Elemental Formula Hypoallergenicity

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Nestlé

ClinicalTrials.gov Identifier:

NCT01569776

First received: March 30, 2012

Last updated: January 16, 2013

Last verified: January 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

March 30, 2012

Last Updated Date

January 16, 2013

Start Date ^ICMJE

April 2012

Primary Completion Date

November 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

occurrence of allergic reactions [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]

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

Original Primary Outcome Measures ^ICMJE

Hypoallergenicity [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]

To demonstrate that the test formula does not provoke allergenic activity

Change History

Complete list of historical versions of study NCT01569776 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Digestive Tolerance [ Time Frame: one week ] [ Designated as safety issue: No ]

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

Original Secondary Outcome Measures ^ICMJE

Digestive Tolerance [ Time Frame: one week ] [ Designated as safety issue: No ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Elemental Formula Hypoallergenicity

Official Title ^ICMJE

Evaluation of Hypoallergenicity of an Amino Acid-Based Infant Formula

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

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

Condition ^ICMJE

Food Hypersensitivity

Intervention ^ICMJE

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

Study Arm (s)

Experimental: New Amino Acid formula
Intervention: Other: Amino Acid formula
Active Comparator: Control formula
Commercially available Amino Acid infant formula

Intervention: Other: Commercially available Amino Acid Formula

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

July 2013

Primary Completion Date

November 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

2 Months to 12 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01569776

Other Study ID Numbers ^ICMJE

09.55.PED

Has Data Monitoring Committee

Responsible Party

Nestlé

Study Sponsor ^ICMJE

Nestlé

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Anna Nowak-Wegrzyn, MD

Mount Sinai Department of Pediatrics

Information Provided By

Nestlé

Verification Date

January 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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