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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Study of Growth and Gastrointestinal Tolerance of an Alpha-Lactalbumin Enriched and Probiotic-Supplemented Infant Formula in Infants With Colic.

Conditions
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Growth, Colic

Intervention / Treatment
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* Other: Modilac Dahlia 1
* Other: Modilac 1


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Weeks
Maximum Age: 3 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Modilac Dahlia 1<br>Formula enriched with alpha-lactalbumin and containing a probiotic | Other: Modilac Dahlia 1<br>* Infant formula used for non breastfed children with colic<br>* Other names: Dahlia;|
| Placebo Comparator: Modilac 1<br>Regular milk | Other: Modilac 1<br>* Infant formula used for non breastfed children<br>* Other names: Modilac;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Crying duration per 24 hours |  | 1 day before the first consumption ; 3 days before days 15 and 30 | 

Secondary Outcome Measures

| Outcome Measure | 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) |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Infant formula, Alpha-lactalbumin, Protein composition, Colic, Probiotics