An Interventional Study of Milk Allergy - Full Text View

Sponsor:	National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by:	National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:	NCT00578656

Purpose

Milk is the among the most common food allergens in infants and children. The majority of children outgrow their allergies; however, the exact mechanisms by which food tolerance is achieved are unknown. Strict avoidance of the offending food is currently the only known therapy. However, subjects have been known to lose food hypersensitivity while frequently ingesting small amounts of processed forms of the offending product. The purpose of this study is to investigate whether ingestion of small amounts of processed milk protein will be permitted without compromising the chances of either outgrowing milk hypersensitivity or prolonging the time needed to achieve clinical tolerance.

Condition	Intervention	Phase
Food Hypersensitivity Milk Hypersensitivity	Dietary Supplement: Baked Milk Dietary Supplement: Baked milk placebo	Phase 0

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Parallel Assignment
Official Title:	The Impact of the Diet Containing Limited Amounts of Processed Milk Protein on the Natural History of IgE-Mediated Milk Hypersensitivity

Resource links provided by NLM:

MedlinePlus related topics: Allergy Dietary Supplements Diets Food Allergy

U.S. FDA Resources

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:

Tolerance to heated milk [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Development of tolerance to non-heated milk [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	220
Study Start Date:	June 2004
Estimated Study Completion Date:	November 2011
Estimated Primary Completion Date:	November 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Baked milk and at least 4 oral food challenges as clinically indicated	Dietary Supplement: Baked Milk Extensively heated milk
2: Placebo Comparator Placebo for baked milk and at least 4 oral food challenges as clinically indicated	Dietary Supplement: Baked milk placebo Milk placebo

Detailed Description:

In the United States, as many as 6% of children are affected by food allergy. Milk is among the most common food allergens in infants and children. Although strict avoidance of milk is the current standard of care for those with milk hypersensitivity, there is no conclusive evidence that absolute dietary restriction is necessary for achieving clinical tolerance. The purpose of this study is to determine whether ingestion of small amounts of extensively heated milk protein might be permitted without compromising the chances for ultimately losing milk hypersensitivity or prolonging the time needed to achieve clinical tolerance in a selected population of milk-allergic participants.

The study will last up to 48 months. The participants will be assigned to either Group 1 or Group 2. Group 1 will receive treatment with baked milk while Group 2 will act as the control and avoid milk consumption. This study will include dose escalation followed by oral food challenge (OFC).

Qualifying and willing participants will be assigned to Group 1, which will allow consumption of baked milk on a regular basis. Study visits will occur at Months 3, 6, 12, 18, 24, 30, 36, 42, and 48. Participants in Group 1 will be given an OFC using baked milk to identify desensitized individuals at Months 12, 24, 36, and 48.

Participants in Group 2 will be contacted by telephone every 6 months and asked about the current state of their milk allergy. Participants in this group will be asked to perform OFC at Months 12, 24, 36, and 48.

At each visit, medical history, physical exam, 7-day diet record, anthropometric measurements, and blood collection will occur. A pregnancy test will be performed at all visits for females of childbearing potential. A skin prick test will occur at most visits. Participants with atopic dermatitis will be assessed on the SCORAD scale at all visits.

Eligibility

Ages Eligible for Study:	4 Years to 25 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Positive prick skin test to milk and/or detectable serum milk-IgE
History of allergic reaction to milk within past 6 months
Serum milk-IgE of high predictive value (>15 in children older than 1 year, >5 in children younger than 1 year)
Asymptomatic or stabilized atopic disease (asthma, allergic rhinitis, atopic dermatitis) for a minimum of 7 days prior to OFC

Exclusion Criteria:

Serum level of cow's milk-specific IgE antibody greater than 35 kIU/L
History of anaphylactic reaction to cow's milk within the past 12 months
Unstable asthma
Allergic cosinophilic gastroenteritis caused by milk
Use of short-acting antihistamines more than one time within 3 days of OFC
Use of medium-acting antihistamines more than one time within 7 days of OFC
Maintenance therapy ot use of beta-blockers and ACE inhibitors within 12 to 24 hours of OFC
Participation in study baked egg study GCO#03-0609 within 6 months of enrollment
Pregnant

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00578656

Locations

United States, New York
Mount Sinai School of Medicine
New York, New York, United States

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

Principal Investigator:	Hugh A. Sampson, MD
Principal Investigator:	Scott H. Sicherer, MD
Principal Investigator:	Anna Nowak-Wegrzyn, MD

More Information

Publications:

Skripak JM, Matsui EC, Mudd K, Wood RA. The natural history of IgE-mediated cow's milk allergy. J Allergy Clin Immunol. 2007 Nov;120(5):1172-7. Epub 2007 Nov 1.

Staden U, Rolinck-Werninghaus C, Brewe F, Wahn U, Niggemann B, Beyer K. Specific oral tolerance induction in food allergy in children: efficacy and clinical patterns of reaction. Allergy. 2007 Nov;62(11):1261-9.

Vandenplas Y, Brueton M, Dupont C, Hill D, Isolauri E, Koletzko S, Oranje AP, Staiano A. Guidelines for the diagnosis and management of cow's milk protein allergy in infants. Arch Dis Child. 2007 Oct;92(10):902-8. Review. Erratum in: Arch Dis Child. 2007 Oct;92(10):following 908.

Responsible Party:	DAIT/NIAID ( Associate Director, Clinical Research Program )
Study ID Numbers:	DAIT P01 AI 144236, GCO#01-1209
Study First Received:	December 19, 2007
Last Updated:	February 24, 2009
ClinicalTrials.gov Identifier:	NCT00578656 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):

Food Allergy
Milk Allergy

Additional relevant MeSH terms:

Hypersensitivity
Food Hypersensitivity
Immune System Diseases
Milk Hypersensitivity
Hypersensitivity, Immediate

ClinicalTrials.gov processed this record on November 27, 2009