Overview
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.
Description
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).
Eligibility
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
