Cow's Milk Allergy Clinical Trial
Official title:
Efficacy of Baked Milk in Accelerating Resolution of Cow's Milk Allergy
Verified date | April 2018 |
Source | Shiraz University of Medical Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To investigate the effect of baked milk in immunotherapy of cow's milk allergy.
Status | Completed |
Enrollment | 100 |
Est. completion date | April 2017 |
Est. primary completion date | March 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 6 Months to 18 Years |
Eligibility |
Inclusion Criteria: 1. The patients' ages between 6 months to 18 years old. 2. Having positive histories of cow's milk allergy presenting by dermal, gastrointestinal, respiratory or systemic manifestations. 3. Confirmed cow's milk allergy by standard diagnostic tools such as skin prick test more than 8 millimeters or serum IgE levels higher than 5 KIU/L up to 2 years old and 15 KIU/L in other ages. 4. Cases who have tolerance to baked milk products confirmed by oral food challenge test. Exclusion Criteria: 1. Ones with low serum IgE levels and negative skin prick test for milk products. 2. Ones with positive histories of unstable asthma. 3. Ones with eosinophilic gastrointestinal disorders. 4. Ones with history of allergy to baked milk products in last 6 months. 5. Ones with positive history of severe anaphylactic reaction to milk and its products in last 6 months. 6. Ones with positive allergy history to chicken egg or wheat. 7. Patients with celiac disease. |
Country | Name | City | State |
---|---|---|---|
Iran, Islamic Republic of | Imam Reza Allergy and Immunology clinic, Shiraz University of Medical Sciences | Shiraz | Fars |
Lead Sponsor | Collaborator |
---|---|
Hossein Esmaielzadeh | Shiraz University of Medical Sciences |
Iran, Islamic Republic of,
Boyce JA, Assa'ad A, Burks AW, Jones SM, Sampson HA, Wood RA, Plaut M, Cooper SF, Fenton MJ, Arshad SH, Bahna SL, Beck LA, Byrd-Bredbenner C, Camargo CA Jr, Eichenfield L, Furuta GT, Hanifin JM, Jones C, Kraft M, Levy BD, Lieberman P, Luccioli S, McCall KM, Schneider LC, Simon RA, Simons FE, Teach SJ, Yawn BP, Schwaninger JM. Guidelines for the diagnosis and management of food allergy in the United States: summary of the NIAID-sponsored expert panel report. Nutr Res. 2011 Jan;31(1):61-75. doi: 10.1016/j.nutres.2011.01.001. — View Citation
Dang TD, Peters RL, Allen KJ. Debates in allergy medicine: baked egg and milk do not accelerate tolerance to egg and milk. World Allergy Organ J. 2016 Jan 26;9:2. doi: 10.1186/s40413-015-0090-z. eCollection 2016. — View Citation
Høst A, Halken S. A prospective study of cow milk allergy in Danish infants during the first 3 years of life. Clinical course in relation to clinical and immunological type of hypersensitivity reaction. Allergy. 1990 Nov;45(8):587-96. — View Citation
Järvinen KM, Beyer K, Vila L, Chatchatee P, Busse PJ, Sampson HA. B-cell epitopes as a screening instrument for persistent cow's milk allergy. J Allergy Clin Immunol. 2002 Aug;110(2):293-7. — View Citation
Kim JS, Nowak-Wegrzyn A, Sicherer SH, Noone S, Moshier EL, Sampson HA. Dietary baked milk accelerates the resolution of cow's milk allergy in children. J Allergy Clin Immunol. 2011 Jul;128(1):125-131.e2. doi: 10.1016/j.jaci.2011.04.036. Epub 2011 May 23. — View Citation
Nowak-Wegrzyn A, Assa'ad AH, Bahna SL, Bock SA, Sicherer SH, Teuber SS; Adverse Reactions to Food Committee of American Academy of Allergy, Asthma & Immunology. Work Group report: oral food challenge testing. J Allergy Clin Immunol. 2009 Jun;123(6 Suppl):S365-83. doi: 10.1016/j.jaci.2009.03.042. — View Citation
Nowak-Wegrzyn A, Bloom KA, Sicherer SH, Shreffler WG, Noone S, Wanich N, Sampson HA. Tolerance to extensively heated milk in children with cow's milk allergy. J Allergy Clin Immunol. 2008 Aug;122(2):342-7, 347.e1-2. doi: 10.1016/j.jaci.2008.05.043. Epub 2008 Jul 11. — View Citation
Roth-Walter F, Berin MC, Arnaboldi P, Escalante CR, Dahan S, Rauch J, Jensen-Jarolim E, Mayer L. Pasteurization of milk proteins promotes allergic sensitization by enhancing uptake through Peyer's patches. Allergy. 2008 Jul;63(7):882-90. doi: 10.1111/j.1398-9995.2008.01673.x. — View Citation
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Sicherer SH. Epidemiology of food allergy. J Allergy Clin Immunol. 2011 Mar;127(3):594-602. doi: 10.1016/j.jaci.2010.11.044. Epub 2011 Jan 13. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Tolerance to cow's milk assessed by oral food challenge test | oral food challenge test is done for cow's milk products | 1 month | |
Secondary | Tolerance to cow's milk by measuring serum specific IgE levels | 1 month | ||
Secondary | Tolerance to cow's milk using skin prick test | 1 month | ||
Secondary | Tolerance to cow's milk by measuring serum IgG4 | 1 month |
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