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

Sodilac

Status and phase

Completed

Phase 3

Conditions

Growth

Colic

Treatments

Other: Modilac Dahlia 1

Other: Modilac 1

Study type

Interventional

Funder types

Industry

Identifiers

NCT00929292

DAH-CL3-001

Details and patient eligibility

About

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.

Full description

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.

Enrollment

66 patients

Sex

All

Ages

3 weeks to 3 months old

Volunteers

No Healthy Volunteers

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