Extensively Hydrolyzed Formula: Hypoallergenicity

Evaluation of Hypoallergenicity of a 100% Whey, Extensively Hydrolyzed Infant Formula

The primary objective of this clinical trial is to determine whether a new extensively hydrolyzed infant formula is hypoallergenic.

Study Overview

• Status: Completed
• Conditions: Food Hypersensitivity
• Intervention / Treatment: Other: Extensively hydrolyzed, whey protein infant formula; Other: Extensively hydrolyzed, casein protein infant formula

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States
      • Little Rock Allergy & Asthma
  • California
    • Huntington Beach, California, United States
      • Pediatric Care Medical Group, Inc
    • Roseville, California, United States, 95678
      • Allergy Medical Group of the North Area
  • Georgia
    • Columbus, Georgia, United States
      • Brookstone Clinical Research Center
    • Savannah, Georgia, United States, 31406
      • Aeroallergy Research Labs of Savannah
  • Idaho
    • Eagle, Idaho, United States, 83616
      • Idaho Allergy and Asthma Specialists
  • Indiana
    • Evansville, Indiana, United States
      • Deaconness Clinic
  • New Jersey
    • Edison, New Jersey, United States
      • Anderson & Collins Clinical Research
  • New York
    • New York, New York, United States, 10029
      • Mount Sinai Faculty Practice Associates Pediatric Allergy
    • Newburgh, New York, United States
      • ENT & Allergy Associates
  • North Carolina
    • Asheville, North Carolina, United States, 28801
      • Allergy Partners of Western North Carolina
  • Texas
    • Boerne, Texas, United States
      • TTS Research
  • Virginia
    • Henrico, Virginia, United States
      • Clinical Research Partners
    • Vienna, Virginia, United States
      • Advanced Pediatrics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 months to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Born at term (>36 weeks gestation)
2. Two (2) months to ≤ 12 years of age at enrollment

3. Documented Cow's Milk Allergy (CMA) within the 6 months prior to enrollment by:

   1. Reported convincing allergic symptoms following an exposure to milk or a milk-containing food product and [detectable serum milk-specific IgE (>0.7 kIU/L) or positive skin prick test (wheal greater than 5 mm]), OR
   2. Physician-supervised oral food challenge that elicited immediate allergic symptoms, OR

   3. Results of laboratory tests highly predictive of clinical reactivity to milk

      • Serum milk IgE ≥15 [kIU/L]or ≥ 5 [kIU/L if younger than 1 year OR,
      • Skin prick tests mean wheal >10 mm
4. Otherwise healthy
5. If subject has asthma, atopic dermatitis, and/or rhinitis, must be well controlled
6. Expected daily intake of at least 8 oz (240 ml) of the study formula during the open challenge phase
7. Having obtained his/her legal representative's informed consent.

Exclusion Criteria:

1. Children consuming mother's milk at the time of inclusion and during the trial
2. Any chromosomal or major congenital anomalies
3. Any major gastrointestinal disease or abnormalities other than CMA
4. Chronic medical diseases (ie seizure disorders, chronic lung disease, heart problems (heart murmurs acceptable)
5. Immunodeficiency
6. Receiving free amino acid formula
7. Anti-histamine use in 7 days prior to the first food challenge (eyedrops are acceptable)
8. Oral steroid use within 14 days prior to enrollment (intranasal and topical corticosteroids are okay)
9. Unstable asthma
10. Severe uncontrolled eczema
11. Recent ( within the last 3 months) severe anaphylactic reaction to milk
12. Subject who in the Investigator's assessment cannot be expected to adhere to the study protocol
13. Currently participating in another clinical trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test Formula; New hydrolyzed whey formula	Other: Extensively hydrolyzed, whey protein infant formula; New hydrolyzed formula; Other Names: Baby Formula
Active Comparator: Control Formula; Commercially available hydrolyzed infant formula	Other: Extensively hydrolyzed, casein protein infant formula; Commercially available hydrolyzed infant formula; Other Names: Baby Formula

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hypoallergenicity	To demonstrate that the test formula does not provoke allergenic activity	14 Days

Secondary Outcome Measures

Outcome Measure	Time Frame
Digestive Tolerance	1 Week

Collaborators and Investigators

• Sponsor: Société des Produits Nestlé (SPN)
• Investigators: Principal Investigator: Anna Nowak-Wegrzyn, MD, Mount Sinai Department of Pediatrics; Study Director: Jose Saavedra, MD, Nestle Nutrition

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): August 1, 2012

Study Registration Dates

• First Submitted: January 14, 2011
• First Submitted That Met QC Criteria: January 14, 2011
• First Posted (Estimate): January 17, 2011

Study Record Updates

• Last Update Posted (Estimate): November 3, 2013
• Last Update Submitted That Met QC Criteria: November 1, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: CMA; Cow's Milk Allergy
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Food Hypersensitivity; Molecular Mechanisms of Pharmacological Action; Chelating Agents; Sequestering Agents; Caseins
• Other Study ID Numbers: 09.42.PED