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

Food Allergy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04249973
• Other study ID #: B670201734666
• Status: Active, not recruiting
• Start date: January 26, 2018
• Est. completion date: March 31, 2025

Study information

• Verified date: April 2024
• Source: University Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 81
• Est. completion date: March 31, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 5 Years

Eligibility

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

Related Conditions & MeSH terms

• Cow Milk Allergy
• Food Allergy
• Food Hypersensitivity
• Hypersensitivity
• Milk Hypersensitivity

Intervention

Other:
• Collection of urine and feces
Urine and feces are collected at the families home. A short questionnaire is filled in by the parents

Locations

Country	Name	City	State
Belgium	ZNA Koningin Paola Kinderziekenhuis	Antwerpen
Belgium	AZ Sint-Jand	Brugge	Oost-Vlaanderen
Belgium	AZ Sint Vincentius	Deinze	Oost-Vlaanderen
Belgium	AZ Jan Palfijn	Gent	Oost-Vlaanderen
Belgium	Maria Middelares	Gent	Oost-Vlaanderen
Belgium	Ghent University Hospital	Ghent	Oost-Vlaanderen
Belgium	UZ Leuven	Leuven	Vlaams-Brabant
Belgium	AZ Nikolaas	Sint-Niklaas	Oost-Vlaanderen

Sponsors (1)

Lead Sponsor	Collaborator
University Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Metabolomics	Urine and fecal samples will be analyzed using a technique called metabolomics, which analyses all small molecules (metabolites) present in a biological fluid. These metabolites will be used to find biomarkers that are related to the disease and could have diagnostic or prognostic potential. Additionally, these metabolites could give more insights into the development and maintenance of the disease.	Samples will be analyzed in the beginning of 2020, the results are expected mid 2020
Primary	Microbiome analysis	The microbiomes of all groups will be analyzed because it has been described in literature that the microbiome can differ between healthy and allergic individuals. The microbial signatures related with IgE mediated CMA can give more insights into the pathology of the disease	Samples will be analyzed mid 2020