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Elemental Formula Hypoallergenicity

Evaluation of Hypoallergenicity of an Amino Acid-Based Infant Formula

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01569776
Enrollment
37
Registered
2012-04-03
Start date
2012-04-30
Completion date
2013-04-30
Last updated
2013-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Food Hypersensitivity

Keywords

Cow milk allergy, CMA

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.

Interventions

Amino Acid baby formula

Hypoallergenic Baby formula

Sponsors

Société des Produits Nestlé (SPN)
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
2 Months to 12 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
occurrence of allergic reactions14 daysoccurrence of allergic reactions to double-blind placebo controlled food challenge (DBPCFC)

Secondary

MeasureTime frameDescription
Digestive Toleranceone weekgastrointestinal tolerance and formula intake recorded during the open challenge phase.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026