Clinical trial NCT01569776: Elemental Formula Hypoallergenicity
Official title: Evaluation of Hypoallergenicity of an Amino Acid-Based Infant Formula
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Food Hypersensitivity
Keywords: Cow milk allergy
CMA
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2012-04-03
Enrollment: 37
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The primary objective of this clinical trial is to determine whether a new amino acid-based formula is hypoallergenic as defined by the American Academy of Pediatrics (2000), demonstrating that the test formula does not provoke allergenic activity in 90% of infants or children with confirmed cow's milk allergy (CMA) with 95% confidence as compared to a commercially available hypoallergenic formula.


Eligibility criteria: Inclusion Criteria:

* Born at term (\>36 weeks gestation)
* 2 months to ≤12 years of age at enrollment
* Documented CMA within 6 months prior to enrollment
* Otherwise healthy
* Asthma, atopic dermatitis and/or rhinitis must be well-controlled, if applicable
* Expected daily intake of at least 8 oz (240ml) of the study formula during the open challenge phase
* Having obtained his/her legal representative's informed consent

Exclusion:

* Children consuming mother's milk at the time of inclusion and during the trial
* Any chromosomal or major congenital anomalies
* Any major gastrointestinal disease or abnormalities other than CMA
* Chronic medical diseases (ie seizure disorders, chronic lung disease, heart problems (heart murmurs okay)
* Immunodeficiency
* Anti-histamine use in 7 days prior to the first food challenge (eyedrops are permitted)
* Oral steroid use within 14 days prior to enrollment (intranasal and topical corticosteroid use are permitted)
* Unstable asthma
* Severe uncontrolled eczema
* Severe anaphylactic reaction to milk within the last 2 years
* Severe anaphylactic reaction to breastmilk within the last 2 years
* Subject who in the Investigator's assessment cannot be expected to adhere to the study protocol
* Currently participating in another clinical trial.

Primary outcomes:
measure: occurrence of allergic reactions
timeFrame: 14 days
Secondary outcomes:
measure: Digestive Tolerance
timeFrame: one week
Other outcomes:
Locations:
city: Huntington Beach
country: United States
facility: Pediatric Care Medical Group, Inc.
state: California
city: San Diego
country: United States
facility: Allergy & Asthma Medical Group and Research Center, A P.C.
state: California
city: Albany
country: United States
facility: Georgia Pollens Clinical Research Centers Inc.
state: Georgia
city: Hinsdale
country: United States
facility: Allergy & Asthma Physicians
state: Illinois
city: Evansville
country: United States
facility: Deaconess Clinic, Inc.
state: Indiana
city: New York
country: United States
facility: Mount Sinai Medical Center
state: New York
city: Newburgh
country: United States
facility: ENT & Allergy Associates
state: New York
city: Boerne
country: United States
facility: TTS Research
state: Texas
city: Richmond
country: United States
facility: Clinical Research Partners
state: Virginia
Study officials:
affiliation: Mount Sinai Department of Pediatrics
name: Anna Nowak-Wegrzyn, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Amari S, Shahrook S, Namba F, Ota E, Mori R. Branched-chain amino acid supplementation for improving growth and development in term and preterm neonates. Cochrane Database Syst Rev. 2020 Oct 2;10(10):CD012273. doi: 10.1002/14651858.CD012273.pub2.