Safety and Tolerance Study of Alpha-Lactalbumin Enriched and Probiotic-Supplemented Infant Formula in Infants With Colic

Study of Growth and Gastrointestinal Tolerance of an Alpha-Lactalbumin Enriched and Probiotic-Supplemented Infant Formula in Infants With Colic.

The purpose of this study is to evaluate the nutritional adequacy, the digestive tolerance and the effect on colic of an alpha-lactalbumin-enriched and probiotic-supplemented infant formula.

This double-blind, placebo-controlled study was undertaken with 66 healthy infants with colic, aged 3 weeks to 3 months, fed a month either with the experimental formula (EF) or with the control formula (CF) and evaluated for efficacy and safety parameters at days 15 and 30.

Both parents provided informed written consent.

Inclusion Criteria:

• Healthy term infants with a gestational age ranging from 37 to 42 weeks
• Non breastfed children
• Infants with normal growth
• Infants presenting colic defined as crying periods at least 3 hours per days, 3 days per weeks, for more than 3 weeks
• These crying periods could be associated with other digestive troubles(gas, abdominal distensions, regurgitations)
• Apgar score > 5 to 7 minutes

Exclusion Criteria:

• Infants with severe regurgitations
• Newborn currently participating in another trial
• Infants presenting a metabolic, nervous or organic disease able to interfere with the study
• Infants presenting lactose intolerance
• Evidence of protein cow's milk allergy
• Mother who wants to keep breasfeeding