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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01584245

Enrollment

Registered

2012-04-24

Start date

2012-02-29

Completion date

2014-07-31

Last updated

2014-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cow's Milk Allergy

Brief summary

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

Interventions

OTHERAmino Acid formula

Study design

Allocation

Intervention model

SINGLE_GROUP

Eligibility

Sex/Gender

ALL

Age

1 Months to 12 Months

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

Design outcomes

Primary

Measure	Time frame
Weight gain	12 weeks

Secondary

Measure	Time frame
Allergic manifestations	12 weeks

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026