Elemental Formula Hypoallergenicity

Not Applicable

Completed

• Conditions: Food Hypersensitivity
• Interventions: Other: Amino Acid formula; Other: Commercially available Amino Acid Formula

• Registration Number: NCT01569776
• Lead Sponsor: Société des Produits Nestlé (SPN)

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-03-30
• Study First Submitted QC: 2012-03-30
• Study Start: 2012-04
• Study First Posted: 2012-04-03
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-24
• Last Update Posted: 2013-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
New Amino Acid formula	Amino Acid formula	-
Control formula	Commercially available Amino Acid Formula	Commercially available Amino Acid infant formula

Primary Outcome Measures

Name	Time	Method
occurrence of allergic reactions	14 days	occurrence of allergic reactions to double-blind placebo controlled food challenge (DBPCFC)

Secondary Outcome Measures

Name	Time	Method
Digestive Tolerance	one week	gastrointestinal tolerance and formula intake recorded during the open challenge phase.

Trial Locations

Locations (9)

Georgia Pollens Clinical Research Centers Inc.; 🇺🇸 Albany, Georgia, United States

ENT & Allergy Associates; 🇺🇸 Newburgh, New York, United States

Pediatric Care Medical Group, Inc.; 🇺🇸 Huntington Beach, California, United States

Allergy & Asthma Medical Group and Research Center, A P.C.; 🇺🇸 San Diego, California, United States

Allergy & Asthma Physicians; 🇺🇸 Hinsdale, Illinois, United States

Deaconess Clinic, Inc.; 🇺🇸 Evansville, Indiana, United States

Mount Sinai Medical Center; 🇺🇸 New York, New York, United States

TTS Research; 🇺🇸 Boerne, Texas, United States

Clinical Research Partners; 🇺🇸 Richmond, Virginia, United States