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Desensitisation Formula REgimens in Milk-Allergic Infants


Desensitisation Formula REgimens in Milk-Allergic Infants
Funding NIHR EME
Portfolio Paediatric, foetal and maternal health
Interventions Other
Randomised Yes
Status Funding awarded/in set-up
Start Date 01-Aug-2019

Cow’s milk allergy (CMA) affects around 2-7% of UK infants and is a leading cause of fatal allergic reactions in children. Although infants often outgrow cow’s milk allergy after 1-2 years, many remain allergic into mid-childhood and beyond. Parents have to strictly avoid giving their infants cow’s milk products, and special hypoallergenic milk formulas are needed where breastfeeding cannot continue.
Cow’s milk is important in a child’s diet, so avoidance is difficult and accidental reactions are common, including life-threatening anaphylaxis. Therefore, parents and doctors agree that better solutions are needed. The DREAM study will investigate a novel approach to managing CMA in infants. We will recruit 6-12-month-old infants with CMA and will free-feed them with either routine care “hypoallergenic” extensively-hydrolysed formula (eHF) or partially-hydrolysed formula (pHF). pHFs are currently used in infants with “colic”, and in some countries in healthy infants with a family history of allergy. Around 50-70% of infants with cow’s milk allergy will not react to pHF, because the milk proteins have been broken down, and they will be able to have this freely from the start. The remaining infants will be gradually desensitised to pHF by increasing the amount they eat, until they can have it freely as well.
We know that increasing exposure to the food a patient is allergic to, can help treat allergy. This is known as oral immunotherapy (OIT). We propose three important breakthroughs to this strategy: 1) targeting young (6-12-month-old) infants, when the immune system is more easy to manipulate; 2) free-feeding, in contrast to strict OIT dosing schedules; and 3) use of a formula with reduced ‘allergenicity’ (the ‘ability’ to cause reactions), to increase safety. We believe that this treatment will help infants outgrow CMA sooner, and will be safer and more cost-effective than current strategies At the start of the trial, we will use allergy tests to select cow’s milk-allergic infants who are less likely to outgrow their allergy naturally. Infants who can already tolerate pHF will be randomised to free feeding with either pHF or eHF (blinded feeding - the study team and families will not know which formula each infant is having). Infants who react to pHF will have oral immunotherapy (‘desensitization’) to either pHF or eHF, during which they will receive fixed doses; we expect that most
of them will eventually be able to be fed freely. At the end of the trial, all participants will undergo a ‘Double-Blind Placebo-Controlled Food Challenge’ to cow’s milk. This is the gold standard for diagnosis and will tell us if the infants have outgrown their allergy or not.


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