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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.
Purpose:
Regurgitation is a common physiological phenomenon in infants. The aim of the present study was to evaluate the efficacy of a new anti-regurgitation (AR) formula (Novalac), thickened with an innovative complex including fibres, on the daily number of regurgitations and to assess its impact on stool consistency and frequency.
Methods:
Infants younger than five months, presenting at least 5 regurgitations per day were recruited in this trial. The efficacy of the new formula on regurgitation (daily number and Vandenplas score), stool frequency and consistency were assessed at day 14 and 90. Growth data were recorded at each study visit.
Results:
Ninety babies (mean age 9.6±5.8 weeks) were included in the full analysis data set. The mean number of regurgitation episodes at inclusion was 7.3±3.4. In all infants, regurgitations improved after 2 weeks. The daily number of regurgitations decreased significantly (-6.3±3.3, p<0.001) including in those previously fed a thickened formula (-6.2±3.0, p<0.001). There was no significant change in stool consistency at day 14. After 3 months, 97.5% of infants had formed or soft stools. Growth was appropriate with a slight increase of weight-for-age z-score (from -0.5±1.0 to -0.1±0.9) and no change of weight-for length z-score (-0.1±1.1 to -0.1±-1.1).
Conclusion:
The new AR formula thickened with an innovative complex is very effective in reducing the daily number of regurgitations without having a negative impact on stools consistency.
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