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

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ClinicalTrials.gov Identifier: NCT04249973
Recruitment Status : Recruiting
First Posted : January 31, 2020
Last Update Posted : January 31, 2020
Sponsor:
Information provided by (Responsible Party):
University Ghent

Brief 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.


Condition or disease Intervention/treatment
Cow Milk Allergy Food Allergy Other: Collection of urine and feces

Detailed 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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 350 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 4 Years
Official Title: Detection of Metabolite Biomarkers for the Early Diagnosis and Prognosis of Cow's Milk Allergy in Children
Actual Study Start Date : January 26, 2018
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.
Other: Collection of urine and feces
Urine and feces are collected at the families home. A short questionnaire is filled in by the parents

Suspected of cow's milk allergy, but with negative diagnosis
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.
Other: Collection of urine and feces
Urine and feces are collected at the families home. A short questionnaire is filled in by the parents

IgE-mediated food allergy, other than cow's milk
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.
Other: Collection of urine and feces
Urine and feces are collected at the families home. A short questionnaire is filled in by the parents

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




Primary Outcome Measures :
  1. Metabolomics [ Time Frame: Samples will be analyzed in the beginning of 2020, the results are expected mid 2020 ]
    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.

  2. Microbiome analysis [ Time Frame: Samples will be analyzed mid 2020 ]
    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


Biospecimen Retention:   Samples Without DNA
Urine and fecal samples will be collected at the family's home. The majority of the patients will only be sampled once. But a small number of patients will be followed-up yearly for 3-4 years.


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
The cohorts will be selected from several hospitals in Flanders (UZ Ghent, AZ Jan Palfijn, AZ Maria Middelares, AZ Sint-Jan, Sint-Vincentius Deinze, UZ Leuven, AZ Nikolaas, ZNA Koningin Paola Children's Hospital.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04249973


Contacts
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Contact: Ellen De Paepe, MSc 0032 9 264 74 66 Ellen.DePaepe@UGent.be
Contact: Lynn Vanhaecke, Prof 0032 9 264 74 57 Lynn.Vanhaecke@UGent.be

Locations
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Belgium
AZ Sint-Jand Recruiting
Brugge, Oost-Vlaanderen, Belgium, 8000
Contact: Tania Claeys, Dr.    0032 50 45 27 40    Tania.Claeys@azsintjan.be   
AZ Sint Vincentius Recruiting
Deinze, Oost-Vlaanderen, Belgium, 9800
Contact: Anneleen Notebaert, Dr.       anneleen.notebaert@azstvdeinze.be   
AZ Jan Palfijn Recruiting
Gent, Oost-Vlaanderen, Belgium, 9000
Contact: Nele Baeck, Dr.       Nele.Baeck@janpalfijngent.be   
Maria Middelares Recruiting
Gent, Oost-Vlaanderen, Belgium, 9000
Contact: Kristien Kamoen, Dr.       Kristien.kamoen@azmmsj.be   
Ghent University Hospital Recruiting
Ghent, Oost-Vlaanderen, Belgium, 9000
Contact: Myriam Van Winckel, Prof    0032 9 332 24 30    Myriam.VanWinckel@UZGent.be   
AZ Nikolaas Recruiting
Sint-Niklaas, Oost-Vlaanderen, Belgium, 9100
Contact: Koen Vanlede, Dr.       Koen.Vanlede@aznikolaas.be   
UZ Leuven Recruiting
Leuven, Vlaams-Brabant, Belgium, 3000
Contact: Dominique Bullens, Prof.       Dominique.Bullens@kuleuven.be   
ZNA Koningin Paola Kinderziekenhuis Not yet recruiting
Antwerpen, Belgium, 2020
Contact: Ellen Peeters, Dr.       Ellen.Peeters@zna.be   
Sponsors and Collaborators
University Ghent
Investigators
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Principal Investigator: Myriam Van Winckel, Prof University Ghent
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Responsible Party: University Ghent
ClinicalTrials.gov Identifier: NCT04249973    
Other Study ID Numbers: B670201734666
First Posted: January 31, 2020    Key Record Dates
Last Update Posted: January 31, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual participant data will not be shared with other researchers

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Ghent:
Metabolomics
Microbiome analysis
Additional relevant MeSH terms:
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Hypersensitivity
Food Hypersensitivity
Milk Hypersensitivity
Immune System Diseases
Hypersensitivity, Immediate