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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cow's Milk Allergy
• Intervention / Treatment: Other: stool analysis , CBC, specific IgE FOR Cow milk protein allergy

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Hend A Saber, assistant lecturer; Phone Number: 01017590751; Email: hend011221@med.sohag.edu.eg
• Study Contact Backup: Name: Mohammed A Mohammed, professor

Study Locations

• Egypt
  • sOHAG, Egypt, Sohag
    • Recruiting
    • Sohag University Hospital
    • Contact: Magdy M Amin, Professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

males and females from birth up to five years 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).

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
patient who are diagnosed as cow milk protein allergy by CoMiss	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	one year
interpretation of the Cow's milk-related symptoms score	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.	one year
Food Challenge Test	positive or negative Food Challenge Test	one year

Collaborators and Investigators

• Sponsor: Sohag University

Publications and helpful links

General Publications

• Elieh Ali Komi D, Shafaghat F, Zwiener RD. Immunology of Bee Venom. Clin Rev Allergy Immunol. 2018 Jun;54(3):386-396. doi: 10.1007/s12016-017-8597-4.
• Aziz I, Simren M. The overlap between irritable bowel syndrome and organic gastrointestinal diseases. Lancet Gastroenterol Hepatol. 2021 Feb;6(2):139-148. doi: 10.1016/S2468-1253(20)30212-0. Epub 2020 Nov 13.
• Schoemaker AA, Sprikkelman AB, Grimshaw KE, Roberts G, Grabenhenrich L, Rosenfeld L, Siegert S, Dubakiene R, Rudzeviciene O, Reche M, Fiandor A, Papadopoulos NG, Malamitsi-Puchner A, Fiocchi A, Dahdah L, Sigurdardottir ST, Clausen M, Stanczyk-Przyluska A, Zeman K, Mills EN, McBride D, Keil T, Beyer K. Incidence and natural history of challenge-proven cow's milk allergy in European children--EuroPrevall birth cohort. Allergy. 2015 Aug;70(8):963-72. doi: 10.1111/all.12630. Epub 2015 May 18.
• Vandenplas Y, Mukherjee R, Dupont C, Eigenmann P, Host A, Kuitunen M, Ribes-Koninkx C, Shah N, Szajewska H, von Berg A, Heine RG, Zhao ZY; on behalf the Chinese CoMiSS Investigator Team.. Protocol for the validation of sensitivity and specificity of the Cow's Milk-related Symptom Score (CoMiSS) against open food challenge in a single-blinded, prospective, multicentre trial in infants. BMJ Open. 2018 May 17;8(5):e019968. doi: 10.1136/bmjopen-2017-019968.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Estimated): June 1, 2023
• Study Completion (Estimated): August 1, 2023

Study Registration Dates

• First Submitted: February 22, 2023
• First Submitted That Met QC Criteria: May 28, 2023
• First Posted (Actual): May 31, 2023

Study Record Updates

• Last Update Posted (Actual): May 31, 2023
• Last Update Submitted That Met QC Criteria: May 28, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Food Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Milk Hypersensitivity; Molecular Mechanisms of Pharmacological Action; Chelating Agents; Sequestering Agents; Caseins
• Other Study ID Numbers: Soh-Med-23-01-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No