An Interventional Study of Milk Allergy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00578656
First received: December 19, 2007
Last updated: July 30, 2012
Last verified: July 2012
  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
Phase 0

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Masking: Open Label
Primary Purpose: Diagnostic
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:


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 ]

Enrollment: 220
Study Start Date: June 2004
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Baked milk and at least 4 oral food challenges as clinically indicated
Dietary Supplement: Baked Milk
Extensively heated milk

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. Based on the result of the oral food challenge with baked milk the participants will be assigned to either Group 1 (baked milk-tolerant) or Group 2 (baked milk-reactive). Participants in the Group 1 may be further tested with regular, non-heated milk, depending on their diagnostic test results and clinical history. Participants tolerant to non-heated milk will be discharged from the study. Baked milk-tolerant, non-heated milk-reactive participants in Group 1 will receive diet with baked milk at home while Group 2 will act as the control and avoid milk consumption strictly.

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 non-heated milk to identify tolerant 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 repeat OFC to baked milk at Months 12, 24, 36, and 48. Depending on the outcome of the repeat OFC, they may continue strict avoidance (if they reacted during baked milk OFC) or will be allowed to ingest baked milk in the diet (if they tolerated baked milk OFC).

At each visit, medical history, physical exam, 7-day diet record, anthropometric measurements, skin test and blood collection will occur. A pregnancy test will be performed at all visits requiring OFC 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 eosinophilic 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 or 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Publications:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00578656     History of Changes
Other Study ID Numbers: DAIT P01 AI 144236, GCO#01-1209
Study First Received: December 19, 2007
Last Updated: July 30, 2012
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:
Food Hypersensitivity
Hypersensitivity
Milk Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases

ClinicalTrials.gov processed this record on July 20, 2014