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Trial record 1 of 1 for:    NCT00578656
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An Interventional Study of Milk Allergy

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ClinicalTrials.gov Identifier: NCT00578656
Recruitment Status : Completed
First Posted : December 21, 2007
Last Update Posted : August 1, 2012
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Tracking Information
First Submitted Date  ICMJE December 19, 2007
First Posted Date  ICMJE December 21, 2007
Last Update Posted Date August 1, 2012
Study Start Date  ICMJE June 2004
Actual Primary Completion Date February 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 19, 2007)
Tolerance to heated milk [ Time Frame: Throughout study ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00578656 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 19, 2007)
Development of tolerance to non-heated milk [ Time Frame: Throughout study ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Interventional Study of Milk Allergy
Official Title  ICMJE The Impact of the Diet Containing Limited Amounts of Processed Milk Protein on the Natural History of IgE-Mediated Milk Hypersensitivity
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Food Hypersensitivity
  • Milk Hypersensitivity
Intervention  ICMJE Dietary Supplement: Baked Milk
Extensively heated milk
Study Arms  ICMJE Experimental: 1
Baked milk and at least 4 oral food challenges as clinically indicated
Intervention: Dietary Supplement: Baked Milk
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 19, 2007)
220
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2011
Actual Primary Completion Date February 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 4 Years to 25 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00578656
Other Study ID Numbers  ICMJE DAIT P01 AI 144236
GCO#01-1209
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National Institute of Allergy and Infectious Diseases (NIAID)
Study Sponsor  ICMJE National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Hugh A. Sampson, MD
Principal Investigator: Scott H. Sicherer, MD
Principal Investigator: Anna Nowak-Wegrzyn, MD
PRS Account National Institute of Allergy and Infectious Diseases (NIAID)
Verification Date July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP