Cow Milk Allergy Clinical Trial
Official title:
Assessment of Cow's Milk-related Symptom Scoring Awareness Tool in Young Turkish Children
In this study the investigators aimed to evaluate diagnostic accuracy the scoring tool used to determine cow's milk protein allergy, the cow's milk related symptom score, is based on the gastrointestinal, respiratory system and dermatological symptoms being together in young Turkish children.
Status | Recruiting |
Enrollment | 120 |
Est. completion date | December 25, 2017 |
Est. primary completion date | December 20, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 1 Year |
Eligibility |
Inclusion Criteria: - Reminding CMPA-respiratory system and dermatological symptoms and scoring over 12 in CoMISS. Exclusion Criteria: - Infants already fed with extensive hydrolyzed formula or amino aside based on formula. - Patients with a disease impairing normal gut transit, a known lactose intolerance severe chronic diarrhea, failure to thrive and neurological disease those that use antibiotics and those that have recently had surgical intervention or medical treatment. |
Country | Name | City | State |
---|---|---|---|
Turkey | The Children's Hospital Ankara University School of Medicine | Ankara |
Lead Sponsor | Collaborator |
---|---|
Ankara University |
Turkey,
Iacono G, Merolla R, D'Amico D, Bonci E, Cavataio F, Di Prima L, Scalici C, Indinnimeo L, Averna MR, Carroccio A; Paediatric Study Group on Gastrointestinal Symptoms in Infancy. Gastrointestinal symptoms in infancy: a population-based prospective study. Dig Liver Dis. 2005 Jun;37(6):432-8. Epub 2005 Mar 2. — View Citation
Koletzko S, Niggemann B, Arato A, Dias JA, Heuschkel R, Husby S, Mearin ML, Papadopoulou A, Ruemmele FM, Staiano A, Schäppi MG, Vandenplas Y; European Society of Pediatric Gastroenterology, Hepatology, and Nutrition. Diagnostic approach and management of cow's-milk protein allergy in infants and children: ESPGHAN GI Committee practical guidelines. J Pediatr Gastroenterol Nutr. 2012 Aug;55(2):221-9. doi: 10.1097/MPG.0b013e31825c9482. — View Citation
Lifschitz C, Szajewska H. Cow's milk allergy: evidence-based diagnosis and management for the practitioner. Eur J Pediatr. 2015 Feb;174(2):141-50. doi: 10.1007/s00431-014-2422-3. Epub 2014 Sep 26. Review. — View Citation
Piemontese P, Giannì ML, Braegger CP, Chirico G, Grüber C, Riedler J, Arslanoglu S, van Stuijvenberg M, Boehm G, Jelinek J, Roggero P; MIPS 1 Working Group. Tolerance and safety evaluation in a large cohort of healthy infants fed an innovative prebiotic formula: a randomized controlled trial. PLoS One. 2011;6(11):e28010. doi: 10.1371/journal.pone.0028010. Epub 2011 Nov 30. — View Citation
Vandenplas Y, Dupont C, Eigenmann P, Host A, Kuitunen M, Ribes-Koninckx C, Shah N, Shamir R, Staiano A, Szajewska H, Von Berg A. A workshop report on the development of the Cow's Milk-related Symptom Score awareness tool for young children. Acta Paediatr. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Efficacy of the cow's milk related symptom score | point change in cow's milk related symptom score within the 8 weeks follow-up period will be assess | 8 weeks |
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