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.
Dataset ; Gastroesophageal Reflux ; Humans ; Infant ; Infant Formula ; Physiological Phenomena

Purpose: The present study assessed the role of an amino acid-based formula (AAF) in the growth of infants with cow's milk protein allergy (CMPA). Methods: Non-breastfed, term infants aged 0–6 months with symptoms suggestive of CMPA were recruited from 10 pediatric centers in China. After enrollment, infants were started on AAF for two weeks, followed by an open food challenge (OFC) with cow's milk-based formula (CMF). Infants with confirmed CMPA remained on AAF until 9 months of age, in conjunction with a cow's milk protein-free complementary diet. Body weight, length, and head circumference were measured at enrollment and 9 months of age. Measurements were converted to weight-for-age, length-for-age, and head circumference-for-age Z scores (WAZ, LAZ, HCAZ), based on the World Health Organization growth reference. Results: Of 254 infants (median age 16.1 weeks, 50.9% male), 218 (85.8%) were diagnosed with non-IgE-mediated CMPA, 33 (13.0%) tolerated CMF, and 3 (1.2%) did not complete the OFC. The mean WAZ decreased from 0.119 to −0.029 between birth and enrollment (p=0.067), with significant catch-up growth to 0.178 at 9 months of age (p=0.012) while being fed the AAF. There were no significant changes in LAZ (0.400 vs. 0.552; p=0.214) or HCAZ (−0.356 vs. −0.284; p=0.705) from the time of enrollment to age 9 months, suggesting normal linear and head growth velocity. Conclusion The amino acid-based study formula, in conjunction with a cow's milk proteinfree complementary diet, supported normal growth till 9 months of age in a cohort of Chinese infants with challenge-confirmed non-IgE-mediated CMPA.

Purpose: The present study assessed the role of an amino acid-based formula (AAF) in the growth of infants with cow's milk protein allergy (CMPA). Methods: Non-breastfed, term infants aged 0–6 months with symptoms suggestive of CMPA were recruited from 10 pediatric centers in China. After enrollment, infants were started on AAF for two weeks, followed by an open food challenge (OFC) with cow's milk-based formula (CMF). Infants with confirmed CMPA remained on AAF until 9 months of age, in conjunction with a cow's milk protein-free complementary diet. Body weight, length, and head circumference were measured at enrollment and 9 months of age. Measurements were converted to weight-for-age, length-for-age, and head circumference-for-age Z scores (WAZ, LAZ, HCAZ), based on the World Health Organization growth reference. Results: Of 254 infants (median age 16.1 weeks, 50.9% male), 218 (85.8%) were diagnosed with non-IgE-mediated CMPA, 33 (13.0%) tolerated CMF, and 3 (1.2%) did not complete the OFC. The mean WAZ decreased from 0.119 to −0.029 between birth and enrollment (p=0.067), with significant catch-up growth to 0.178 at 9 months of age (p=0.012) while being fed the AAF. There were no significant changes in LAZ (0.400 vs. 0.552; p=0.214) or HCAZ (−0.356 vs. −0.284; p=0.705) from the time of enrollment to age 9 months, suggesting normal linear and head growth velocity. Conclusion The amino acid-based study formula, in conjunction with a cow's milk proteinfree complementary diet, supported normal growth till 9 months of age in a cohort of Chinese infants with challenge-confirmed non-IgE-mediated CMPA.