Extensively Hydrolyzed Formula: Hypoallergenicity

NCT01278446 | Completed

• 1 other identifier: 09.42.PED
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 14

Brief Summary

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

Conditions

Food Hypersensitivity

Keywords

Cow's Milk Allergy; CMA

Outcome Measures

Primary Outcomes (1)

• Hypoallergenicity

  To demonstrate that the test formula does not provoke allergenic activity

  14 Days

Secondary Outcomes (1)

• Digestive Tolerance

  1 Week

Study Arms (2)

Test Formula

EXPERIMENTAL

New hydrolyzed whey formula

Other: Extensively hydrolyzed, whey protein infant formula

Control Formula

ACTIVE COMPARATOR

Commercially available hydrolyzed infant formula

Other: Extensively hydrolyzed, casein protein infant formula

Interventions

Extensively hydrolyzed, whey protein infant formula OTHER

New hydrolyzed formula

Also known as: Baby Formula

Test Formula

Extensively hydrolyzed, casein protein infant formula OTHER

Commercially available hydrolyzed infant formula

Also known as: Baby Formula

Control Formula

Eligibility Criteria

• Age: 2 Months - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Born at term (\>36 weeks gestation)
• Two (2) months to ≤ 12 years of age at enrollment
• Documented Cow's Milk Allergy (CMA) within the 6 months prior to enrollment by:
• 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
• Physician-supervised oral food challenge that elicited immediate allergic symptoms, OR
• 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
• Otherwise healthy
• If subject has asthma, atopic dermatitis, and/or rhinitis, must be well controlled
• Expected daily intake of at least 8 oz (240 ml) of the study formula during the open challenge phase
• Having obtained his/her legal representative's informed consent.

You may not qualify if:

• 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 acceptable)
• Immunodeficiency
• Receiving free amino acid formula
• Anti-histamine use in 7 days prior to the first food challenge (eyedrops are acceptable)
• Oral steroid use within 14 days prior to enrollment (intranasal and topical corticosteroids are okay)
• Unstable asthma
• Severe uncontrolled eczema
• Recent ( within the last 3 months) severe anaphylactic reaction to milk
• Subject who in the Investigator's assessment cannot be expected to adhere to the study protocol
• Currently participating in another clinical trial

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead

Study Sites (14)

Little Rock Allergy & Asthma

Little Rock, Arkansas, United States

Location

Pediatric Care Medical Group, Inc

Huntington Beach, California, United States

Location

Allergy Medical Group of the North Area

Roseville, California, 95678, United States

Location

Brookstone Clinical Research Center

Columbus, Georgia, United States

Location

Aeroallergy Research Labs of Savannah

Savannah, Georgia, 31406, United States

Location

Idaho Allergy and Asthma Specialists

Eagle, Idaho, 83616, United States

Location

Deaconness Clinic

Evansville, Indiana, United States

Location

Anderson & Collins Clinical Research

Edison, New Jersey, United States

Location

Mount Sinai Faculty Practice Associates Pediatric Allergy

New York, New York, 10029, United States

Location

ENT & Allergy Associates

Newburgh, New York, United States

Location

Allergy Partners of Western North Carolina

Asheville, North Carolina, 28801, United States

Location

TTS Research

Boerne, Texas, United States

Location

Clinical Research Partners

Henrico, Virginia, United States

Location

Advanced Pediatrics

Vienna, Virginia, United States

Location

MeSH Terms

Conditions

Food Hypersensitivity; Milk Hypersensitivity

Interventions

Infant Formula

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Milk Substitutes; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food, Formulated; Foods, Specialized; Food; Infant Food; Food and Beverages

Study Officials

• Jose Saavedra, MD

  Nestle Nutrition

  STUDY DIRECTOR

• Anna Nowak-Wegrzyn, MD

  Mount Sinai Department of Pediatrics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2011
• First Posted: January 17, 2011
• Study Start: February 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: August 1, 2012
• Last Updated: November 4, 2013

Record last verified: 2013-11

Locations

US (14)