Althera® Versus Nutramigen / Cow's Milk Intolerance

Study Overview
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Brief Summary
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The primary objective of this study is to demonstrate that ALTHERA® is equal or superior in efficacy than NUTRAMIGEN®

Official Title
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Comparison of Two Extensively Hydrolyzed Formulas for the Treatment of Children With Cow's Milk Intolerance

Conditions
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Allergy

Intervention / Treatment
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* Other: Infant Formula Feeding


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Infants from few days of life until 6 months of age Birth weight : between 2.500g and 4.500g Full term: gestational age between 37 and 42 weeks Singleton birth Suspicion of a mild/moderate Cow's Milk Proteins Intolerance (CMPI) Having obtained the Informed Consent by the Parents or the legal guardian Exclusion Criteria: Exclusive breastfeeding at time of enrolment Having been treated before enrolment with an extensively hydrolysed formula Disease impairing a normal gut transit (like pyloric stenosis) Intolerance to lactose (if already known) Receiving an antibiotic treatment at the time of enrolment Severe or chronic diarrhea Failure to thrive Neurologic diseases Receiving a medical treatment which could interfere with the protocol or after a surgical intervention Infants whose parents / caregivers who cannot be expected to comply with treatment Currently participating or having participated in another interventional clinical trial

Ages Eligible for Study
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Maximum Age: 6 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

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: NUTRAMIGEN®<br>Subjects are orally fed ad libitum (following guidelines printed on the labels). Subjects will receive the Nutramigen® formula for a 4 week period Then depending of the result of the challenge test we have the following possibilities: If the test is positive: The children continue the formula Nutramigen® If the test is negative: A Follow up formula is given (Nan pro2) if child > 6 months (Nan pro1) if child < 6 months | Other: Infant Formula Feeding<br>* Assigned formula (Althera® or Nutramigen®) for a 4 weeks period. If the challenge is positive: The children continue the assigned formula If the challenge is negative: A Follow up formula is given (Nan pro2) if child > 6 months (Nan pro1) if child < 6 months<br>|
| Experimental: ALTHERA®<br>Subjects are orally fed ad libitum (following guidelines printed on the labels). Subjects will receive the Althera® formula for a 4 week period Then depending of the result of the challenge test we have the following possibilities: If the test is positive: The children continue the formula Althera® If the test is negative: A Follow up formula is given (Nan pro2) if child > 6 months (Nan pro1) if child < 6 months | Other: Infant Formula Feeding<br>* Assigned formula (Althera® or Nutramigen®) for a 4 weeks period. If the challenge is positive: The children continue the assigned formula If the challenge is negative: A Follow up formula is given (Nan pro2) if child > 6 months (Nan pro1) if child < 6 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome are regurgitations/vomiting, stool consistency, atopic eczema, urticaria and respiratory symptoms after 4 weeks of treatment. | regurgitations/vomiting, stool consistency, atopic eczema, urticaria and respiratory symptoms | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess whether the 2 groups have comparable changes in weight, length and head circumference | weight, length, head circumference | 1 year |