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
|Condition or disease||Intervention/treatment||Phase|
|Food Hypersensitivity Milk Hypersensitivity||Dietary Supplement: Baked Milk||Early Phase 1|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||220 participants|
|Masking:||None (Open Label)|
|Official Title:||The Impact of the Diet Containing Limited Amounts of Processed Milk Protein on the Natural History of IgE-Mediated Milk Hypersensitivity|
|Study Start Date :||June 2004|
|Actual Primary Completion Date :||February 2011|
|Actual Study Completion Date :||February 2011|
Baked milk and at least 4 oral food challenges as clinically indicated
Dietary Supplement: Baked Milk
Extensively heated milk
- Tolerance to heated milk [ Time Frame: Throughout study ]
- Development of tolerance to non-heated milk [ Time Frame: Throughout study ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00578656
|United States, New York|
|Mount Sinai School of Medicine|
|New York, New York, United States|
|Principal Investigator:||Hugh A. Sampson, MD|
|Principal Investigator:||Scott H. Sicherer, MD|
|Principal Investigator:||Anna Nowak-Wegrzyn, MD|