The DREAM Study

A randomised controlled trial assessing Desensitisation to cow's milk, following partially or extensively hydrolysed formulae feeding REgimens, in children with Allergy to cow's Milk (The DREAM study).

Why are we doing this research?

Cow's milk allergy (CMA) is a response by the body in which proteins in cow's milk are recognised as a foreign substance and the immune system reacts to them by developing allergic symptoms. One type of CMA is caused by the immunoglobulin E antibody (called IgE). With this type of CMA, symptoms can appear within minutes of consuming cow's milk or up to two hours afterwards.

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 'Milk Ladder' is also supported, which involves slowly reintroducing processed milk and dairy products back into the baby's diet however, the Milk Ladder is not always suitable for all babies with cow's milk allergy.

Infants with cow's milk allergy who do not breast-feed, use an 'extensively hydrolysed milk formula' as their main diet. In this, the milk protein is broken down to very small bits, so that the infant does not react to it. However, these formulas are expensive, often have a bad taste and they do not help infants to overcome their allergy. The DREAM study will use a ‘partially hydrolysed milk formula', which means that the milk protein is still broken down but in larger bits. We predict that such a formula, which is cheaper and tastier, will also help infants to overcome their allergy sooner. Infants in the DREAM study will be given either one of these formula milks to be fed freely or will follow a strict schedule (oral immunotherapy), depending on how much they react to cow's milk.

The aim of the trial is to find out whether one year of feeding with a partially hydrolysed formula milk is more effective than feeding with an extensively hydrolysed formula milk, as a treatment for 6-12 month old infants with moderate-severe cow's milk allergy.

Who is the trial for?

DREAM is for 6-12 month old infants, with moderate-severe allergy to cow's milk.

What will the study involve?

To confirm that your child has an allergy to cow's milk, a blood test and skin test will be done by the clinical team at your local hospital. Your child will also be given some milk and the clinical team will monitor your child for any reactions; this is called a ‘milk challenge'. Once the allergy has been confirmed, your child will be given either partially hydrolysed formula or fully hydrolysed formula to be fed with as normal or in increasing amounts over the course of one year. After one year, the milk challenge will be repeated to see if your child has outgrown the milk allergy.

What are the benefits and risks of taking part?

The trial may be of benefit to participants with cow's milk allergy in overcoming their allergy quicker, and may contribute to new methods of treatment.

The procedures carried out in the DREAM trial will not put infants at any undue risk. All milk challenges will be medically supervised, and you will be given detailed advice regarding the formula to give at home. Advice and prescriptions will also be provided to you on how to manage potential allergic reactions to the formula.

How frequently will my child need to attend at the hospital?

The duration of the trial will be around one year. Some babies will only need to attend four times at the hospital. Some babies may need to attend up to six times in the year.

Are there any side-effects of this treatment?

No side effects have been shown by this special formula, which is already available for infants that are not allergic to milk. However, it is possible that allergic infants may react to the formula. These infants will be slowly desensitised through a special procedure (oral immunotherapy).

What will happen to the other treatments/foods that my child is receiving?

Your child will continue to receive all other treatments as normal. Weaning and feeding with other foods will also continue as you wish.

Recruiting Sites

Total Randomisations


Target Patients


Open Sites


Target Sites



NIHR - National Institute for Health Research logo
Manchester University NHS Foundation Trust logo
Liverpool Clinical Trials Centre logo
University of Liverpool logo
Anaphylaxis UK logo