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

Completed

Conditions studied: Cow's Milk Protein Allergy, Eosinophilic Gastrointestinal Disorders, Malabsorption/Maldigestion, Short Bowel Syndrome, Multiple Food Allergies

In brief

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

Key facts

Study ID

NCT02953223

Run by

Société des Produits Nestlé (SPN)

People needed

144

Starts

2017-01-01

Expected to finish

2019-01-01

Last updated by the study team

2020-02-11

Who can join

Age: 0 and older, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Infants <37 weeks of corrected gestation age (CGA) at time of enrollment

Where it is running

• Pediatric Multicare West — Lakeside, Arizona, United States
• Phoenix Children's Hospital — Phoenix, Arizona, United States
• University of Arizona — Tucson, Arizona, United States
• Applied Research Center of Arkansas — Little Rock, Arkansas, United States
• Sutter Institute of Medical Research — Roseville, California, United States
• Pioneer Clinical Research — Coconut Creek, Florida, United States
• Children's Center for GI and Nutrition — Hollywood, Florida, United States
• Childerns Health Center, PA — Homestead, Florida, United States
• Homestead Medical Clinic — Miami, Florida, United States
• Next Phase Research — Virginia Gardens, Florida, United States
• Children's Gastroenterology Speciality — Glenview, Illinois, United States
• Childrens Health Care — Wheeling, Illinois, United States
• Springs Medical Research — Owensboro, Kentucky, United States
• Acadiana Pediatric Gastro and Hep — Lafayette, Louisiana, United States
• Tulane University Health Sciences Center — Metairie, Louisiana, United States
• Conduct Clinical Trials — Flushing, New York, United States
• The Feinstein Institute for Medical Research — Great Neck, New York, United States
• State University of New York (SUNY) — Syracuse, New York, United States
• Duke University — Durham, North Carolina, United States
• Wake Forest Baptist Health — Winston-Salem, North Carolina, United States
• UH Rainbow Babies & Children's Hospital — Cleveland, Ohio, United States
• University of Oklahoma, Health Sciences Center — Oklahoma City, Oklahoma, United States
• Milestones Pediatric Care — Tulsa, Oklahoma, United States
• Cyn3rgy Research — Gresham, Oregon, United States
• Invocare Clinical Research Center — West Columbia, South Carolina, United States

Full record on ClinicalTrials.gov

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