology and Nutrition, Hôpital Necker Enfants Malades, Paris, France.

Insights

A new anti-regurgitation (AR) infant formula, thickened with a novel fiber complex, significantly reduced daily regurgitation episodes. This AR formula demonstrated effectiveness without negatively impacting infant stool consistency or frequency.

Area of Science:

  • Pediatrics
  • Infant Nutrition
  • Gastroenterology

Background:

  • Infant regurgitation is a common physiological issue.
  • Existing anti-regurgitation (AR) formulas may require further optimization.
  • Novel thickening agents are being explored to improve efficacy.

Purpose of the Study:

  • To evaluate the efficacy of a new AR formula (Novalac) thickened with an innovative fiber-based complex.
  • To assess the formula's impact on the daily number of regurgitations in infants.
  • To determine the effect on stool consistency and frequency.

Main Methods:

  • A trial involving infants under five months with at least 5 regurgitations daily.
  • Assessment of regurgitation frequency, Vandenplas score, stool consistency, and frequency at 14 and 90 days.
  • Monitoring of infant growth parameters throughout the study.

Main Results:

  • Significant reduction in daily regurgitations observed within two weeks (-6.3±3.3, p<0.001).
  • Efficacy was consistent across infants, including those previously on thickened formulas.
  • Appropriate infant growth was maintained, with improved weight-for-age z-scores after 90 days.

Conclusions:

  • The novel AR formula effectively reduces infant regurgitation.
  • The innovative fiber-based thickening complex is safe and well-tolerated.
  • No adverse effects on stool consistency were noted, with most infants achieving formed or soft stools.
Abstract

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