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.
≥ 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
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)
United Pharmaceuticals
Lead sponsor
Statitec
Collaborator