The Effect of Baked Milk on Cow's Milk Allergy

NCT02738060 | Completed Phase 2 DMC

• 1 other identifier: 9401359338
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

To investigate the effect of baked milk in immunotherapy of cow's milk allergy.

Conditions

Cow's Milk Allergy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Tolerance to cow's milk by measuring serum specific IgE levels

  1 month

• Tolerance to cow's milk using skin prick test

  1 month

• Tolerance to cow's milk by measuring serum IgG4

  1 month

Study Arms (1)

Case group

EXPERIMENTAL

The patients in case group will be received baked milk daily in the form of muffin for 6 months. They will be visited weekly in the first month and every 2 weeks in other 5 months. At the end of the 6 months, the patients will undergo oral food challenge by 30 grams baked cheese in the form of pizza cheese. If the test will be negative, they will receive pizza cheese 4 or 7 days per week for other 6 months. The patients will be followed every 2 weeks during this period.

Dietary Supplement: Baked Milk

Interventions

Baked Milk DIETARY_SUPPLEMENT

The patients in case group will be received baked milk daily in the form of muffin(30 cc milk (equal to 1/3 of milk's proteins) heated in 350 F or 180 C for 30 mints) for 6 months. They will be visited weekly in the first month and every 2 weeks in other 5 months. At the end of the 6 months, the patients will undergo oral food challenge by 30 grams baked cheese in the form of pizza cheese. If the test will be negative, they will receive pizza cheese 4 or 7 days per week for other 6 months. The patients will be followed every 2 weeks during this period. Skin prick test and serum IgE levels will be done at the beginning of the study, at 6 and 12 months. IgG4, being specific for milk allergens, will also measured at the beginning and at 12 months of the study.

Also known as: muffin, pizza cheese, baked milk products

Case group

Eligibility Criteria

• Age: 6 Months - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• The patients' ages between 6 months to 18 years old.
• Having positive histories of cow's milk allergy presenting by dermal, gastrointestinal, respiratory or systemic manifestations.
• 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.
• Cases who have tolerance to baked milk products confirmed by oral food challenge test.

You may not qualify if:

• Ones with low serum IgE levels and negative skin prick test for milk products.
• Ones with positive histories of unstable asthma.
• Ones with eosinophilic gastrointestinal disorders.
• Ones with history of allergy to baked milk products in last 6 months.
• Ones with positive history of severe anaphylactic reaction to milk and its products in last 6 months.
• Ones with positive allergy history to chicken egg or wheat.
• Patients with celiac disease.

Sponsors & Collaborators

• Hossein Esmaielzadeh: lead
• Shiraz University of Medical Sciences: collaborator

Study Sites (1)

Imam Reza Allergy and Immunology clinic, Shiraz University of Medical Sciences

Shiraz, Fars, 7186767431, Iran

Location

Related Publications (11)

• Sicherer SH, Sampson HA. Food allergy: recent advances in pathophysiology and treatment. Annu Rev Med. 2009;60:261-77. doi: 10.1146/annurev.med.60.042407.205711.

  PMID: 18729729 BACKGROUND

• 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. No abstract available.

  PMID: 21310308 BACKGROUND

• 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.

  PMID: 21236480 BACKGROUND

• 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.

  PMID: 18588554 BACKGROUND

• Jarvinen 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. doi: 10.1067/mai.2002.126080.

  PMID: 12170271 BACKGROUND

• Host 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. doi: 10.1111/j.1398-9995.1990.tb00944.x.

  PMID: 2288394 BACKGROUND

• 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.

  PMID: 19500710 BACKGROUND

• 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.

  PMID: 21601913 BACKGROUND

• 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.

  PMID: 18620743 BACKGROUND

• 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.

  PMID: 26839629 BACKGROUND

• Esmaeilzadeh H, Alyasin S, Haghighat M, Nabavizadeh H, Esmaeilzadeh E, Mosavat F. The effect of baked milk on accelerating unheated cow's milk tolerance: A control randomized clinical trial. Pediatr Allergy Immunol. 2018 Nov;29(7):747-753. doi: 10.1111/pai.12958. Epub 2018 Sep 12.

  PMID: 30027590 DERIVED

MeSH Terms

Conditions

Milk Hypersensitivity

Condition Hierarchy (Ancestors)

Food Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Hossein Esmaeilzadeh

  1.Allergy Research Center, Shiraz University of Medical Sciences, Shiraz, Iran. 2.Department of Allergy and Immunology, Namazi Hospital, Shiraz University of Medical Sciences, Shiraz, Iran

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assisstant Professor of Asthma and Allergy

Study Record Dates

• First Submitted: April 5, 2016
• First Posted: April 14, 2016
• Study Start: September 1, 2015
• Primary Completion: March 1, 2017
• Study Completion: April 1, 2017
• Last Updated: April 25, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)