USF seeks food allergy sufferers for new study

There are not a lot of recognized treatment options for people suffering from food allergies. They can avoid the offending food, take medication for reactions, or try some experimental remedies.

Last year things got easier for children ages 4 to 17 with peanut allergies. That’s when the U.S. Food and Drug Administration approved Palforzia®, a peanut protein developed in a trial that included the University of South Florida.

Now the university has begun screening potential candidates for a new clinical trial that ups the game: It treats multiple food allergies including tree nuts and seafood.

“We just don’t have much in the way of options [for food allergies], other than what we typically tell them. You’re going to have to try to avoid what you are allergic with and have an Epinephrine so you can treat yourself,” says Dr. Thomas Casale, the study’s principal investigator, who is a USF Professor of Medicine and Pediatrics.

Called the Harmony Study, the 15-allergen study includes peanuts, almonds, cashew, hazelnuts, pecans, pistachios, walnuts, codfish, salmon, shrimp, sesame seed, soy, wheat, milk and eggs, says Michelle Twitmyer, a clinical research coordinator for USF’s Asthma, Allergy and Immunology Clinical Research Unit.

“We don’t want somebody in the study who has more than five of those allergens,” Twitmyer says. “We want to make sure they are sensitive to at least one.”

In their medical practices, some physicians have been making their own egg powders or wheat powders to develop their own immunotherapy for food allergies, says Dr. Casale, chief medical advisor of the McLean-VA-based Food Allergy Research and Education organization.

“Shots [with allergens] are way too risky,” he says.

Participants in the study will be eating protein powders every day with the goal of building their tolerance and decreasing their odds of a severe reaction for an unplanned exposure. The amount will be increased after study participants demonstrate tolerance to the amount of protein they’ve been consuming.

The year-long study requires an investment of time, but it may give participants and their families increased peace of mind whenever they are inadvertently exposed to a food they are allergic to. 

The trial is open to participants ages 4 to 55. USF is looking to enroll four of the 72 participants in the 20-site, nationwide study.

The trial is sponsored by Alladapt Immunotherapeutics of Menlo Park, CA. Those interested in participating in the study should call 813-631-4024.

Another study planned soon, sponsored by the Swiss company Novartis, is aiming to discover if an injection of medication every two weeks is sufficient to block allergic reactions in people age 4 to 55, Twitmyer says.

Meanwhile USF has nine participants out of 20 in the groundbreaking peanut trial that led to the first FDA-approved peanut protein treatment for allergies. The European Commission also approved the product developed by Aimmune Therapeutics, Inc., a Nestlé Health Science Company.

The protein is used, instead of an actual peanut, because it offers a standardized dose, Twitmyer explains.

Related story: Allergic to peanuts? New protocol being tested at USF may make your life easier