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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
QUADRUPLE
Enrollment
66
Infant formula used for non breastfed children with colic
Infant formula used for non breastfed children
Dr Francine Gressin-Cohen
Antony, France
Hôpital privé d'Antony
Antony, France
Hôpital Robert Ballanger
Aulnay-sous-Bois, France
Crying duration per 24 hours
Time frame: 1 day before the first consumption ; 3 days before days 15 and 30
Growth Parameters
Time frame: Day 30
Clinical Tolerance
Time frame: 3 days before days 15 and 30
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
Number of regurgitations per day
Time frame: 3 days before days 15 and 30
Gas and abdominal distensions
Time frame: 3 days before days 15 and 30
Necessary Additive treatments
Time frame: 3 days before days 15 and 30
Parents' satisfaction
Time frame: Days 15 and 30
Agitation/Restlessness Period Duration
Time frame: 3 days before days 15 and 30
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Dr Brigitte Pacault
Boulogne-Billancourt, France
Dr Michel Dogneton
Boulogne-Billancourt, France
Dr Nassira Belaroussi Maamri
Boulogne-Billancourt, France
Dr KALINDJIAN
Issy-les-Moulineaux, France
Groupe Hospitalier de l'Institut Catholique de Lille (GHICL)
Lille, France
Dr Christophe Grillon
Meaux, France
Dr COUPRIE Claire
Paris, France
...and 2 more locations