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

Study Purpose

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 Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Unknown
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	1 Minute - 5 Years
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05883384
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Sohag University
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Egypt
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Cow's Milk Allergy

Arms & Interventions

Arms

: patient with cow milk protein allergy

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

Interventions

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Sohag University Hospital, sOHAG, Egypt

Status

Recruiting

Address

Sohag University Hospital

sOHAG, , Sohag

Site Contact

Magdy M Amin, professor

[email protected]

01017590751

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