Althera® Versus Nutramigen / Cow's Milk Intolerance

N/ACompletedNCT01727115

Société des Produits Nestlé (SPN)116 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

116

Conditions

Allergy

Interventions

Infant Formula FeedingOTHER

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

Eligibility

Sex: ALLMax age: 6 Months

Medical Language ↔ Plain English

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

Locations (14)

ASZ

Aalst, Aalst, Belgium

ZNA Middelheim

Antwerp, Antwerp, Belgium

CHU Huderf

Brussels, Brussels Capital, Belgium

Outcomes

Primary Outcomes

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

Time frame: 4 weeks

Secondary Outcomes

To assess whether the 2 groups have comparable changes in weight, length and head circumference

weight, length, head circumference

Time frame: 1 year

Data from ClinicalTrials.gov

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