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

• Growth Parameters [ Time Frame: Day 30 ] [ Designated as safety issue: Yes ]
• Clinical Tolerance [ Time Frame: 3 days before days 15 and 30 ] [ Designated as safety issue: No ]
• Number of therapeutic failures (no diminution in the intensity or the frequency of the digestive symptoms) [ Time Frame: Durind the 15 first days of the diet and during the 15 last days of the diet ] [ Designated as safety issue: No ]
• Number of regurgitations per day [ Time Frame: 3 days before days 15 and 30 ] [ Designated as safety issue: No ]
• Gas and abdominal distensions [ Time Frame: 3 days before days 15 and 30 ] [ Designated as safety issue: No ]
• Necessary Additive treatments [ Time Frame: 3 days before days 15 and 30 ] [ Designated as safety issue: No ]
• Parents' satisfaction [ Time Frame: Days 15 and 30 ] [ Designated as safety issue: No ]
• Agitation/Restlessness Period Duration [ Time Frame: 3 days before days 15 and 30 ] [ Designated as safety issue: No ]

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.

• Growth
• Colic

• Other: Modilac Dahlia 1
  Infant formula used for non breastfed children with colic
  Other Name: Dahlia
• Other: Modilac 1
  Infant formula used for non breastfed children
  Other Name: Modilac

• Experimental: Modilac Dahlia 1
  Formula enriched with alpha-lactalbumin and containing a probiotic
  Intervention: Other: Modilac Dahlia 1
• Placebo Comparator: Modilac 1
  Regular milk
  Intervention: Other: Modilac 1

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