An Interventional Study of Milk Allergy
Condition: Food Hypersensitivity; Milk Hypersensitivity
MeSH terms: Hypersensitivity; Milk Hypersensitivity; Food Hypersensitivity
Study type: Interventional
Phase: Early Phase 1

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.
    

Intervention name(s): Baked Milk
Intervention type(s): Dietary Supplement
Intervention description(s): Extensively heated milk
Allocation: Non-Randomized
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Food Allergy; Milk Allergy