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

NCT ID: NCT05883384

Last Updated: 2023-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-01

Study Completion Date

2023-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cow's Milk Allergy

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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patient with cow milk protein allergy

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

stool analysis , CBC, specific IgE FOR Cow milk protein allergy

Intervention Type OTHER

apply CoMiSS and food challenge test on patient whom suspected to have cow milk protein allergy.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

1 Minute

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sohag University

OTHER

Sponsor Role lead

Responsible Party

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Hend Abdelrahim Saber

assistant lecture at pediatric department

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sohag University Hospital

Sohag, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Hend A Saber, assistant lecturer

Role: CONTACT

Phone: 01017590751

Email: [email protected]

Mohammed A Mohammed, professor

Role: CONTACT

Facility Contacts

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Magdy M Amin, professor

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 28105558 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33189181 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25864712 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29773698 (View on PubMed)

Other Identifiers

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Soh-Med-23-01-01

Identifier Type: -

Identifier Source: org_study_id