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

NCT05883384 | Unknown

• 1 other identifier: Soh-Med-23-01-01
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Cow's Milk Allergy

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

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

Interventions

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

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

patient with cow milk protein allergy

Eligibility Criteria

• Age: 1 Minute - 5 Years
• Sex: all
• Age Groups: Child (0-17)
• 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).

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag University Hospital

Sohag, Sohag, Egypt

RECRUITING

Related Publications (4)

• 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.

  PMID: 28105558 BACKGROUND

• 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.

  PMID: 33189181 BACKGROUND

• 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.

  PMID: 25864712 BACKGROUND

• 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.

  PMID: 29773698 BACKGROUND

MeSH Terms

Conditions

Milk Hypersensitivity

Interventions

Occult Blood; Blood Cell Count

Condition Hierarchy (Ancestors)

Food Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Cell Count; Cytological Techniques; Hematologic Tests; Cell Physiological Phenomena; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Central Study Contacts

Hend A Saber, assistant lecturer

CONTACT

01017590751; hend011221@med.sohag.edu.eg

Mohammed A Mohammed, professor

CONTACT

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecture at pediatric department

Study Record Dates

• First Submitted: February 22, 2023
• First Posted: May 31, 2023
• Study Start: January 1, 2023
• Primary Completion: June 1, 2023
• Study Completion: August 1, 2023
• Last Updated: May 31, 2023

Record last verified: 2023-05

Locations

EG (1)