Extensively Hydrolyzed Formula: Hypoallergenicity

Food Hypersensitivity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01278446
• Other study ID #: 09.42.PED
• Status: Completed
• Phase: N/A
• First received: January 14, 2011
• Last updated: November 1, 2013
• Start date: February 2011
• Est. completion date: August 2012

Study information

• Verified date: November 2013
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: August 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Months to 12 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Food Hypersensitivity
• Hypersensitivity

Intervention

Other:
• Extensively hydrolyzed, whey protein infant formula
New hydrolyzed formula
• Extensively hydrolyzed, casein protein infant formula
Commercially available hydrolyzed infant formula

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hypoallergenicity	To demonstrate that the test formula does not provoke allergenic activity	14 Days	Yes
Secondary	Digestive Tolerance		1 Week	No