NCT04249973

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
81

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2018

Longer than P75 for all trials

Geographic Reach
1 country

8 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 26, 2018

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

January 23, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 31, 2020

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2025

Completed
Last Updated

April 12, 2024

Status Verified

April 1, 2024

Enrollment Period

7.2 years

First QC Date

January 23, 2020

Last Update Submit

April 11, 2024

Conditions

Cow Milk AllergyFood Allergy

Keywords

MetabolomicsMicrobiome analysis

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (4)

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

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

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

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

Interventions

Collection of urine and fecesOTHER

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

Healthy brothers and sistersIgE-mediated cow's milk allergyIgE-mediated food allergy, other than cow's milkSuspected of cow's milk allergy, but with negative diagnosis

Eligibility Criteria

AgeUp to 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • children of 5 years or older

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

AZ Sint-Jand

Bruges, Oost-Vlaanderen, 8000, Belgium

Location

AZ Sint Vincentius

Deinze, Oost-Vlaanderen, 9800, Belgium

Location

AZ Jan Palfijn

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

Ghent University Hospital

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

Maria Middelares

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

AZ Nikolaas

Sint-Niklaas, Oost-Vlaanderen, 9100, Belgium

Location

UZ Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location

ZNA Koningin Paola Kinderziekenhuis

Antwerp, 2020, Belgium

Location

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.

MeSH Terms

Conditions

Milk HypersensitivityFood Hypersensitivity

Interventions

Defecation

Condition Hierarchy (Ancestors)

Hypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Digestive System Physiological PhenomenaDigestive System and Oral Physiological Phenomena

Study Officials

  • Myriam Van Winckel, Prof

    University Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
4 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2020

First Posted

January 31, 2020

Study Start

January 26, 2018

Primary Completion

March 31, 2025

Study Completion

March 31, 2025

Last Updated

April 12, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared with other researchers

Locations

BE(8)