Extensively Hydrolyzed Formula: Hypoallergenicity

Not Applicable

Completed

• Conditions: Food Hypersensitivity
• Interventions: Other: Extensively hydrolyzed, whey protein infant formula; Other: Extensively hydrolyzed, casein protein infant formula

• Registration Number: NCT01278446
• Lead Sponsor: Société des Produits Nestlé (SPN)

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-01-14
• Study First Submitted QC: 2011-01-14
• Study First Posted: 2011-01-17
• Study Start: 2011-02
• Primary Completion: 2012-06
• Study Completion: 2012-08
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-01
• Last Update Posted: 2013-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Test Formula	Extensively hydrolyzed, whey protein infant formula	New hydrolyzed whey formula
Control Formula	Extensively hydrolyzed, casein protein infant formula	Commercially available hydrolyzed infant formula

Primary Outcome Measures

Name	Time	Method
Hypoallergenicity	14 Days	To demonstrate that the test formula does not provoke allergenic activity

Secondary Outcome Measures

Name	Time	Method
Digestive Tolerance	1 Week

Trial Locations

Locations (14)

Pediatric Care Medical Group, Inc; 🇺🇸 Huntington Beach, California, United States

Brookstone Clinical Research Center; 🇺🇸 Columbus, Georgia, United States

Aeroallergy Research Labs of Savannah; 🇺🇸 Savannah, Georgia, United States

Allergy Medical Group of the North Area; 🇺🇸 Roseville, California, United States

Allergy Partners of Western North Carolina; 🇺🇸 Asheville, North Carolina, United States

Deaconness Clinic; 🇺🇸 Evansville, Indiana, United States

Mount Sinai Faculty Practice Associates Pediatric Allergy; 🇺🇸 New York, New York, United States

Clinical Research Partners; 🇺🇸 Henrico, Virginia, United States

Little Rock Allergy & Asthma; 🇺🇸 Little Rock, Arkansas, United States

Advanced Pediatrics; 🇺🇸 Vienna, Virginia, United States

ENT & Allergy Associates; 🇺🇸 Newburgh, New York, United States

Anderson & Collins Clinical Research; 🇺🇸 Edison, New Jersey, United States

TTS Research; 🇺🇸 Boerne, Texas, United States

Idaho Allergy and Asthma Specialists; 🇺🇸 Eagle, Idaho, United States