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Updated: May 11, 2026
04:53
A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
Published on: September 20, 2019
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
Summary
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.
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