Partially Hydrolyzed Whey Formula in Cow's Milk Allergic Patients
NCT ID: NCT02397876
Last Updated: 2016-12-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
10 participants
INTERVENTIONAL
2015-03-31
2016-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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partially hydrolyzed whey formula
The group of patients who pass an oral food challenge to partially hydrolyzed whey formula and will be continued on it through out the study
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.
No intervention
Patients who do not pass an oral food challenge to partially hydrolyzed whey formula will continue on their prior diet of cows milk avoidance.
No interventions assigned to this group
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
6 Months
18 Years
ALL
No
Sponsors
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Société des Produits Nestlé (SPN)
INDUSTRY
Icahn School of Medicine at Mount Sinai
OTHER
Responsible Party
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Principal Investigators
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Supinda Bunyavanich, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Locations
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Icahn School of Medicine at Mount Sinai
New York, New York, United States
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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GCO 14-2009
Identifier Type: -
Identifier Source: org_study_id