DREAM
Research type
Research Study
Full title
A randomised controlled double-blind 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).
IRAS ID
279786
Contact name
Georgios Gkimpas
Contact email
Sponsor organisation
Manchester University NHS Foundation Trust
ISRCTN Number
ISRCTN37753699
Duration of Study in the UK
4 years, 7 months, 28 days
Research summary
Research Summary
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.
The DREAM trial will use a partially hydrolysed (pHF) milk formula, which means that the milk protein is partially broken down, and also a fully hydrolysed (eHF), milk formula. 206 infants aged 6-12 months will be given one of these milk formulas to be fed freely or will follow a strictly controlled schedule (oral immunotherapy). The hospital staff will not know who receives which formula.
After one year of feeding, the infants will take part in a ‘food challenge’ where they will be given a food that contains cow’s milk on one day and on a different day (either before or after), the same food will be given but it would not contain any cow’s milk (placebo), and they will be monitored for any allergic reactions. The hospital staff will not know which food contains cow’s milk. This is to determine whether one year of feeding with pHF milk is more effective than feeding with eHF milk in treating infants with moderate-severe CMA.
Summary of Results
Cow’s Milk Allergy (CMA) is one of the most frequent food allergies in infants. There is no known cure for CMA, and allergic infants need to avoid CM, feed with ‘hypoallergenic’ formulas (if not breastfeeding) and wait for the allergy to go away on its own. The only potentially helpful management is oral immunotherapy (OIT), where some infants eat very low regular doses of milk under close doctor follow-up. However, milk OIT is risky, and many reactions can occur, therefore it is not normally advised to patients. DREAM was designed to show whether using a particular formula (partially hydrolysed cow’s milk formula - pHF) would be safe for OIT.
Milk-Allergic infants aged 6-12 months were recruited and started to be fed on either extensively hydrolysed formula - eHF (safe formula used normally for allergic infants), or pHF. After a year of feeding, infants would be given cow’s milk at the hospital to see if they have managed to tolerate cow’s milk after having these formulas for a whole year. Unfortunately, the Trial was stopped early due to not managing to recruit as many infants as needed, and therefore no infant reached the end of the Trial.
Out of 16 infants which did enter the trial, fifteen (close to 94% of all infants), were able to have pHF with no major problems. These infants were shown through the trial’s tests to be very allergic to cow’s milk, therefore, being able to have pHF formula with little problem is very important.
The trial managed to show that pHF is promising for future OIT management, because many milk-allergic infants were able to feed on it. More research is needed to show if this formula can be used in the future to help infants grow out of their allergy.
REC name
London - Central Research Ethics Committee
REC reference
20/LO/1254
Date of REC Opinion
9 Feb 2021
REC opinion
Further Information Favourable Opinion