Evaluation of the Efficacy of an Amino Acid Based Formula in Infants

N/ATerminatedNCT01584245

Mead Johnson Nutrition32 enrolled

Overview

This clinical trial will evaluate the efficacy of an amino acid formula in infants with allergic manifestations.

Study Type

INTERVENTIONAL

Allocation

Enrollment

Conditions

Cow's Milk Allergy

Interventions

Amino Acid formulaOTHER

Eligibility

Sex: ALLMin age: 1 MonthMax age: 12 Months

Medical Language ↔ Plain English

Inclusion Criteria: * Weight loss within the past 4 weeks * Infants 1-12 months of age feeding a hypoallergenic formula for at least 2 weeks * Birth weight greater than or equal to 1500 grams * Solely enteral fed * Infants with at least one persistent allergy symptom * No change in medication within 10 days of beginning the study and no plans for change during the first 10 days of the study * Signed informed consent Exclusion Criteria: * History of underlying condition which, in the Investigator's opinion, could interfere with normal growth, development, or assessment of the participant * Metabolic disease requiring special attention

Locations (5)

Centre médical

Boulogne-Billancourt, France

Hôpital Saint Vincent de Paul

Lille, France

Hôpital Armand Trousseau

Paris, France

Hôpital Necker Enfants Malades

Paris, France

Médecine Infantile 1

Outcomes

Primary Outcomes

Weight gain

Time frame: 12 weeks

Secondary Outcomes

Allergic manifestations

Time frame: 12 weeks

Data from ClinicalTrials.gov

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