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

Not Applicable

Terminated

• Conditions: Cow's Milk Allergy

• Registration Number: NCT01584245
• Lead Sponsor: Mead Johnson Nutrition

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-04-23
• Study First Submitted QC: 2012-04-23
• Study First Posted: 2012-04-24
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-15
• Last Update Posted: 2014-09-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Weight gain	12 weeks

Secondary Outcome Measures

Name	Time	Method
Allergic manifestations	12 weeks

Trial Locations

Locations (5)

Centre médical; 🇫🇷 Boulogne Billancourt, France

Hôpital Armand Trousseau; 🇫🇷 Paris, France

Hôpital Saint Vincent de Paul; 🇫🇷 Lille, France

Hôpital Necker Enfants Malades; 🇫🇷 Paris, France

Médecine Infantile 1; 🇫🇷 Vandoeuvre Lés Nancy, France