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Elemental Formula Hypoallergenicity

Primary Purpose

Food Hypersensitivity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Amino Acid formula
Commercially available Amino Acid Formula
Sponsored by
Société des Produits Nestlé (SPN)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Food Hypersensitivity focused on measuring Cow milk allergy, CMA

Eligibility Criteria

2 Months - 12 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Pediatric Care Medical Group, Inc.
  • Allergy & Asthma Medical Group and Research Center, A P.C.
  • Georgia Pollens Clinical Research Centers Inc.
  • Allergy & Asthma Physicians
  • Deaconess Clinic, Inc.
  • Mount Sinai Medical Center
  • ENT & Allergy Associates
  • TTS Research
  • Clinical Research Partners

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

New Amino Acid formula

Control formula

Arm Description

Commercially available Amino Acid infant formula

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
March 30, 2012
Last Updated
June 24, 2013
Sponsor
Société des Produits Nestlé (SPN)
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1. Study Identification

Unique Protocol Identification Number
NCT01569776
Brief Title
Elemental Formula Hypoallergenicity
Official Title
Evaluation of Hypoallergenicity of an Amino Acid-Based Infant Formula
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Société des Produits Nestlé (SPN)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Food Hypersensitivity
Keywords
Cow milk allergy, CMA

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
New Amino Acid formula
Arm Type
Experimental
Arm Title
Control formula
Arm Type
Active Comparator
Arm Description
Commercially available Amino Acid infant formula
Intervention Type
Other
Intervention Name(s)
Amino Acid formula
Intervention Description
Amino Acid baby formula
Intervention Type
Other
Intervention Name(s)
Commercially available Amino Acid Formula
Intervention Description
Hypoallergenic Baby formula
Primary Outcome Measure Information:
Title
occurrence of allergic reactions
Description
occurrence of allergic reactions to double-blind placebo controlled food challenge (DBPCFC)
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Digestive Tolerance
Description
gastrointestinal tolerance and formula intake recorded during the open challenge phase.
Time Frame
one week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Months
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna Nowak-Wegrzyn, MD
Organizational Affiliation
Mount Sinai Department of Pediatrics
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pediatric Care Medical Group, Inc.
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92647
Country
United States
Facility Name
Allergy & Asthma Medical Group and Research Center, A P.C.
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Georgia Pollens Clinical Research Centers Inc.
City
Albany
State/Province
Georgia
ZIP/Postal Code
31707
Country
United States
Facility Name
Allergy & Asthma Physicians
City
Hinsdale
State/Province
Illinois
ZIP/Postal Code
60521
Country
United States
Facility Name
Deaconess Clinic, Inc.
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47713
Country
United States
Facility Name
Mount Sinai Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
ENT & Allergy Associates
City
Newburgh
State/Province
New York
ZIP/Postal Code
12550
Country
United States
Facility Name
TTS Research
City
Boerne
State/Province
Texas
ZIP/Postal Code
78006
Country
United States
Facility Name
Clinical Research Partners
City
Richmond
State/Province
Virginia
ZIP/Postal Code
25233
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
33006765
Citation
Amari S, Shahrook S, Namba F, Ota E, Mori R. Branched-chain amino acid supplementation for improving growth and development in term and preterm neonates. Cochrane Database Syst Rev. 2020 Oct 2;10(10):CD012273. doi: 10.1002/14651858.CD012273.pub2.
Results Reference
derived

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Elemental Formula Hypoallergenicity

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