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

Cow's Milk Allergy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05883384
• Other study ID #: Soh-Med-23-01-01
• Status: Recruiting
• Start date: January 1, 2023
• Est. completion date: August 2023

Study information

• Verified date: May 2023
• Source: Sohag University
• Contact: Hend A Saber, assistant lecturer
• Phone: 01017590751
• Email: hend011221[@]med.sohag.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 2023
• Est. primary completion date: June 2023
• Gender: All
• Age group: 1 Minute to 5 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cow's Milk Allergy
• Hypersensitivity
• Milk Hypersensitivity

Intervention

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.

Locations

Country	Name	City	State
Egypt	Sohag University Hospital	sOHAG

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

References & Publications (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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Food Challenge Test	positive or negative Food Challenge Test	one year