Partially Hydrolyzed Whey Formula in Cow's Milk Allergic Patients

NCT02397876 | Completed

• 1 other identifier: GCO 14-2009
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Food Allergy

Keywords

Food Allergy; Cows Milk Allergy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Time to resolution of cows milk allergy

  up to 2 years

Study Arms (2)

partially hydrolyzed whey formula

EXPERIMENTAL

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

Other: Partially Hydrolyzed Whey formula

No intervention

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.

Interventions

Partially Hydrolyzed Whey formula OTHER

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.

Also known as: Gerber Good Start Formula

partially hydrolyzed whey formula

Eligibility Criteria

• Age: 6 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• Société des Produits Nestlé (SPN): collaborator

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Related Publications (4)

• 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.

  PMID: 23273958 BACKGROUND

• 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.

  PMID: 3151608 BACKGROUND

• 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.

  PMID: 4293047 BACKGROUND

• 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.

  PMID: 25577632 BACKGROUND

MeSH Terms

Conditions

Food Hypersensitivity; Milk Hypersensitivity

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Supinda Bunyavanich, MD, MPH

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2015
• First Posted: March 25, 2015
• Study Start: March 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: December 7, 2016

Record last verified: 2016-12

Locations

US (1)