Colic, Growth
Conditions
Keywords
Infant formula, Alpha-lactalbumin, Protein composition, Colic, Probiotics
Brief summary
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.
Detailed 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.
Interventions
OTHERModilac Dahlia 1
Infant formula used for non breastfed children with colic
OTHERModilac 1
Infant formula used for non breastfed children
Sponsors
Sodilac
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Weeks to 3 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Crying duration per 24 hours | 1 day before the first consumption ; 3 days before days 15 and 30 |
Secondary
| Measure | Time frame |
|---|---|
| Clinical Tolerance | 3 days before days 15 and 30 |
| Number of therapeutic failures (no diminution in the intensity or the frequency of the digestive symptoms) | Durind the 15 first days of the diet and during the 15 last days of the diet |
| Number of regurgitations per day | 3 days before days 15 and 30 |
| Growth Parameters | Day 30 |
| Necessary Additive treatments | 3 days before days 15 and 30 |
| Parents' satisfaction | Days 15 and 30 |
| Agitation/Restlessness Period Duration | 3 days before days 15 and 30 |
| Gas and abdominal distensions | 3 days before days 15 and 30 |
Countries
France
Outcome results
None listed