Skip to main content
OpenTrials
Completed

NCT Number: NCT01569776

Elemental Formula Hypoallergenicity

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Food Hypersensitivity Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Milk Hypersensitivity

Age range

2 month–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Amino Acid Formula

Other

Amino Acid baby formula

Commercially available Amino Acid Formula

Other

Hypoallergenic Baby formula

Primary outcomes

  1. occurrence of allergic reactions

    Time frame: 14 days

    occurrence of allergic reactions to double-blind placebo controlled food challenge (DBPCFC)

Secondary outcomes

  1. Digestive Tolerance

    Time frame: one week

    gastrointestinal tolerance and formula intake recorded during the open challenge phase.

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Official study title

Evaluation of Hypoallergenicity of an Amino Acid-Based Infant Formula

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Apr 3, 2012
Registry last updated
Jun 26, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.