NCT03664076

Brief Summary

COMISS score for detection of Cow's Milk Protein Allergy in children with recurrent or persistent gastrointestinal manifistations in infants attending Assuit University Children Hospital

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2018

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

Study Start

First participant enrolled

September 1, 2018

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

September 7, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 10, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
Last Updated

September 10, 2018

Status Verified

September 1, 2018

Enrollment Period

1.1 years

First QC Date

September 7, 2018

Last Update Submit

September 7, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • COMISS score

    cow's milk protein symptos score

    one year

Interventions

COMISS scoreDIAGNOSTIC_TEST

cow's milk protein symptoms score awareness tool to select cow's milk protein allergy in infants

Eligibility Criteria

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

\- Infants of both sex. Age :less than one year attending Assiut university children hospital Persistent ( more than 15 days ) and recurrent ( according to ROM IV criteria ) gastrointestinal manifestations (vomiting, diarrhea, constipation, regurgitation or failure to thrive). Type of infant feeding: pure breast fed, artificially fed or mixed

You may qualify if:

  • Infants of both sex. Age :less than one year attending Assiut university children hospital Persistent ( more than 15 days ) and recurrent ( according to ROM IV criteria ) gastrointestinal manifestations (vomiting, diarrhea, constipation, regurgitation or failure to thrive).
  • Type of infant feeding: pure breast fed, artificially fed or mixed.

You may not qualify if:

  • Children older than one year. Infants with acute gastrointestinal manifestations. Previously diagnosed to have any gastrointestinal or systemic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Milk Hypersensitivity

Condition Hierarchy (Ancestors)

Food HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
internal resident

Study Record Dates

First Submitted

September 7, 2018

First Posted

September 10, 2018

Study Start

September 1, 2018

Primary Completion

October 1, 2019

Study Completion

November 1, 2019

Last Updated

September 10, 2018

Record last verified: 2018-09