Evaluation of Safety and Efficacy of New Infant Formula in Infantile Colic

Evaluation of the Safety and Efficacy of New Infant Formula and Its Effects on the Gastrointestinal Tolerance (Crying Time) in Infantile Colic: a Double-blind, Randomized, Controlled Intervention Study

The study is conducted to examine the safety and efficacy of a new infant formula and its effects on the gastrointestinal tolerance in infants suffering from colic.

Primary hypothesis to be tested is: an infant formula with optimized composition improves colicky symptoms compared to a standard formula.

Inclusion Criteria:

• Healthy term infants
• Subjects appropriate for gestational age between 35 and 41 weeks
• Subjects between 15-60 days old
• Subjects with birth weight between 2500 and 4200 g and regular weight gain (≥150g / week)
• Diagnosis of infantile colic according to modified Wessel criteria (Crying episodes lasting 3 or more hours/day and occurring at least 3 days/week for at least 1 week)
• Subjects exclusively bottle-fed at study entrance
• Day care of the child only by mother/father
• Provide written informed consent in accordance with legal requirement

Exclusion Criteria:

• Neonatal problems (respiratory distress, asphyxia, Hypoglycaemia, sepsis, NEC)
• Clinical evidence of chronic illness or gastrointestinal disorders (GER, gastroenteritis)
• Assumption of any kind of medication (except vitamin D, vitamin K and fluoride prophylaxis) during the week before the beginning of the study and during the study period
• Subjects receiving formula for special medical purposes
• Exclusively breast-fed infants
• Feeding of supplemental Pro- and/or Prebiotics two weeks prior to inclusion
• Allergic diseases (manifest atopic dermatitis, cow's milk allergy)
• Participation in any other clinical intervention