Unknown Digestion, Kidneys & Other Organs NIHR-supported project Pregnancy, Children & Inherited Conditions

A pilot study to explore the feasibility of developing biomarkers for cow’s milk allergy in infancy.

Funder NIHR (part of DHSC)
Recipient organisation NIHR Southampton Biomedical Research Centre
NIHR support Recorded as supported by this research centre
Period Mar 2025 — Ongoing

In plain English

AI plain-English summary

A baby with cow’s milk allergy currently has no way to confirm the diagnosis beyond a risky food challenge—feeding the allergen and waiting to see if they react. This pilot study aims to find a reliable biological marker, or biomarker, for cow’s milk allergy in infants. At the moment, diagnosis relies on clinical history, skin prick tests, and supervised food challenges, which can trigger severe allergic reactions. The researchers will take blood samples from infants with confirmed cow’s milk allergy and from age-matched controls, then isolate and study the T cells that respond to milk proteins. By comparing these immune cells before and after a carefully controlled reintroduction of dairy, they hope to identify specific patterns of cell activity—such as proliferation, cytokine release, or gene expression—that distinguish allergic from non-allergic infants. If this works, it could lead to a simple blood test that replaces the need for food challenges. That would make diagnosis safer, faster, and less distressing for families, and allow clinicians to tailor dietary advice with confidence. The work is at an early, feasibility stage, but it addresses a fundamental gap in paediatric allergy diagnostics.

View original technical description
A case control study to identify cow’s milk specific T cells from the peripheral blood of infants with Cow’s Milk Allergy (CMA) compared to an age matched comparison group. Infants with cow’s milk allergy will have clinical assessment and skin prick testing. Under medical supervision they will remove all dairy for 2-4 weeks and record daily baseline symptoms and food diary. They will return for a blood sample for PBMC to be drawn. Cow’s milk will be introduced according to risk of immediate or severe allergic reaction. Breastfeeding mothers will have the option to reintroduce dairy into the maternal diet to preserve breast milk exclusivity. All formula fed infants will have first dairy under hospital supervision with a food challenge protocol for those with positive skin prick tests or history of FPIES. Infants with a return of symptoms within 2 hours will resume a dairy free diet before they leave hospital. Otherwise, infants will reintroduce dairy at home until they have a return of symptoms. They will have daily access to a study helpline for clinical advice during home reintroduction. A further blood sample will be drawn once symptoms return. Samples will be processed on site at UHS. Lymphocytes will be cryopreserved, and plasma and breast milk frozen in aliquots, before shipment to La Jolla Institute for Immunology, (LJI, California, USA) for specific milk T cell proliferation, cytokines, mRNA studies. Analysis will compare CMA to aged matched controls. Difference will be sought between unstimulated and stimulated CMA samples. Milk allergic infants will be further categorised by the presence of IgE and the presence of immediate or delayed symptoms. Infants with FPIES will be compared to CMA and controls.

Researchers

Michel Erlewyn-Lajeunesse (Principal Investigator)

Related Research

Grants with similar aims, by meaning.

The feasibility of developing biomarkers for non-IgE mediated cow’s milk allergy
DREAM: 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
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).
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)
A prospective double blind randomised controlled study to evaluate the immunological benefits and clinical effects of an elimination diet using an amino acid formula (AAF) with an added preprobiotic blend in infants with Cow’s Milk Allergy (CMA).

Original classification

Respiratory and Allergy (RA)

Plain English summaries and category classifications on this site are generated by AI and may not perfectly reflect the original research.