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RecruitingNCT05883384Updated May 31, 2023

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

An observational study in Cow's Milk Allergy, sponsored by Sohag University. Recruiting at 1 site in Egypt. Open to participants aged 1 Minute to 5 Years. Per ClinicalTrials.gov, last updated 2023-05-31.

Sponsored by Sohag University · Observational

From the registry’s dates

  • Primary completion was expected by Jun 2023, 3 years 5 months ago, but the record still lists the study as recruiting.
  • Started Jan 2023; still recruiting 3 years 10 months later.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
100
Ages
1 Minute to 5 Years
Sex
All
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Study 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.

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Conditions studied

  • Cow's Milk Allergy

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03

In context

Milk Hypersensitivity

147 studies on the registry are indexed under Milk Hypersensitivity; 26 are open to participants now.

This study's planned enrollment of 100 is close to the median of 102 across 45 observational studies indexed under Milk Hypersensitivity.

Browse Milk Hypersensitivity studies →

Lead sponsor

Sohag University is the lead sponsor of 1,230 studies on the registry; 636 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
1 Minute to 5 Years
Sexes eligible
All
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).

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
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Study design

Observational model
Other
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • Otherstool 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.

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What researchers measure

Primary outcomes

  1. 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

    Time frame: one year

  2. 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.

    Time frame: one year

  3. Food Challenge Test

    positive or negative Food Challenge Test

    Time frame: one year

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Study locations

1 of 1 sites recruiting
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References and documents

Publications

  • 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. PubMed 28105558 ↗
  • 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. PubMed 33189181 ↗
  • 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. PubMed 25864712 ↗
  • 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. PubMed 29773698 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 31, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05883384
Lead sponsor
Sohag University
Responsible party
Hend Abdelrahim Saber (assistant lecture at pediatric department, Sohag University) — Principal investigator
First posted
May 31, 2023
Start date
Jan 1, 2023
Primary completion
Jun 2023 (estimated)
Completion
Aug 2023 (estimated)
Last update
May 31, 2023

Study contacts

Hend A Saber, assistant lecturer
Contact
hend011221@med.sohag.edu.eg
01017590751
Mohammed A Mohammed, professor
Contact

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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