Partially Hydrolyzed Whey Formula in Cow's Milk Allergic Patients

Food Allergy Clinical Trial

Official title:

Partially Hydrolyzed Whey Formula in Cow's Milk Allergic Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02397876
• Other study ID #: GCO 14-2009
• Status: Completed
• Phase: N/A
• First received: March 19, 2015
• Last updated: December 6, 2016
• Start date: March 2015
• Est. completion date: June 2016

Study information

• Verified date: December 2016
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 18 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Food Allergy
• Food Hypersensitivity
• Hypersensitivity

Intervention

Other:
• Partially Hydrolyzed Whey formula
Patients who tolerate partially hydrolyzed whey formula will be continued on this formula for two years. Patients who do not tolerate the formula will be continued on their prior diet of cows milk avoidance.

Locations

Country	Name	City	State
United States	Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai	Nestlé

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. Chinese. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of partially hydrolyzed whey formula tolerance	Prevalence of partially hydrolyzed whey formula tolerance in cow's milk allergic patients - Identify patients who are cow's milk allergic but can tolerate a partially hydrolyzed whey formula	Day 1	No
Secondary	Time to resolution of cows milk allergy	Determine if ingestion of partially hydrolyzed whey formula accelerates the resolution of allergy to cow's milk.	up to 2 years	No