Microbiome and Immune profiling in infant with cow's milk allergy
Research type
Research Study
Full title
Profiling stool cytokines and microbiome of infants with non IgE mediated cow's milk protein allergy could explain its pathophysiology and be used as a non-invasive diagnostic method (Melina Study).
IRAS ID
236305
Contact name
George Raptis
Contact email
Sponsor organisation
NHS Greater Glasgow and Clyde
Duration of Study in the UK
3 years, 3 months, 19 days
Research summary
Cow’s Milk Protein Induced Enterocolitis (CMPIE) has the most dramatic presentation of the non-IgE-mediated food allergies. Associated exclusively with severe gastrointestinal symptoms, the cause of CMPIE is not yet fully understood, therefore limiting the identification of specific markers to help with the diagnosis.
Using a non-invasive method, the aim of this study is to identify new protein markers as well as to profile the bacteria (germs) released in stools of infants during the inflammatory process of this condition (acute and recovery phase).
The study group will include babies who are born at term by an uncomplicated birth and diagnosed with CMPIE in the first 3 months of life, while the control groups will consist of babies either healthy or with IgE or with other non-IgE-mediated Cow’s milk protein allergy (CMPA) or with non-allergic gastrointestinal inflammatory conditions (NAGIC). All groups will be matched for age, gender, type of feeding and mode of delivery.Stool, urine and blood samples (the latter only if already taken during the hospital admission in severe cases) will be collected at the acute and the recovery phase of this condition while the patient receives an appropriate hypoallergenic formula milk.
Protein markers, bacteria and their products will be measured in stool, urine and blood samples. These measurements will be carried out at the University of Glasgow, Human Nutrition Section labs at Glasgow Royal Infirmary and other University of Glasgow research labs as required.
The ultimate aim is to explore the potential role of these protein markers and bacteria in stool and if they can be used as non-invasive diagnostic tests. Further understanding of the disease cause may contribute to the development of new infant formula milk which may provide some gut protection.
REC name
North of Scotland Research Ethics Committee 1
REC reference
18/NS/0098
Date of REC Opinion
25 Sep 2018
REC opinion
Further Information Favourable Opinion