CTRI Supports Pediatric Milk Allergy Study

Milk Study

Jonathan Nery (left) applies the first milk patch to the back of his son, Lucas, while his wife, Jill Dumbauld Nery and Rady Children’s nurse Kathryn Smith assist. (Photo by Carlos Delgado)

By Patti Wieser

Whether to participate in a clinical study can be a difficult decision. Making that choice for your child can be even more challenging.

“More thought goes into the decision because you are really making the choice for your child, who is too young to decide for himself,” said Jill Dumbauld Nery, MPH.

Jill Dumbauld Nery and Jonathan Nery have enrolled their 2-year-old son, Lucas, in a UC San Diego and Rady Children’s Hospital milk allergy study conducted by Stephanie Leonard, MD. From left are Jill, Lucas, and Jonathan.

 Nery, education manager at UC San Diego Clinical and Translational Research Institute (CTRI), and her husband, Jonathan Nery, recently enrolled their 2-year-old son, Lucas, in a milk allergy study at UC San Diego and Rady Children’s Hospital. The Nerys detected their son’s milk allergy when he was six months old after they expanded his diet of mother’s milk to include formula containing a small amount of cow’s milk. He broke out in hives and ended up in urgent care. They have experienced a couple of serious allergic incidents since the first one.

“Milk is one of the hardest foods to avoid because it is so prevalent. A majority of accidental reactions are triggered by milk. There’s a pat of butter here, a little bit of cheese there, or hidden whey protein in packaged goods,” said Stephanie Leonard, MD. “Sometimes people don’t realize what has milk in it. On average, food-allergic children experience at least one reaction per year and about 11 percent of them are severe.” Leonard, the principal investigator on the milk allergy study, said that’s why it’s so important to have therapies to protect children from accidental reactions. The two-year study will test how well the study drug, Viaskin Milk, works to decrease cow’s milk sensitivity in individuals with cow’s milk allergy. It began June 8 with Lucas as the first participant and will include about 10 participants, ranging in age from 2 to 17 at entry. DBV Technologies is sponsoring the randomized, placebo-controlled and double-blind study. CTRI registered dietician Cindy Knott is assisting with the food challenge parts of the study.

“We are enrolling patients in a milk patch immunotherapy trial designed to study the effectiveness of wearing a patch with milk protein on the skin to desensitize milk-allergic children,” Leonard said. “The goal is to prevent patients from having accidental reactions or to have only mild reactions if they accidentally ingested milk protein.”

Additional study subjects are needed.

While deciding on enrollment, the Nerys took into account the length of the study and the requirement of several visits to the study site at Rady Children’s Hospital-San Diego. Being proactive and taking a step before Lucas enters school tipped the scales in favor of enrollment. “Although many children outgrow milk allergies, it was not guaranteed to happen for Lucas. We wanted to be more proactive because Lucas has both milk and egg allergies,” Nery said. “It can be scary because if Lucas has a reaction we’re not sure how serious it will be. Once he goes to school, it will be tougher to know what he has been exposed to.”

Nery has been involved in helping recruit participants for studies, and she and her husband are both professionally well acquainted with clinical research, although she admits that a subjective point of view that involves your child is different from an objective one. “You want to make the best decision for your kid,” she said.

For the Nerys, they believe they have. And Nery acknowledged there is much uncertainty anyway for parents of children with allergies.

“The uncertainty of joining a clinical trial is not much different from the uncertainty of your kid having a reaction to something. In a trial, we are being monitored much more closely than we would otherwise,” she said.

If you are interested in enrolling your child in the study, please contact Dr. Leonard at (858) 966-5961, saleonard@ucsd.edu