Cow Milk AllergyNCT04249973
Detection of Metabolite Biomarkers for the Early Diagnosis and Prognosis of Cow's Milk Allergy in Children
An observational study of Cow Milk Allergy and Food Allergy, run by University Ghent at 8 sites in Belgium.
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… Read more about this study
- Who is it for?
- Ages Up to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Cow Milk Allergy, Food Allergy
- What is being tested?
- Collection of urine and feces
- How many people
- 81 participants
- Where
- 8 sitesBelgium
- Study dates
- 26 Jan 2018to 31 Mar 2025
- How long will I take part?
- 4 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 5 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- 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
Who cannot join
- children of 5 years or older
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Belgium8 sites
ZNA Koningin Paola Kinderziekenhuis
Antwerp, 2020
AZ Sint-Jand
Bruges, Oost-Vlaanderen, 8000
AZ Sint Vincentius
Deinze, Oost-Vlaanderen, 9800
AZ Jan Palfijn
Ghent, Oost-Vlaanderen, 9000
Ghent University Hospital
Ghent, Oost-Vlaanderen, 9000
Maria Middelares
Ghent, Oost-Vlaanderen, 9000
UZ Leuven
Leuven, Vlaams-Brabant, 3000
AZ Nikolaas
Sint-Niklaas, Oost-Vlaanderen, 9100
About this study
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.
Read the 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.
- Conditions
- Cow Milk Allergy, Food Allergy
- Being tested
- Collection of urine and feces
- Keywords
- Metabolomics, Microbiome analysis
- Medical subject headings
- Milk Hypersensitivity, Food Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of urine and fecesOther
Urine and feces are collected at the families home. A short questionnaire is filled in by the parents
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Collection of urine and feces | |
| 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. Receives: Other: Collection of urine and feces | |
| 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. Receives: Other: Collection of urine and feces | |
| 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. Receives: Other: Collection of urine and feces |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Samples will be analyzed in the beginning of 2020, the results are expected mid 2020
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
Measured: Samples will be analyzed mid 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2020
- Study start26 Jan 2018
- Primary completion31 Mar 2025 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cow Milk AllergyStudies of the same condition, open and under way.
- More trials run by University GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 81 participants (actual)
- Target duration
- 4 Years
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Myriam Van Winckel, Prof, Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04249973
- Sponsor's protocol ID
- B670201734666
- Status last verified
- Apr 2024
- First submitted
- 23 Jan 2020
- Last updated
- 12 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Metabolite Biomarkers for the Early Diagnosis and Prognosis of Cow's Milk Allergy in Children
- ClinicalTrials.gov ID
- NCT04249973
- Acronym / sponsor ID
- B670201734666
- Conditions
- Cow Milk Allergy, Food Allergy
- Keywords
- Metabolomics, Microbiome analysis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 81 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- 26 Jan 2018 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 31 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 4 Years
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| IgE-mediated cow's milk allergy | – | Other: Collection of urine and fecesFeces 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 | – | Other: Collection of urine and fecesFeces 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. |
| IgE-mediated food allergy, other than cow's milk | – | Other: Collection of urine and fecesFeces 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. |
| Healthy brothers and sisters | – | Other: Collection of urine and fecesFeces 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. |
Who may qualify
- Ages
- Up to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- children of 5 years or older
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collection of urine and fecesUrine and feces are collected at the families home. A short questionnaire is filled in by the parents | Other | Healthy brothers and sisters, IgE-mediated cow's milk allergy, IgE-mediated food allergy, other than cow's milk, Suspected of cow's milk allergy, but with negative diagnosis |
Primary outcome
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.
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2024.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Myriam Van Winckel, Prof principal investigator
University Ghent
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cow Milk Allergy and Food Allergy, run by University Ghent at 8 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metabolomics (time frame: Samples will be analyzed in the beginning of 2020, the results are expected mid 2020). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2024.