Validity of Cow's Milk-related Symptom Score Among Children Suspected to Have Cow's Milk Protein Alergy

Sponsor
Sohag University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05883384
Collaborator
(none)
100
1
7
14.4

Study Details

Study Description

Brief Summary

Cow's milk protein allergy is a sensitivity reaction against cow's milk protein and and is calcified as IgE-medaited, non- IgE mediated and mixed type according to the underlying immunological mechanism.

Cow's Milk related Symptom Score ( CoMiSS) Considers general manifestation and dermatological, gastrointestinal and respiratory symptoms.

Condition or Disease Intervention/Treatment Phase
  • Other: stool analysis , CBC, specific IgE FOR Cow milk protein allergy

Study Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Validity of Cow's Milk-related Symptom Score Among Children Suspected to Have Cow's Milk Protein Allergy.
Actual Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Aug 1, 2023

Arms and Interventions

Arm Intervention/Treatment
patient with cow milk protein allergy

apply CoMiSS on patient suspected to have cow milk protein allergy.

Other: stool analysis , CBC, specific IgE FOR Cow milk protein allergy
apply CoMiSS and food challenge test on patient whom suspected to have cow milk protein allergy.

Outcome Measures

Primary Outcome Measures

  1. patient who are diagnosed as cow milk protein allergy by CoMiss [one year]

    measure the accuracy percentage (%) of the Cow's milk-related symptoms score in diagnosis of cow milk allergy at pediatrics department in Sohag hospital university

  2. interpretation of the Cow's milk-related symptoms score [one year]

    The scoring ranges from 0 to 33. Each symptom has a maximal score of 6, except respiratory symptoms where the maximal score is 3. If final score > 12, the symptoms are likely cow's milk related. This could potentially be CMPA. If final score < 12, the symptoms are less likely related to cow's milk. Look for other causes. CMPA diagnosis can only be confirmed by an elimination diet followed by an oral food challenge.

  3. Food Challenge Test [one year]

    positive or negative Food Challenge Test

Eligibility Criteria

Criteria

Ages Eligible for Study:
1 Minute to 5 Years
Sexes Eligible for Study:
All
Inclusion criteria :
  • Age: from birth up to five years...

  • Sex: both Males and females

  • All children who suspected to have Cow's Milk Allergy that have the following symptoms (chronic unexplained failure to thrive, regurgitation , chronic abdominal distension, skin manifestation such as urticaria & eczema and respiratory symptoms such as chronic cough, recurrent wheezy chest).

Exclusion criteria

  • Functional GIT disorders such irritable bowel syndrome , Gastroesophageal reflux disease according to Rome IV criteria in children

  • Organic gastrointestinal diseases like coeliac disease , cystic fibrosis.

  • Chronic gastrointestinal infections as parasitic infections.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sohag University Hospital sOHAG Egypt Sohag

Sponsors and Collaborators

  • Sohag University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Hend Abdelrahim Saber, assistant lecture at pediatric department, Sohag University
ClinicalTrials.gov Identifier:
NCT05883384
Other Study ID Numbers:
  • Soh-Med-23-01-01
First Posted:
May 31, 2023
Last Update Posted:
May 31, 2023
Last Verified:
May 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 31, 2023