Clinical trial NCT00929292: Safety and Tolerance Study of Alpha-Lactalbumin Enriched and Probiotic-Supplemented Infant Formula in Infants With Colic
Official title: Study of Growth and Gastrointestinal Tolerance of an Alpha-Lactalbumin Enriched and Probiotic-Supplemented Infant Formula in Infants With Colic.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Growth
Colic
Keywords: Infant formula
Alpha-lactalbumin
Protein composition
Colic
Probiotics
Lead sponsor: Sodilac
Sponsor class: INDUSTRY
First posted: 2009-06-29
Enrollment: 66
Sex: ALL
Minimum age (years): 3
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

Eligibility criteria: 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

Primary outcomes:
measure: Crying duration per 24 hours
timeFrame: 1 day before the first consumption ; 3 days before days 15 and 30
Secondary outcomes:
measure: Growth Parameters
timeFrame: Day 30
measure: Clinical Tolerance
timeFrame: 3 days before days 15 and 30
measure: Number of therapeutic failures (no diminution in the intensity or the frequency of the digestive symptoms)
timeFrame: Durind the 15 first days of the diet and during the 15 last days of the diet
measure: Number of regurgitations per day
timeFrame: 3 days before days 15 and 30
measure: Gas and abdominal distensions
timeFrame: 3 days before days 15 and 30
measure: Necessary Additive treatments
timeFrame: 3 days before days 15 and 30
measure: Parents' satisfaction
timeFrame: Days 15 and 30
measure: Agitation/Restlessness Period Duration
timeFrame: 3 days before days 15 and 30
Other outcomes:
Locations:
city: Antony
country: France
facility: Dr Francine Gressin-Cohen
city: Antony
country: France
facility: Hôpital privé d'Antony
city: Aulnay sous Bois
country: France
facility: Hôpital Robert Ballanger
city: Boulogne Billancourt
country: France
facility: Dr Brigitte Pacault
city: Boulogne Billancourt
country: France
facility: Dr Michel Dogneton
city: Boulogne Billancourt
country: France
facility: Dr Nassira Belaroussi Maamri
city: Issy-les-Moulineaux
country: France
facility: Dr KALINDJIAN
city: Lille
country: France
facility: Groupe Hospitalier de l'Institut Catholique de Lille (GHICL)
city: Meaux
country: France
facility: Dr Christophe Grillon
city: Paris
country: France
facility: Dr COUPRIE Claire
city: Paris
country: France
facility: Dr RONZIER Monique
city: Roncq
country: France
facility: Dr Locquet André
Study officials:
affiliation: Hôpital Saint Vincent de Paul
name: Christophe Dupont, PhD
role: PRINCIPAL_INVESTIGATOR
References: