A Study to Monitor the Use of an Amino Acid-Based Infant Formula

Société des Produits Nestlé (SPN)29 sites in 1 country144 target enrollmentJanuary 2017

ConditionsCow's Milk Protein Allergy Eosinophilic Gastrointestinal Disorders Malabsorption/Maldigestion Short Bowel Syndrome Multiple Food Allergies

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Cow's Milk Protein Allergy
Sponsor: Société des Produits Nestlé (SPN)
Enrollment: 144
Locations: 29
Primary Endpoint: Adverse events
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

To assess the frequency and nature of adverse events in infants fed a free amino acid based infant formula.

Detailed Description

Prospective, post-market surveillance program to be conducted in the United States (US). Infant will be invited to enroll by their healthcare provider who recommends the use of a free amino acid based infant formula

Registry

clinicaltrials.gov

Start Date

January 2017

End Date

January 2019

Last Updated

6 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Société des Produits Nestlé (SPN)

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Infants who use a free amino acid based Infant formula during their first year of life including:
•Those that are currently consuming the formula at the time of enrollment
•Those for whom consumption of the formula is planned
•At least one parent/guardian is willing to provide written informed consent form (ICF) for participation in the surveillance program