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.
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.
- 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
- 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
- Participation in study baked egg study GCO#03-0609 within 6 months of enrollment