Elemental Formula Hypoallergenicity

Nestlé

Status: Completed

Conditions: Food Hypersensitivity

Treatments: Other: Commercially available Amino Acid Formula; Other: Amino Acid formula

Study type: Interventional

Funder types: Industry

Identifiers

NCT01569776

09.55.PED

Details and patient eligibility

About

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.

Enrollment: 37 patients

Sex: All

Ages: 2 months to 12 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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37 participants in 2 patient groups

New Amino Acid formula

Experimental group

Treatment:

Other: Amino Acid formula

Control formula

Active Comparator group

Description:

Commercially available Amino Acid infant formula

Treatment:

Other: Commercially available Amino Acid Formula