Clinical trial NCT02397876: Partially Hydrolyzed Whey Formula in Cow's Milk Allergic Patients
Official title: Partially Hydrolyzed Whey Formula in Cow's Milk Allergic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Food Allergy
Keywords: Food Allergy
Cows Milk Allergy
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: Société des Produits Nestlé (SPN)
First posted: 2015-03-25
Enrollment: 10
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Cow's milk (CM) allergy is the most common food allergy in children, affecting 2-3% of infants. In formula-fed infants with CM allergy, extensively hydrolyzed or amino acid-based infant formulas are typically recommended. These formulas are expensive and not palatable. For older patients with CM allergy, the standard of care is avoidance of all CM products. The investigators cared for a CM allergic patient who was able to tolerate partially hydrolyzed whey formula (pHWF), which tastes better and is less expensive than extensively hydrolyzed or amino-acid based formulas. There are likely other subjects who could similarly tolerate pHWF. Furthermore, it is possible that taking pHWF could accelerate tolerance of CM. The investigators aim to identify characteristics of CM allergic subjects who can tolerate pHWF and assess the degree to which taking pHWF accelerates CM tolerance.

Detailed description: Specifically, subjects who have CM allergy will be enrolled. The investigators will perform an oral food challenge (OFC) to pHWF in each subject. Subjects who pass the challenge will be placed on pHWF for 2 years. Subjects who do not pass the challenge will receive routine care. The investigators will perform allergy skin testing, specific IgE measurement, other serologic assays, and longitudinal OFCs to profile subject characteristics in the two groups at baseline and over time.

Eligibility criteria: Inclusion Criteria:

* age 0.5-18 years old
* positive skin prick tests (SPT) or detectable serum milk specific IgE and a history of an allergic reaction to milk within 6 months before study screening; or milk-specific IgE level or SPT highly predictive for clinical reactivity (if ≤ 2 years old, sIgE \>2 kU/L; if \> 2 years old, a level \>5 kU/L; SPT wheal diameter ≥ 3 mm)
* a clinical reaction during the cows milk oral food challenge

Exclusion Criteria:

* negative SPT and undetectable milk-specific sIgE
* unstable asthma, allergic rhinitis, or atopic dermatitis
* milk-induced eosinophilic gastroenteropathy
* recent reaction to partially hydrolyzed whey formula
* history of severe anaphylaxis with hypotension to cows milk
* participation in any interventional study for the treatment of food allergy in the 6 months prior to screening visit
* inhalant allergent immunotherapy that has not yet reached maintenance dosing
* inability to discontinue antihistamines for skin testing, OFC
* any systemic therapy which in the judgment of the investigator could be immunomodulatory in the 12 months prior to visit 1 (xolair, rituximab, chronic steroids, etc)
* investigational drug use 90 days prior to visit 1 or intention to use during study period
* the presence of any medical condition that the investigator deems incompatible with participation in the trial.
* unable to understand and speak English

Primary outcomes:
measure: Prevalence of partially hydrolyzed whey formula tolerance
timeFrame: Day 1
Secondary outcomes:
measure: Time to resolution of cows milk allergy
timeFrame: up to 2 years
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Supinda Bunyavanich, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wood RA, Sicherer SH, Vickery BP, Jones SM, Liu AH, Fleischer DM, Henning AK, Mayer L, Burks AW, Grishin A, Stablein D, Sampson HA. The natural history of milk allergy in an observational cohort. J Allergy Clin Immunol. 2013 Mar;131(3):805-12. doi: 10.1016/j.jaci.2012.10.060. Epub 2012 Dec 28.
citation: Jin YT. [Surgical treatment of post-traumatic enophthalmos (report of 5 cases)]. Zhonghua Zheng Xing Shao Shang Wai Ke Za Zhi. 1987 Sep;3(3):184-6, 238. No abstract available. Chinese.
citation: Reed RJ, Hairston MA, Palomeque FE. The histologic identity of adenoma sebaceum and solitary melanocytic angiofibroma. Dermatol Int. 1966 Jan-Mar;5(1):3-11. doi: 10.1111/j.1365-4362.1966.tb05174.x. No abstract available.
citation: Lee TD, Gimenez G, Grishina G, Mishoe M, Sampson HA, Bunyavanich S. Profile of a milk-allergic patient who tolerated partially hydrolyzed whey formula. J Allergy Clin Immunol Pract. 2015 Jan-Feb;3(1):116-8. doi: 10.1016/j.jaip.2014.06.021. Epub 2014 Aug 29. No abstract available.