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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05883384
Other study ID # Soh-Med-23-01-01
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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.

Study Design


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
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