Clinical trial NCT05883384: Validity of Cow's Milk-related Symptom Score Among Children Suspected to Have Cow's Milk Protein Alergy
Official title: Validity of Cow's Milk-related Symptom Score Among Children Suspected to Have Cow's Milk Protein Allergy.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cow's Milk Allergy
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2023-05-31
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Observational model: OTHER
Time perspective: PROSPECTIVE
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).

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.


Eligibility criteria: 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.

Primary outcomes:
measure: patient who are diagnosed as cow milk protein allergy by CoMiss
timeFrame: one year
measure: interpretation of the Cow's milk-related symptoms score
timeFrame: one year
measure: Food Challenge Test
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: sOHAG
country: Egypt
facility: Sohag University Hospital
Study officials:
References:
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.
citation: 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.
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.
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.