Cow’s milk allergy biomarker pilot (Chai 2)
Research type
Research Study
Full title
A pilot study to explore the feasibility of developing biomarkers for cow’s milk allergy in infancy
IRAS ID
344885
Contact name
Mich Erlewyn-Lajeunesse
Contact email
Sponsor organisation
University Hospitals Southampton NHS Foundation Trust
Duration of Study in the UK
5 years, 11 months, 30 days
Research summary
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.REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
25/EM/0089
Date of REC Opinion
1 May 2025
REC opinion
Further Information Favourable Opinion