Cow Milk AllergyNCT04684329
Serum Esnophilic Cationic Protein Level as Diagnostic Marker in Cow Milk Protein Allergy Infants
An observational study of Cow Milk Allergy, run by Assiut University at 1 site in Egypt.
Trial summary
Characterize the degree of the activation of serum eosinophilc cationic protein (sECP) by measuring its level and establishing whether it is a useful parameter in monitoring oral cow's milk allergy Measure the MPV and NLR levels in infants with CMPA and to determine the suitability of these parameters as biomarkers in… Read more about this study
- Who is it for?
- Ages Up to 12 months
- Conditions the study is for
- Cow Milk Allergy
- How many people
- 84 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2021to Mar 2022
- 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 12 months
- All sexes
- Child
Study population: All infants (0-12 month) suspected with CMPA
Who may be able to join
- All infants (0-12 month) suspected with CMPA
Who cannot join
- Infants with genetic, metabolic, haematological, or infectious (e.g. :infectious gastroenteritis) diseases will be excluded from the study
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Assuit university
Asyut, Assuit
ahmed abdelsalam, master, 01005869830, ahmedfresh86@yahoo.com
About this study
Official title: the Value of Serum Esnophilic Cationic Protein as a Diagnostic Parameter in Infants With Cow Milk Protein Allergy
Characterize the degree of the activation of serum eosinophilc cationic protein (sECP) by measuring its level and establishing whether it is a useful parameter in monitoring oral cow's milk allergy Measure the MPV and NLR levels in infants with CMPA and to determine the suitability of these parameters as biomarkers in diagnosis of CMPA.
Read the detailed description
Cow's milk protein allergy (CMPA) is the most common cause of food allergies in children with incidence estimated as 2% to 7.5% in the first year of life and is characterized by an inflammatory reaction to milk proteins, Formula and exclusively breast-fed babies can develop CMPA.
The immunologic mechanism behind the development of CMPA is not yet clear. However, it is clear that CMPA is caused by IgE- as well as non-IgE-mediated immune reactions, IgE-mediated CMPA is better described and it is typically immediate, type 1 hypersensitivity (minutes to 2 hours after consumption of cow's milk) while non IgE- mediated CMPA is delayed, type 4 hypersensitivity. a diverse range of symptoms of variable intensity in infants.
Combinations of immediate and delayed reactions to the same allergen may occur in the same patient, symptoms and signs related to CMPA may involve many different organ systems, mostly the skin and the gastro- intestinal and respiratory tracts. The involvement of two systems increases the probability of CMPA, whereas some symptoms are more likely to be present in infant with a positive test for CMP-specific IgE (eg, angioedema, atopic eczema); however, there is a large overlap. The same symptoms may appear in CMP IgE-positive and IgE-negative patients, particularly in infant with gastrointestinal manifestations.
Studies in unselected infants with CMPA show that approximately half of them have atopic eczema, and 25% to 50% are affected by some gastrointestinal tract involvement whereas other clinical manifestations are less common.
It is important to accurately diagnose CMPA to avoid the consequences of either under- or overdiagnosis, skin prick test and serum specific IgE tests are helpful for diagnosis, mainly in IgE-mediated forms . On the other hand, in cases of CMPA with gastrointestinal chronic signs and symptoms, skin prick test and specific IgE tests are usually negative.
This is the reason why the only reliable method of diagnosis in such cases is a food challenge that need to be done in hospital and could be also dangerous, this explain why there is a growing interest to find new biomarkers for diagnosis and follow up.Eosinophil cationic protein (ECP) is a cytotoxic protein released from eosinophils upon activation the measurement of ECP levels can be used as a non invasive indicator to detect active inflammation in the body.
- Conditions
- Cow Milk Allergy
- Medical subject headings
- Milk Hypersensitivity
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity, specificity, and Overall accuracy value of sECP in CMPA.
Sensitivity, specificity, and Overall accuracy value of sECP in CMPA.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2020
- Study startJan 2021 (estimated)
- Primary completionJan 2022 (estimated)
- Study completionMar 2022 (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 Assiut UniversityThe 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 only
- Time perspective
- Prospective
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed abdelsalam mohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04684329
- Sponsor's protocol ID
- cow milk protein allergy
- Status last verified
- Dec 2020
- First submitted
- 21 Dec 2020
- Last updated
- 24 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Value of Serum Esnophilic Cationic Protein as a Diagnostic Parameter in Infants With Cow Milk Protein Allergy
- ClinicalTrials.gov ID
- NCT04684329
- Acronym / sponsor ID
- cow milk protein allergy
- Conditions
- Cow Milk Allergy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jan 2021 (estimated)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Mar 2022 (estimated)
- First posted
- 24 Dec 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.
Characterize the degree of the activation of serum eosinophilc cationic protein (sECP) by measuring its level and establishing whether it is a useful parameter in monitoring oral cow's milk allergy Measure the MPV and NLR levels in infants with CMPA and to determine the suitability of these parameters as biomarkers in diagnosis of CMPA.
Detailed description
Cow's milk protein allergy (CMPA) is the most common cause of food allergies in children with incidence estimated as 2% to 7.5% in the first year of life and is characterized by an inflammatory reaction to milk proteins, Formula and exclusively breast-fed babies can develop CMPA.
The immunologic mechanism behind the development of CMPA is not yet clear. However, it is clear that CMPA is caused by IgE- as well as non-IgE-mediated immune reactions, IgE-mediated CMPA is better described and it is typically immediate, type 1 hypersensitivity (minutes to 2 hours after consumption of cow's milk) while non IgE- mediated CMPA is delayed, type 4 hypersensitivity. a diverse range of symptoms of variable intensity in infants.
Combinations of immediate and delayed reactions to the same allergen may occur in the same patient, symptoms and signs related to CMPA may involve many different organ systems, mostly the skin and the gastro- intestinal and respiratory tracts. The involvement of two systems increases the probability of CMPA, whereas some symptoms are more likely to be present in infant with a positive test for CMP-specific IgE (eg, angioedema, atopic eczema); however, there is a large overlap. The same symptoms may appear in CMP IgE-positive and IgE-negative patients, particularly in infant with gastrointestinal manifestations.
Studies in unselected infants with CMPA show that approximately half of them have atopic eczema, and 25% to 50% are affected by some gastrointestinal tract involvement whereas other clinical manifestations are less common.
It is important to accurately diagnose CMPA to avoid the consequences of either under- or overdiagnosis, skin prick test and serum specific IgE tests are helpful for diagnosis, mainly in IgE-mediated forms . On the other hand, in cases of CMPA with gastrointestinal chronic signs and symptoms, skin prick test and specific IgE tests are usually negative.
This is the reason why the only reliable method of diagnosis in such cases is a food challenge that need to be done in hospital and could be also dangerous, this explain why there is a growing interest to find new biomarkers for diagnosis and follow up.Eosinophil cationic protein (ECP) is a cytotoxic protein released from eosinophils upon activation the measurement of ECP levels can be used as a non invasive indicator to detect active inflammation in the body.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 12 months
- Sex
- All
- Age groups
- Child
- Study population
- All infants (0-12 month) suspected with CMPA
Key inclusion criteria (1 listed)
- All infants (0-12 month) suspected with CMPA
Key exclusion criteria (1 listed)
- Infants with genetic, metabolic, haematological, or infectious (e.g. :infectious gastroenteritis) diseases will be excluded from the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sensitivity, specificity, and Overall accuracy value of sECP in CMPA.
Time frame: one year
Sensitivity, specificity, and Overall accuracy value of sECP in CMPA.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2020.
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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.
1 site 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, run by Assiut University at 1 site in Egypt.
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 1 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 24 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. 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?
Contact Ahmed abdelsalam mohamed (01005869830, ahmedfresh86@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity, specificity, and Overall accuracy value of sECP in CMPA. (time frame: one year). 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 24 Dec 2020.