Detection of Metabolite Biomarkers for the Early Diagnosis and Prognosis of Cow's Milk Allergy in Children

  • End date
    Dec 31, 2022
  • participants needed
  • sponsor
    University Ghent
Updated on 25 February 2022
early diagnosis
food allergy
milk allergy
allergy in children
Accepts healthy volunteers


In this study, fecal and urine samples will be collected from children diagnosed with :

  • IgE mediated cow's milk allergy,
  • suspected of a cow's milk allergy, but with negative diagnosis
  • IgE mediated food allergy other than cow's milk
  • healthy brothers and sisters of the first three groups A subset of patients with IgE-mediated cow's milk allergy will be asked to provide a urine and fecal sample yearly for prognostic purposes.

The samples will be analyzed using a technique called metabolomics to identify biomarker candidates with diagnostic and/or prognostic potential. Additionally, microbiome analysis will be performed to map the microbiome of all groups.


In this study urine and fecal samples will be collected from children until the age of 4 years old. The metabolome and microbiome of children with IgE mediated cow's milk allergy (1) (CMA) will be compared to that of children in three control groups: (2) children suspected of IgE mediated CMA, but with negative diagnosis, (3) children with an IgE mediated food allergy other than cow's milk and (4) healthy brothers and sisters of the first 3 groups. Children will be divided into these four groups based on the current diagnostic tests, including IgE measurements (skin prick tests and IgE measurements in venous blood samples), clinical history of the patients and their response to elimination diets. Samples will be collected shortly after diagnosis.

In a second phase of this study several patients will be followed up for several years (3 - 4 years), for which yearly a urine and fecal sample will be collected. Children included in this part will be younger than 1 year at the moment of their first sample donation, and diagnosed with IgE mediated CMA. This longitudinal follow-up is based on the microbial difference at the age between 3 to 6 months between children that will have a persistent allergy and the ones that will grow out of their allergy. These differences are anticipated to be translated in to the metabolomes of these children.

The samples will be collected at home and have to be frozen immediately after sample collection, after which they will be picked up by the researchers. The samples will be analyzed using a technique called metabolomics, using UHPLC-HRMS (Ultra-High Performance Liquid Chromatography coupled to High-Resolution Mass Spectrometry). After analysis the metabolic profiles of the different groups will be compared to each other using multivariate statistical analysis. This methodology will be applied to find biomarker candidates with good sensitivity and specificity for future CMA diagnosis or prognosis. Additionally, the identified biomarkers could provide more insights into the mechanisms behind the disease, which can aid in future therapy.

Microbiome analysis will be performed using qPCR and 16S rRNA sequencing.

Condition Cow Milk Allergy, Food Allergy
Treatment Collection of urine and feces
Clinical Study IdentifierNCT04249973
SponsorUniversity Ghent
Last Modified on25 February 2022


Yes No Not Sure

Inclusion Criteria

IgE mediated cow's milk allergy
suspected for a cow's milk allergy, but with negative diagnosis (e.g. non-IgE mediated cow's milk allergy)
IgE mediated food allergy other than cow's milk
healthy brothers and sisters from the first three groups

Exclusion Criteria

children of 5 years or older
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact



Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note