Althera® Versus Nutramigen / Cow's Milk Intolerance

Comparison of Two Extensively Hydrolyzed Formulas for the Treatment of Children With Cow's Milk Intolerance

The primary objective of this study is to demonstrate that ALTHERA® is equal or superior in efficacy than NUTRAMIGEN®

Inclusion Criteria:

• Infants from few days of life until 6 months of age
• Birth weight : between 2.500g and 4.500g
• Full term: gestational age between 37 and 42 weeks
• Singleton birth
• Suspicion of a mild/moderate Cow's Milk Proteins Intolerance (CMPI)
• Having obtained the Informed Consent by the Parents or the legal guardian

Exclusion Criteria:

• Exclusive breastfeeding at time of enrolment
• Having been treated before enrolment with an extensively hydrolysed formula
• Disease impairing a normal gut transit (like pyloric stenosis)
• Intolerance to lactose (if already known)
• Receiving an antibiotic treatment at the time of enrolment
• Severe or chronic diarrhea
• Failure to thrive
• Neurologic diseases
• Receiving a medical treatment which could interfere with the protocol or after a surgical intervention
• Infants whose parents / caregivers who cannot be expected to comply with treatment
• Currently participating or having participated in another interventional clinical trial