Evaluation of the Tolerance and Safety of a New Partly Fermented Anti-regurgitation Infant Formula

Inclusion criteria

• ✓. Singleton healthy term infant aged 3 - 13 weeks;
• ✓. Gestational age at birth 37- 42 weeks;
• ✓. Normal birth weight for gestational age and gender i.e. 10th to 90th percentile compared to the WHO or local growth charts;
• ✓. Infants with regurgitation that are otherwise healthy, based upon the following criteria: 1) Regurgitation of 2 or more times per day for 1 or more weeks according to reported history, 2) an indication for the use of AR formula according to the investigator at screening/randomisation.
• ✓. Fully formula fed for at least 7 days before screening/randomisation;
• ✓. Written informed consent from the parent(s) and/or legally acceptable representative(s), aged ≥ 18 years.