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Baked Milk Clinical Research Trial

Elliot and Roslyn Jaffe Food Allergy Institute
Mount Sinai School of Medicine, New York, NY

Researchers headed by Drs. Hugh Sampson and Anna Nowak-Wegrzyn at the Mount Sinai Jaffe Food Allergy Institute in New York, NY are conducting a clinical trial for children with milk allergy, 4 through 10 years of age, who are willing to include baked-milk products such as muffins, pizza and rice pudding in their diet. The study involves visits every 6 to 12 months for up to 46 months.

The purpose of this research study is to see whether giving baked milk products more frequently, every 6 months, compared to every 12 months to children who tolerate baked-milk products shortens the time it may take them to tolerate higher doses of less heated form of milk, and ultimately regular milk. The researchers will also seek to explain possible changes in the immune system that may take place in the development of tolerance to milk.

The research study is sponsored by the National Institutes of Health. The study is approved by the Mount Sinai Institutional Review Board and is registered on www.Clinicaltrials.gov website; identifier NCT00778258.

Although the procedures done for study purposes are paid by the sponsor, participants will not receive further compensation for their participation in this study.

Detailed Description

In the United States, up to 8% of children less than three years of age 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 allergy, there are data suggesting that the majority may tolerate extensively heated milk products.  Initial findings in this study indicate that tolerance may be induced in those subjects who eat extensively baked-milk products. 

Arm 1: Qualifying and willing participants, in total 120 children in 5 subgroups.
The study will last up to 46 months for each study participant. At study entry, participants will undergo a number of 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 Active arm will have 5 subgroups.

Group 1 participants, who react to baked-milk products such as muffin, will continue strict milk avoidance and return for re-evaluation with baked-milk challenge after 12 months.

Depending on baked product the participant reacts to, he or she will be assigned to Groups 2, 3, or 4. The participant will be randomly (like a flip of a coin) assigned to return for re-evaluation every 6 or 12 months for dose escalation.

Participants who tolerate both baked and non-baked milk will be assigned to Group 5 and will be allowed to eat or drink milk without limitation and be re-evaluated at a scheduled time period.

In Arm 1, a review of clinical reactions, OFCs, prick skin test, quality of life assessment, mechanistic studies, and stool sample collection will occur at all study visits. Telephone follow-up assessments will occur in Groups 2, 3, 4, and 5.

Arm 2: Comparison group, in total 60 children will consist of participants who fulfill inclusion criteria, but have elected not to participate in the ingestion of baked products. Study visits will occur at on 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.

Inclusion Criteria:

• Age 4 through 10 years
• Suspected allergy to cow's milk who have a history of an allergic reaction to milk or positive food challenge within 2 years prior to study entry OR serum milk-IgE or prick skin test of high predictive value within 6 months prior to study entry

Exclusion Criteria:

• Serum cow's milk specific IgE antibody greater than 35 kU_A/L
• History of life-threatening anaphylactic reaction to milk within 2 years prior to study entry
• Gastrointestinal eosinophilic disorders caused by milk
• Participation in any other trials of therapeutic interventions for food allergy
• Therapy with anti-IgE for asthma within 1 year prior to study entry

Please contact the research coordinators working with this study with any questions:
Sally Noone: 212-241-0336; sally.noone@mssm.edu

[IRB approved through 6/23/09 GCO# 07-0563 aim 1; NIH ID# AADCRC-MSSM-02 ]