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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational [Patient Registry]
Eligible Ages	N/A - 5 Years
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04249973
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University Ghent
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Myriam Van Winckel, Prof
Principal Investigator Affiliation	University Ghent
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Active, not recruiting
Countries	Belgium
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Cow Milk Allergy, Food Allergy

Additional Details

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.

Arms & Interventions

Arms

: IgE-mediated cow's milk allergy

Feces and urine samples are collected by the parents at home. Feces is collected out of the diaper or using a fecotainer. Urine is collected directly or using a urine collection pad. Additionally, the parents fill in a short questionnaire regarding the symptoms of their child, their clinical history and relevant information regarding the development of food allergies.

: Suspected of cow's milk allergy, but with negative diagnosis

: IgE-mediated food allergy, other than cow's milk

: Healthy brothers and sisters

Interventions

Other: - Collection of urine and feces

Urine and feces are collected at the families home. A short questionnaire is filled in by the parents

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

AZ Sint-Jand, Brugge, Oost-Vlaanderen, Belgium

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AZ Sint-Jand

Brugge, Oost-Vlaanderen, 8000

AZ Sint Vincentius, Deinze, Oost-Vlaanderen, Belgium

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AZ Sint Vincentius

Deinze, Oost-Vlaanderen, 9800

AZ Jan Palfijn, Gent, Oost-Vlaanderen, Belgium

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AZ Jan Palfijn

Gent, Oost-Vlaanderen, 9000

Maria Middelares, Gent, Oost-Vlaanderen, Belgium

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Maria Middelares

Gent, Oost-Vlaanderen, 9000

Ghent University Hospital, Ghent, Oost-Vlaanderen, Belgium

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Ghent University Hospital

Ghent, Oost-Vlaanderen, 9000

AZ Nikolaas, Sint-Niklaas, Oost-Vlaanderen, Belgium

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AZ Nikolaas

Sint-Niklaas, Oost-Vlaanderen, 9100

UZ Leuven, Leuven, Vlaams-Brabant, Belgium

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UZ Leuven

Leuven, Vlaams-Brabant, 3000

ZNA Koningin Paola Kinderziekenhuis, Antwerpen, Belgium

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ZNA Koningin Paola Kinderziekenhuis

Antwerpen, , 2020

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