The DREAM study is taking place at the Great North Children’s Hospital and aims to help babies overcome cow’s milk allergy
Cow’s milk allergy (CMA) can affect up to seven per cent of babies and is an allergic reaction to a protein in cow’s milk. Occasionally, CMA can cause severe symptoms, such as swelling in the mouth or throat, wheezing, coughing, difficulty breathing, and a fall in blood pressure leading to fainting.
CMA is one of the most common food allergies in infants, however, there is no standardised way to treat it. Current guidelines suggest complete avoidance of all products containing cow’s milk and waiting for the allergy to resolve spontaneously.
The DREAM study compares two different formulas: a hypoallergenic formula that is currently used for patients in normal clinical care, and another formula containing cows’ milk proteins that have been ‘partly’ broken down , which researchers believe may help babies overcome their allergy faster. Babies will be randomly allocated to receive one of the two feeding formulas
Research has shown that slowly giving patients increasing amounts of cow’s milk protein under strict doctor supervision might help them outgrow their allergy, however, increasing doses may be associated with causing allergic reactions, which requires strict doctor monitoring.
The formula used in this trial contains cow’s milk protein that is extensively broken down into small pieces to prevent reactions.
The study aims to recruit approximately 200 babies between six – twelve months-old, who have been diagnosed with CMA and prescribed hypoallergenic formula. The study is run by our paediatric research team out of the National Institute for Health and Care Research (NIHR) Clinical Research Facility, based at the RVI.
Helping babies overcome their allergy
Dr Louise Michaelis, co-chief investigator of the trial and honorary senior lecturer at Newcastle University, said: “Cow’s milk allergy is one of the most common food allergies in children and, while many eventually become tolerant, some remain allergic for many years.
“We hope that this study will help babies overcome their cow’s milk allergy at an earlier age. A formula, that contains modified cow’s milk protein, given every day in very small doses, will allow the body to ‘accept’ the cow’s milk protein rather than see it as a ‘stranger danger.”
Dr George Gkimpas, Co-Chief Investigator of the trial and Clinical Research Fellow at The University of Manchester said: “
“We know OIT can work under certain conditions, but it is usually reserved for children past their toddler years.
“In the DREAM trial we want to start this management early and include infants within their first year of life. This is a time when the immune system is more amenable, so the intervention has a better chance of being effective.
“DREAM’s approach to oral immunotherapy is innovative in that we are not using cow’s milk; therefore, we are not directly giving the babies the food that they are allergic to.
“Instead, we are using a modified, partially hydrolysed formula which we believe could help build immunity and could be safer than cow’s milk. Using this formula will allow many of our babies to be fed freely, which is another feature that makes this trial truly innovative.”
You can find out more about the DREAM study and how to take part on the study website.
- DREAM is funded by an award from the Efficacy and Mechanism Evaluation (EME) programme, a Medical Research Council and NIHR partnership.
- The study is sponsored by Manchester University NHS Foundation Trust