Extensively Hydrolyzed Formula: Hypoallergenicity

Nestlé

Status: Completed

Conditions: Food Hypersensitivity

Treatments: Other: Extensively hydrolyzed, casein protein infant formula; Other: Extensively hydrolyzed, whey protein infant formula

Study type: Interventional

Funder types: Industry

Identifiers

NCT01278446

09.42.PED

Details and patient eligibility

About

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

Sex: All

Ages: 2 months to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups

Test Formula

Experimental group

Description:

New hydrolyzed whey formula

Treatment:

Other: Extensively hydrolyzed, whey protein infant formula

Control Formula

Active Comparator group

Description:

Commercially available hydrolyzed infant formula

Treatment:

Other: Extensively hydrolyzed, casein protein infant formula