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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Modilac Dahlia 1 | Experimental | Formula enriched with alpha-lactalbumin and containing a probiotic |
|
| Modilac 1 | Placebo Comparator | Regular milk |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Modilac Dahlia 1 | Other | Infant formula used for non breastfed children with colic |
|
| Measure | Description | Time Frame |
|---|---|---|
| Crying duration per 24 hours | 1 day before the first consumption ; 3 days before days 15 and 30 |
| Measure | Description | Time Frame |
|---|---|---|
| Growth Parameters | Day 30 | |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christophe Dupont, PhD | Hôpital Saint Vincent de Paul | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr Francine Gressin-Cohen | Antony | 92160 | France | |||
| Hôpital privé d'Antony |
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| Modilac 1 | Other | Infant formula used for non breastfed children |
|
|
| 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 |
| Gas and abdominal distensions | 3 days before days 15 and 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 |
| Antony |
| 92166 |
| France |
| Hôpital Robert Ballanger | Aulnay-sous-Bois | 93602 | France |
| Dr Brigitte Pacault | Boulogne-Billancourt | 92100 | France |
| Dr Michel Dogneton | Boulogne-Billancourt | 92100 | France |
| Dr Nassira Belaroussi Maamri | Boulogne-Billancourt | 92100 | France |
| Dr KALINDJIAN | Issy-les-Moulineaux | 92130 | France |
| Groupe Hospitalier de l'Institut Catholique de Lille (GHICL) | Lille | 59020 | France |
| Dr Christophe Grillon | Meaux | 77100 | France |
| Dr COUPRIE Claire | Paris | 75013 | France |
| Dr RONZIER Monique | Paris | 75015 | France |
| Dr Locquet André | Roncq | 59223 | France |
| ID | Term |
|---|---|
| D003085 | Colic |
| ID | Term |
|---|---|
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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