NCT00578656

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Jun 2004

Longer than P75 for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2004

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

December 19, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 21, 2007

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

August 1, 2012

Status Verified

July 1, 2012

Enrollment Period

6.7 years

First QC Date

December 19, 2007

Last Update Submit

July 30, 2012

Conditions

Food HypersensitivityMilk Hypersensitivity

Keywords

Food AllergyMilk Allergy

Outcome Measures

Primary Outcomes (1)

  • Tolerance to heated milk

    Throughout study

Secondary Outcomes (1)

  • Development of tolerance to non-heated milk

    Throughout study

Study Arms (1)

1

EXPERIMENTAL

Baked milk and at least 4 oral food challenges as clinically indicated

Dietary Supplement: Baked Milk

Interventions

Baked MilkDIETARY_SUPPLEMENT

Extensively heated milk

1

Eligibility Criteria

Age4 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mount Sinai School of Medicine

New York, New York, United States

Location

Related Publications (3)

  • 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. doi: 10.1016/j.jaci.2007.08.023. Epub 2007 Nov 1.

    PMID: 17935766BACKGROUND

  • 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. doi: 10.1111/j.1398-9995.2007.01501.x.

    PMID: 17919140BACKGROUND

  • Vandenplas Y, Koletzko S, Isolauri E, Hill D, Oranje AP, Brueton M, Staiano A, Dupont C. Guidelines for the diagnosis and management of cow's milk protein allergy in infants. Arch Dis Child. 2007 Oct;92(10):902-8. doi: 10.1136/adc.2006.110999.

    PMID: 17895338BACKGROUND

MeSH Terms

Conditions

Food HypersensitivityMilk Hypersensitivity

Condition Hierarchy (Ancestors)

Hypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Hugh A. Sampson, MD

    PRINCIPAL INVESTIGATOR

  • Scott H. Sicherer, MD

    PRINCIPAL INVESTIGATOR

  • Anna Nowak-Wegrzyn, MD

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2007

First Posted

December 21, 2007

Study Start

June 1, 2004

Primary Completion

February 1, 2011

Study Completion

February 1, 2011

Last Updated

August 1, 2012

Record last verified: 2012-07

Locations

US(1)