Althera® Versus Nutramigen / Cow's Milk Intolerance

Nestlé

Status: Completed

Conditions: Allergy

Treatments: Other: Infant Formula Feeding

Study type: Interventional

Funder types: Industry

Identifiers

NCT01727115

06.04.INF

Details and patient eligibility

About

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

Enrollment: 116 patients

Sex: All

Ages: Under 6 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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116 participants in 2 patient groups

NUTRAMIGEN®

Active Comparator group

Description:

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

Treatment:

Other: Infant Formula Feeding

ALTHERA®

Experimental group

Description:

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

Treatment:

Other: Infant Formula Feeding