NCT04684329

Brief 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 diagnosis of CMPA.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
84

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

December 21, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 24, 2020

Completed
8 days until next milestone

Study Start

First participant enrolled

January 1, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

December 24, 2020

Status Verified

December 1, 2020

Enrollment Period

1 year

First QC Date

December 21, 2020

Last Update Submit

December 21, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Sensitivity, specificity, and Overall accuracy value of sECP in CMPA.

    Sensitivity, specificity, and Overall accuracy value of sECP in CMPA.

    one year

Eligibility Criteria

AgeUp to 12 Months
Sexall
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

All infants (0-12 month) suspected with CMPA

You may qualify if:

  • \- All infants (0-12 month) suspected with CMPA

You may not qualify if:

  • Infants with genetic, metabolic, haematological, or infectious (e.g. :infectious gastroenteritis) diseases will be excluded from the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assuit university

Asyut, Assuit, Egypt

Location

MeSH Terms

Conditions

Milk Hypersensitivity

Condition Hierarchy (Ancestors)

Food HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Central Study Contacts

Ahmed abdelsalam mohamed

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
doctor

Study Record Dates

First Submitted

December 21, 2020

First Posted

December 24, 2020

Study Start

January 1, 2021

Primary Completion

January 1, 2022

Study Completion

March 1, 2022

Last Updated

December 24, 2020

Record last verified: 2020-12

Locations