Cow's Milk AllergyNCT04330092
Diagnosis of Cow's Milk Protein Allergy
An observational study of Cow's Milk Allergy, run by Assiut University at 1 site in Egypt.
Trial summary
The study will assess the diagnosis of cow's milk protein allergy (CMPA) among infant and children in assiut university children hospital using skin prick test and specific serum IgE as well as their management. Read more about this study
- Who is it for?
- Ages 1 day to 2 years
- Conditions the study is for
- Cow's Milk Allergy
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2020to 1 Sep 2021
- 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 1 day to 2 years
- All sexes
- No healthy volunteers
- Child
Study population: the infant from 1st day to 2 years Exclusively breast feeding ,breast-fed infants with supplementary foods and non-breast fed infants with supplementary foods who complain from either frequent regurgitation, vomiting,diarrhea,constipation (with/without perianal rash) ,blood in stool or pallor.
Who may be able to join
- - Exclusively breast feeding ,breast-fed infants with supplementary foods and non-breast fed infants with supplementary foods who complain from either frequent regurgitation, vomiting,diarrhea,constipation (with/without perianal rash) ,blood in stool or pallor.
Who cannot join
- : Infant and child with gastrointestinal symptoms due to specific etiology.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diagnosis of Cow's Milk Protein Allergy Among Infants and Children in Assiut University Children Hospital
The study will assess the diagnosis of cow's milk protein allergy (CMPA) among infant and children in assiut university children hospital using skin prick test and specific serum IgE as well as their management.
Read the detailed description
Food allergy is a reproducible specific immune response to exposure to a given food. Cow's milk protein allergy (CMPA) is clinically abnormal reaction to cow's milk protein (CMP) via immune mechanisms triggered by milk protein (Boyce etal.,2010).
According to European academy for allergy and clinical immunology (EAACI) and the world allergy organization (wao) , a hypersensitivity reaction to cow's milk involving the immune system can be called as CMPA. There is difference between CMPA and non-allergic cow's milk intolerance (e.g lactose intolerance) which occurs as a result of lactase deficiency without involvement of the immune system (Venter etal.,2013).
CMPA is categorized into immunoglobulin IgE mediated , non -IgE mediated ,or mixed CMPA (Sicherer etal.,2001).
1.9% to 4.9% prevalence of CMPA among children with a peak in prevalence (2-3%) in the first year of life and prevalence of <1% in children aged >=6 years (koletzko etal.,2012).
- Conditions
- Cow's Milk Allergy
- Medical subject headings
- Milk Hypersensitivity
What is being measured
The primary outcome is the main question the study is designed to answer.
diagnosis of cow's protein allergy among infants and children from 1st day of life-2 years
compare between diagnosis by skin prick test and specific serum IgE
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2020
- Study start1 May 2020
- Primary completion1 Sep 2021
- Study completion1 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cow's 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Samir fawzy ali, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04330092
- Sponsor's protocol ID
- cow's milk allergy
- Status last verified
- Sep 2021
- First submitted
- 30 Mar 2020
- Last updated
- 16 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosis of Cow's Milk Protein Allergy Among Infants and Children in Assiut University Children Hospital
- ClinicalTrials.gov ID
- NCT04330092
- Acronym / sponsor ID
- cow's milk allergy
- Conditions
- Cow's Milk Allergy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 1 Apr 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.
The study will assess the diagnosis of cow's milk protein allergy (CMPA) among infant and children in assiut university children hospital using skin prick test and specific serum IgE as well as their management.
Detailed description
Food allergy is a reproducible specific immune response to exposure to a given food. Cow's milk protein allergy (CMPA) is clinically abnormal reaction to cow's milk protein (CMP) via immune mechanisms triggered by milk protein (Boyce etal.,2010).
According to European academy for allergy and clinical immunology (EAACI) and the world allergy organization (wao) , a hypersensitivity reaction to cow's milk involving the immune system can be called as CMPA. There is difference between CMPA and non-allergic cow's milk intolerance (e.g lactose intolerance) which occurs as a result of lactase deficiency without involvement of the immune system (Venter etal.,2013).
CMPA is categorized into immunoglobulin IgE mediated , non -IgE mediated ,or mixed CMPA (Sicherer etal.,2001).
1.9% to 4.9% prevalence of CMPA among children with a peak in prevalence (2-3%) in the first year of life and prevalence of <1% in children aged >=6 years (koletzko etal.,2012).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 day to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- the infant from 1st day to 2 years Exclusively breast feeding ,breast-fed infants with supplementary foods and non-breast fed infants with supplementary foods who complain from either frequent regurgitation, vomiting,diarrhea,constipation (with/without perianal rash) ,blood in stool or pallor.
Key inclusion criteria (1 listed)
- - Exclusively breast feeding ,breast-fed infants with supplementary foods and non-breast fed infants with supplementary foods who complain from either frequent regurgitation, vomiting,diarrhea,constipation (with/without perianal rash) ,blood in stool or pallor.
Key exclusion criteria (1 listed)
- : Infant and child with gastrointestinal symptoms due to specific etiology.
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
diagnosis of cow's protein allergy among infants and children from 1st day of life-2 years
Time frame: baseline
compare between diagnosis by skin prick test and specific serum IgE
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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's 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: finished, as of the sponsor's last update on 16 Sep 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
diagnosis of cow's protein allergy among infants and children from 1st day of life-2 years (time frame: baseline). 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 16 Sep 2021.