Cow's Milk Allergy Clinical Trial
Official title:
Validity of Cow's Milk-related Symptom Score Among Children Suspected to Have Cow's Milk Protein Allergy.
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.
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. |
Country | Name | City | State |
---|---|---|---|
Egypt | Sohag University Hospital | sOHAG |
Lead Sponsor | Collaborator |
---|---|
Sohag University |
Egypt,
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
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02738060 -
The Effect of Baked Milk on Cow's Milk Allergy
|
Phase 2 | |
Recruiting |
NCT02149134 -
Evaluation of the Efficacy of a New Infant Formula in Subjects With Cow's Milk Allergy
|
Phase 2 | |
Recruiting |
NCT01891916 -
Effect Of Lactobacillus GG on Atopic March
|
N/A | |
Completed |
NCT01634490 -
Effects of Different Dietary Regimens on Tolerance Acquisition in Children With Cow's Milk Allergy
|
N/A | |
Completed |
NCT01622426 -
Tolerance to a New Free Amino Acid-based Formula in Children With IgE or Non-IgE-mediated Cow's Milk Allergy
|
N/A | |
Completed |
NCT02466035 -
Epigenetic Effects Involved in Children With Cow's Milk Allergy (EPICMA)
|
N/A | |
Completed |
NCT02379598 -
Effect of Therapy With Aminoacid Based Formula Versus Hydrolyzed Whey Proteins in Children With Cow's Milk Allergy
|
N/A | |
Completed |
NCT04330092 -
Diagnosis of Cow's Milk Protein Allergy
|
||
Not yet recruiting |
NCT02081651 -
Parmigiano-Reggiano Cheese as a Possible Strategy to Acquire Oral Tolerance in Children With Cow's Milk Allergy
|
Phase 3 | |
Completed |
NCT03462030 -
Baked Milk Oral Immunotherapy for Cow's Milk Allergy
|
Phase 2 | |
Completed |
NCT02465905 -
Oral Immunotherapy in Cow's Milk Allergy (CMA) in Children : "Petit Lait" Study
|
N/A | |
Suspended |
NCT05731206 -
Hypoallergenicity of a Hydrolyzed Protein Infant Formula
|
N/A | |
Not yet recruiting |
NCT06456541 -
Infant Formula in Infants and Children With Cow's Milk Allergy
|
N/A | |
Recruiting |
NCT02062476 -
Epigenetic Effects Elicited By Lactobacillus GG In Children With Cow's Milk Allergy
|
Phase 2 | |
Completed |
NCT01589731 -
Polymerized Beta-lactoglobulin Comparative Immunoreactivity
|
N/A | |
Terminated |
NCT02405923 -
Growth, Safety and Tolerance of a Rice Protein Hydrolysate Formula in Infants With Cow's Milk Protein Allergy
|
N/A | |
Terminated |
NCT04910373 -
Extensively Hydrolyzed Infant Formula in Infants and Children With Cow's Milk Allergy
|
N/A | |
Recruiting |
NCT01968278 -
Use of Baked Milk in Oral Immunotherapy for Severe IgE-mediated Cow's Milk Protein Allergic Patients
|
N/A | |
Withdrawn |
NCT01470768 -
Evaluation of Fatty Acid Levels and Growth in Infants Fed Amino Acid Based (AA) Formulas
|
N/A | |
Completed |
NCT01901380 -
Cow's Milk Allergy and Functional Gastrointestinal Disorders
|
N/A |