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

Mead Johnson Nutrition

Status: Terminated

Conditions: Cow's Milk Allergy

Treatments: Other: Amino Acid formula

Study type: Interventional

Funder types: Industry

Identifiers

NCT01584245

6009

Details and patient eligibility

About

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

Enrollment: 32 patients

Sex: All

Ages: 1 to 12 months old

Volunteers: No Healthy Volunteers

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