FARE-Supported Study Examines Wheat Oral Immunotherapy in Children and Young Adults

Wheat is a difficult food allergy to manage. While most children with wheat allergy outgrow it by age 12, one in three do not. Many individuals with wheat allergy have severe reaction symptoms. And this rich source of vegetable protein is everywhere – not just as a staple in baked goods and pastas, but also as a binding ingredient in sauces, soups, ice creams, processed meats, imitation seafood and more. Wheat can even pop up in non-food products, from play doughs and classroom crafts to cosmetics and medications.

With wheat so widely used and so hard to avoid, wheat allergy patients and their families are eager for effective treatments. FARE helped fund a multi-center clinical trial to investigate wheat oral immunotherapy (OIT), which has now been published online in the Journal of Allergy and Clinical Immunology. The study enrolled 46 participants, ages 4 to 22, who reacted to very small doses of wheat protein and had severe reaction symptoms.

One group consumed vital wheat gluten flour for two years, starting with very small daily amounts and escalating to a low maintenance dose of about 1.4 grams of wheat protein per day. The other group received placebo for one year before starting wheat OIT, which escalated to a high daily maintenance dose of about 2.7 grams of protein.

After the first year, more than half of the low-dose treatment group could tolerate a food challenge of about 4.4 grams of gluten, the amount of protein found in one to two slices of bread. In contrast, no one in the placebo group could tolerate the challenge dose.

Results after the second year showed that children and young adults who consumed a higher daily dose of gluten for one year were more likely to become desensitized than those who consumed a lower dose for two years. At the two-year mark, two-thirds of the high-dose group tolerated a 4.4-gram challenge dose, and more than half tolerated 7.4 grams of wheat protein, or roughly two to four slices of bread. In contrast, less than one-third of the low-dose participants could tolerate the 7.4-gram challenge after two years of treatment.

When the seven low-dose wheat OIT recipients who passed the 7.4-gram challenge avoided wheat for 8 to 10 weeks and then retested, only three of them – that is, 13 percent of the low-dose treatment group – showed sustained unresponsiveness, tolerating 7.4 grams of wheat protein after discontinuing daily maintenance doses.

Comparing this wheat OIT trial to an earlier trial of egg OIT, the authors indicate that the low-dose wheat OIT was less effective than OIT with a similar maintenance dose of egg white powder. Fewer wheat OIT participants tolerated larger challenge doses or were able to discontinue daily dosing and remain desensitized. In the egg study, 55 percent of participants on a maintenance dose of 1.5 grams of egg white protein daily could tolerate a 3.75-gram challenge after 10 months and 75 percent tolerated 6 grams of egg white protein after 22 months. By 24 months, 28 percent had achieved sustained unresponsiveness, successfully tolerating egg white protein and cooked egg after avoiding egg for 8 weeks.

Based on the number and severity of reactions during treatment, the study reports that the safety of wheat OIT is comparable to the safety of OIT for other foods. The authors conclude that wheat allergy may be less responsive than other food allergies to OIT, requiring higher maintenance doses and, possibly, longer courses of treatment.