A Growth and Hypoallergenicity Study of a New Formula for Infants With Cow Milk Allergy

Completed · Not applicable

Conditions studied: Cow Milk Allergy

In brief

This study involves the use of 2 different Neocate formulas: a control formula called Neocate Infant and a test Neocate formula. These kinds of formulas are for use in children from birth to 8 months of age with Cow Milk Allergy (CMA), other food allergies, and other gastrointestinal disorders. The purpose of this study is to compare the control and test Neocate formulas for safety, tolerability, and effectiveness (in promoting growth) when used in subjects with CMA. This study will also look at the test Neocate formula to see if it is hypoallergenic when used in subjects with CMA.

Key facts

Study ID

NCT00664768

Run by

Nutricia North America

People needed

126

Starts

2008-03-01

Expected to finish

2012-07-01

Last updated by the study team

2020-12-09

Who can join

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

You may qualify if…

• Subjects aged from birth to 8 months old with documented allergy to cow milk protein are eligible to enter the study. Subjects with other IgE or non IgE mediated allergies to food in addition to milk protein (e.g. multiple food allergy or an eosinophilic disorder) are also eligible to enter the study. However all subjects must have a confirmed allergy to milk confirmed by one of the following criteria, within two months prior to the baseline visit:
• Positive double-blind placebo controlled food challenge with cow milk
• A confirmed history of acute severe reaction after isolated accidental ingestion with a positive test result for IgE antibody
• Confirmed history of a reaction to cow milk protein with CM-specific IgE of >15kU/L for children over two years and > 5kU/L for children under two years.
• Confirmed clinical history of a reaction to cow milk protein with a positive skin prick test with a resulting wheal diameter greater or equal to 3mm.
• No confirmed clinical history of a reaction to cow milk protein subjects with a positive skin prick test with a resulting wheal diameter greater or equal to 8mm for children over 2 years and greater or equal to 6mm for children under 2 years.
• For children with an Allergic Eosinophilic Gastroenteritis (AEG), documentation of eosinophilic infiltration and resolution of symptoms on a diet that restricted cow milk (and other foods) with reoccurrence after re-administration of cow milk.
• Written informed consent / ability to give informed consent.
• These subjects are expected to consume a minimum intake of test formula to ensure an average daily intake, which provides at least 50% of their daily energy requirements,

You may not qualify if…

• All subjects
• Infants <5lb 8oz at birth
• Infants < 37 weeks gestation
• Infants with severe concurrent illness or major congenital malformations
• Suspected or documented systemic or congenital infections (e.g. human immunodeficiency virus)
• Unable to adhere to protocol instructions due to non compliance of parent or caregiver
• Investigator's uncertainty about the willingness or ability of the patient to comply with the protocol requirements
• Participation in any other studies involving investigational products concomitantly or within twenty eight days prior to entry into the study
• An infant of any personnel connected with the study
• Infants whose parent/caregiver is younger than the legal age of consent
• For these subjects the dietary consumption of other sources of prebiotics or probiotics is prohibited two weeks prior to inclusion in the study and during the study period.
• These subjects must not have received systemic antibiotics in the previous two weeks prior to entry into the study.

Where it is running

• Pendleton Pediatrics — Chandler, Arizona, United States
• Visions Clinical Research - Tucson — Tucson, Arizona, United States
• Children's Investigational Research Program, LLC (CHIRP) — Bentonville, Arkansas, United States
• Children's Hospital, LA — Los Angeles, California, United States
• David Geffen School of Medicine at UCLA — Los Angeles, California, United States
• Rosario B. Retino, MD, Inc — Ontario, California, United States
• Choc Psf, Amc — Orange, California, United States
• Nemours Children's Clinic — Jacksonville, Florida, United States
• Alzein Pediatrics — Evergreen Park, Illinois, United States
• Regional Research Specialists, LLC — Shreveport, Louisiana, United States
• Craig A. Spiegel, M.D. — Bridgeton, Missouri, United States
• Meridian Clinical Research, LLC — Omaha, Nebraska, United States
• Weill Cornell Medical College — New York, New York, United States
• Asheboro Research Associates — Asheboro, North Carolina, United States
• Duke University — Durham, North Carolina, United States
• Pediatrics, PLLC — Holly Springs, North Carolina, United States
• John Panuto, M.D. — Middleburg Heights, Ohio, United States
• The Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• Childrens Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States
• PI-Coor Clinical Research, LLC — Burke, Virginia, United States
• Virginia Commonwealth University — Richmond, Virginia, United States
• Advanced Pediatrics — Vienna, Virginia, United States

Full record on ClinicalTrials.gov

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