Evaluation of Clinical Versus Home Introduction of Milk in Children with Non-IgE-mediated Cow's Milk Allergy ENIGMA Trial

What this Trial Is About

Researchers are investigating the best way to introduce cow's milk to infants suspected of having a non-IgE-mediated cow's milk allergy, which is a common food allergy in babies. The study aims to determine if cow's milk introduction should be done in a hospital setting or at home, as symptoms may be mild and overlap with other illnesses. This trial compares two methods to see which can identify if an infant can tolerate cow's milk without developing symptoms. Participants are randomly assigned to one of two groups: one group receives an adjusted double-blind placebo-controlled food challenge in the hospital over two days, where cow's milk and a look-alike placebo are given on separate days. The other group introduces cow's milk at home gradually, starting with small amounts and increasing to a full bottle. After testing, if cow's milk is tolerated, unrestricted consumption is advised; if not, parents follow a gradual "milk ladder" introduction. During the study, researchers will follow up regularly to check if the milk introduction is successful and to encourage continuation if needed. They will track the number of positive or negative test results, symptoms reported, milk consumption, and healthcare use over six weeks after the test. The main outcome is assessed one week after starting the test, with total participation lasting at least six weeks for ongoing monitoring and support.

Clinical Versus Home Introduction of Milk in Children with Non-IgE-mediated Cow's Milk Allergy