A new clinical trial run by paediatric teams at Newcastle Hospitals hopes to help babies overcome immunoglobulin (lg)E-mediated cow’s milk allergy.
CMA is one of the most common food allergies in infants under the age of one, but most children grow out of it. Common symptoms can include an itchy red rash, swelling of the lips or face, and in older children abdominal pain with vomiting. Severe symptoms can include difficulty in breathing with wheeze, known as anaphylaxis.
Treatment for CMA currently involves removing cow’s milk products from a child’s diet and in some case a mother’s diet. Breast feeding is fully supported and for those who choose to formula or combination feed a change to a hypoallergenic formula is advised.
These formulas contain varying amounts of broken down protein to prevent an allergic reaction but is not always effective in helping babies to overcome their allergy because they have an unpleasant taste and may be expensive.
To help babies build tolerance to cow’s milk and outgrow their allergy, a clinical trial called DREAM will use a formula which still contains broken down proteins, but into larger bits, known as partially hydrolysed.
Dr Louise Michaelis, consultant paediatrician in Immunology and Allergy at Newcastle Hospitals and co-lead for the DREAM trial, 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.
“In the DREAM study, we’ll compare the traditional hypoallergenic formula with the partially hydrolysed version, given in very small doses as a supplement (termed Oral Immunotherapy) and under the strict supervision of a doctor during a visit to the Great North Children’s Hospital.
“We hope that, by slowly increasing the dose, the body will learn to ‘accept’ the cow’s milk protein rather than see it as a threat.”
The study aims to recruit approximately 150 babies between six – twelve months-old who have been diagnosed with IgE mediated CMA.
These infants on the trial will be split into two different groups for the oral immunotherapy – one group will receive the traditional hydrolysed formula supplement, and the other will receive the partially hydrolysed version. This will help to compare whether one supplement is more effective than the other.
The study is run by Newcastle Hospitals’ paediatric research team out of the National Institute for Health and Care Research (NIHR) Clinical Research Facility, based at the Great North Children’s Hospital.
A short survey can be completed online to check if your child is suitable for the trial here.
- More information about the study is available here
- For more information about cow’s milk allergy, including symptoms of a severe reaction, visit the NHS website or Allergy UK
- 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
- Anaphylaxis UK are also involved in the trial
