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Double-blind comparative trial with 2 antiregurgitation formulae

Y Vandenplas1, B Leluyer, M Cazaubiel

  • 1UZ Brussel, Vrije Universiteit Brussel, Brussels, Belgium. yvan.vandenplas@uzbrussel.be

Journal of Pediatric Gastroenterology and Nutrition
|May 8, 2013
PubMed

Insights

Two antiregurgitation formulas (ARF) effectively reduced infant regurgitation. ARF-2, containing specific whey hydrolysate, demonstrated superior efficacy in decreasing both the frequency and volume of regurgitation compared to ARF-1.

Area of Science:

  • Pediatric Gastroenterology
  • Infant Nutrition
  • Clinical Trial Research

Background:

  • Infant regurgitation is a common concern for mothers seeking medical advice.
  • Current guidelines suggest reassurance and dietary modifications as initial management strategies.
  • The study aimed to evaluate and compare two specific antiregurgitation formulas (ARF).

Purpose of the Study:

  • To assess the efficacy of two different antiregurgitation formulas (ARF) in managing infant regurgitation.
  • To compare the effectiveness of ARF-1 (nonhydrolyzed protein, locust bean gum) against ARF-2 (specific whey hydrolysate, locust bean gum, specially treated starch).

Main Methods:

  • A prospective, double-blind, randomized cross-over trial was conducted over one month.
  • 115 formula-fed infants aged 2 weeks to 5 months participated.
  • The primary outcome measured was the incidence of regurgitation.

Main Results:

  • Both ARF significantly reduced the mean number of regurgitation episodes.
  • ARF-2 showed a statistically significant greater reduction in regurgitation volume compared to ARF-1 (P = 0.0265).
  • No significant differences in stool frequency or consistency were observed between the two formulas.

Conclusions:

  • Both tested antiregurgitation formulas proved effective in reducing infant regurgitation.
  • ARF-2 was statistically more effective than ARF-1 in managing regurgitation.
  • Comparative studies are crucial for identifying optimal therapeutic options for infant feeding issues.
Abstract

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