Study on the Efficacy and Tolerance of a New Anti-regurgitation Infant Formula (STELLAR)

Study on the Efficacy and Tolerance of a New Anti-regurgitation Infant Formula: a Double-blind, Randomized, Controlled, International, Multi-centric Clinical Trial

The aim of the study is to assess the effectiveness of this new formula on regurgitations and secondarily its effect on digestive tolerance through a randomized, controlled, double-blind trial against a comparator.

The study duration is 1 month and 2 days. It is possible to add 2 additional months (optional).

The 2 first days (from D-3 to D0) correspond to the pre-selection period. These 2 days are followed by the follow-up month (from D0 to D30). It is possible to add an optional follow up of 2 months (form D30 to D90).

Inclusion Criteria:

• ≥ 2 regurgitation episodes per day during the last 2 weeks and ≥ 4 regurgitation episodes per day in average during the last 2 days,
• exclusive or predominant formula feeding
• whose parents signed informed consent

Exclusion Criteria:

• preterm infants or birthweight <2500g
• Post enteritis lactose intolerance
• Suspected or diagnosed cow's milk protein allergy requiring an eviction diet
• Use of medications that may interfere with regurgitation or gastrointestinal transit (such as alginates, laxatives, antibiotics...). All these medications have to be stopped at least 7 days before inclusion visit (V1)
• Infants presenting with any situation which, according to the investigator, may interfere with the study participation, or lead to a particular risk for the subject