NCT04330092

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2020

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 30, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 1, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

September 16, 2021

Status Verified

September 1, 2021

Enrollment Period

1.3 years

First QC Date

March 30, 2020

Last Update Submit

September 13, 2021

Conditions

Cow's Milk Allergy

Outcome Measures

Primary Outcomes (1)

  • 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

    baseline

Eligibility Criteria

Age1 Day - 2 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • \- 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.

You may not qualify if:

  • : Infant and child with gastrointestinal symptoms due to specific etiology.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assuit University

Asyut, Egypt

Location

MeSH Terms

Conditions

Milk Hypersensitivity

Condition Hierarchy (Ancestors)

Food HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
mohamed samir fawzy ali

Study Record Dates

First Submitted

March 30, 2020

First Posted

April 1, 2020

Study Start

May 1, 2020

Primary Completion

September 1, 2021

Study Completion

September 1, 2021

Last Updated

September 16, 2021

Record last verified: 2021-09

Locations

EG(1)