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An Interventional Study of Milk Allergy and Tolerance in Children - NCT00778258-10029(Clinical Trial 249123)



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City:  New York
State:  
NY
Zip Code: 10029
Conditions: Food Hypersensitivity - Milk Hypersensitivity
Purpose: Milk is among the most common food allergens in infants and children. The majority of children outgrow their milk 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, some have been known to tolerate milk products cooked at high heat such as when baked in foods. The purpose of this study is to determine if children who are allergic to milk can increase tolerance through frequent dose-escalation every 6 months versus 12 months leading to eventual tolerance of less heated milk and ultimately unheated milk.
Study summary: In the United States, as many as 8% of children less than three years of age are affected by food hypersensitivity. 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 are data that suggest that the majority of children allergic to milk will tolerate heated milk products. Preliminary findings suggest that tolerance may be induced more quickly in those participants who ingest extensively heated, baked milk products. Therefore, a more rapid introduction of increasing doses of baked milk protein into the diet may result in accelerated development of tolerance to unheated milk. The purpose of this study is to determine whether more rapid introduction of increasingly allergenic forms of baked-milk products in baked-milk non-reactive participants shortens the time until they tolerate higher doses of less heated milk and ultimately unheated milk. The study will last up to 46 months for each study participant. There will be two Arms: Active Treatment Arm 1 and Comparison Arm 2. At study entry, all participants in Arm 1 will undergo sequential oral food challenges (OFCs) that contain increasing amounts of baked milk protein to determine the extent to which they tolerate various baked milk proteins. The participants tolerating baked milk will then be randomly assigned to one of two sub-arms that will receive treatment with various baked milk products. Group 1 participants who react to baked milk will continue strict milk avoidance and return for re-evaluation with baked milk challenge every 12 months until Month 36. Participants in Groups 2, 3, and 4 are tolerant to different forms of baked milk and will be randomized to return for re-evaluation every 6 or 12 months for dose escalation. In Arm 1, a review of clinical reactions, OFC, prick skin test, quality of life assessment, anthropometric measurements, mechanistic studies, and stool sample collection will occur at all study visits. Arm 2, the comparison group, will consist of participants who fulfill inclusion criteria, but have elected not to participate in the ingestion of baked milk products. Study visits will occur at months 12, 24, and 36. A review of clinical reactions, prick skin test, quality of life assessment, mechanistic studies, and stool sample collection will occur at all study visits. OFCs are optional for participants in Arm 2.
Criteria: Inclusion Criteria: - Suspected allergy to cow's milk - History of non-life threatening allergic reaction to milk or positive DBPCMC within 2 years prior to study entry or serum milk-IgE of high predictive value or milk prick skin test wheal of at least 10 mm within 6 months prior to study entry Exclusion Criteria: - Serum cow's milk specific IgE antibody greater than 35 kUA/L - History of life-threatening (grade 4) anaphylactic reaction to milk within 2 years prior to study entry - Unstable atopic disease such as asthma, atopic dermatitis, or allergic rhinitis within 7 days prior to study entry - Gastrointestinal eosinophilic disorders caused by milk - Use of short-acting antihistamines more than one time within 3 days prior to study entry - Use of medium-acting antihistamines more than one time within 7 days prior to study entry - Use of systemic steroids within 14 days prior to study entry - Maintenance therapy or use of beta-blockers and ACE inhibitors within 12-24 hours prior to study entry - Participation in any other trials of therapeutic interventions for food allergy - Therapy with anti-IgE for asthma within 1 year prior to study entry - Mental illness that, in the opinion of the investigator, would interfere with the study
Study is available at: Mount Sinai School of Medicine
New York, NY 10029
United States

Primary Contact:
Beth Robinson, RN
Email: Beth.robinson@mssm.edu
Phone: 212-241-0957
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: March 22, 2011
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