Elemental Formula Hypoallergenicity

Food Hypersensitivity Clinical Trial

Official title:

Evaluation of Hypoallergenicity of an Amino Acid-Based Infant Formula

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01569776
• Other study ID #: 09.55.PED
• Status: Completed
• Phase: N/A
• First received: March 30, 2012
• Last updated: June 24, 2013
• Start date: April 2012
• Est. completion date: April 2013

Study information

• Verified date: June 2013
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Months to 12 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Food Hypersensitivity
• Hypersensitivity

Intervention

Other:
• Amino Acid formula
Amino Acid baby formula
• Commercially available Amino Acid Formula
Hypoallergenic Baby formula

Locations

Country	Name	City	State
United States	Georgia Pollens Clinical Research Centers Inc.	Albany	Georgia
United States	TTS Research	Boerne	Texas
United States	Deaconess Clinic, Inc.	Evansville	Indiana
United States	Allergy & Asthma Physicians	Hinsdale	Illinois
United States	Pediatric Care Medical Group, Inc.	Huntington Beach	California
United States	Mount Sinai Medical Center	New York	New York
United States	ENT & Allergy Associates	Newburgh	New York
United States	Clinical Research Partners	Richmond	Virginia
United States	Allergy & Asthma Medical Group and Research Center, A P.C.	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	occurrence of allergic reactions	occurrence of allergic reactions to double-blind placebo controlled food challenge (DBPCFC)	14 days	Yes
Secondary	Digestive Tolerance	gastrointestinal tolerance and formula intake recorded during the open challenge phase.	one week	No