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Majority of children outgrow their allergies, however there are two different methods to re-introduce milk products in the infant diet either direct milk intake in escalating doses or milk ladder, starting with baked milk products instead of pure milk.
This study aims to compare rate of tolerance after milk reintroduction among patient with cow milk protein allergy (CMPA) diagnosed by elimination re-challenge test after six months of elimination diet by milk ladder versus direct milk intake.
CMPA is an immunological response to one or more milk proteins. CMPA may be IgE mediated or Non-IgE mediated. It is one of the most frequent causes of food allergies in young children with an estimated prevalence between 1.9% and 4.9% in the first year of life.
CMPA has a good prognosis and cow milk is reintroduced in child diet. Natural history of CMPA shows heterogeneity and it is closely related to the clinical phenotype by which it was presented.
The timing and evaluation of developing tolerance is determined by clinical response to milk introduction.
When diagnosis of CMPA is confirmed, fresh pasteurized cow's milk can be used above 12 months of age in oral food challenge procedure, the starting dose should be lower than a dose that can induce a reaction and then increased step wise to 100ml, in children with mild to moderate reactions doses of 1ml, 3ml, 10ml, 30ml, and 100ml may be given at 30 minutes' intervals.
The milk ladder is an evidence-based plan to re-introduce milk products gradually and in stages for infants and children with mild to moderate cow's milk allergy, starting with food that contain only small amount of well-cooked milk and progressing towards uncooked dairy products and fresh milk. It's only started once child has been on a milk free diet for at least 6 months and they are completely well with no active eczema or gastro-intestinal symptoms.
Addition of baked- milk to the diet appears to accelerate the development of unheated-milk tolerance compared to strict avoidance, also its consumption is considered a form of immunotherapy with favorable safety, higher convenience, lower cost and less intensity when compared to oral immunotherapy. It's suggested to enhance the quality of life by removing unnecessary dietary restrictions and change the natural evaluation of milk allergy by promoting the development of tolerance to regular cow's milk.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients receiving direct milk antigen (Group A) | Active Comparator | Patients with cow milk protein allergy after 6 month of elimination diet will receive direct milk antigen and will be followed up for 2 months for the development of any symptoms of milk intolerance |
|
| Patients subjected to gradual reintroduction of milk through a milk ladder (Group B) | Active Comparator | Patient with cow milk protein allergy after 6 month of elimination diet will be offered indirect milk antigen through a ladder starting by baked milk products and will be followed up for also for 2 months to detect any symptoms of intolerance. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Direct Milk antigen reintroduction | Dietary Supplement | Direct milk antigen re-introduction milk according to ESPGHAN guidelines |
|
| Measure | Description | Time Frame |
|---|---|---|
| Compare the frequency of tolerance to milk between the two groups | Questionnaire done to assess occurrence of following symptoms Vomiting, Hematemesis, Diarrhea (using BRISTOL scale), Constipation, Eczema, Skin rash, Perianal inflammation, weight loss in kilograms or failure to gain weight in kilograms, (Colic, Straining and marked Abdominal distension), and recurrent respiratory symptoms within two months of following up after milk reintroduction. If any of the previous items is present, then the patient is considered intolerant to milk. All items should be answered by (no) in order to consider the patient tolerant to milk | intervention will be made six months of elimination diet, and follow up of 2 months later |
| Measure | Description | Time Frame |
|---|---|---|
| Recording of overall percentage of milk tolerance after 6 months elimination diet | the same questionnaire used to assess tolerance to milk products. Also all answers should be answered by No, otherwise patient would still be considered intolerant. | intervention will be made six months of elimination diet, and follow up of 2 months later |
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Inclusion Criteria:
Exclusion Criteria:
Patient with:
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| Name | Affiliation | Role |
|---|---|---|
| Ahmed Saber | AinShams University | Study Director |
| Yasmine El-Gendy | AinShams university | Study Director |
| Yosra Awad | Ain Shams University | Study Director |
| Nesreen Hammad | Ain Shams University | Study Director |
| Mostafa EL-Hodhod | Ain Shams University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain Shams University | Cairo | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12487206 | Result | Bahna SL. Cow's milk allergy versus cow milk intolerance. Ann Allergy Asthma Immunol. 2002 Dec;89(6 Suppl 1):56-60. doi: 10.1016/s1081-1206(10)62124-2. | |
| 21134576 | Result | NIAID-Sponsored Expert Panel; 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: report of the NIAID-sponsored expert panel. J Allergy Clin Immunol. 2010 Dec;126(6 Suppl):S1-58. doi: 10.1016/j.jaci.2010.10.007. |
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| ID | Term |
|---|---|
| D016269 | Milk Hypersensitivity |
| ID | Term |
|---|---|
| D005512 | Food Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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2 groups
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| Milk ladder | Dietary Supplement | B: Milk ladder according to the iMAP guideline which are 6 weeks of gradual reintroduction starting with baked milk not direct antigen |
|
| 30027590 | Result | 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. |
| 21134569 | Result | Fiocchi A, Schunemann HJ, Brozek J, Restani P, Beyer K, Troncone R, Martelli A, Terracciano L, Bahna SL, Rance F, Ebisawa M, Heine RG, Assa'ad A, Sampson H, Verduci E, Bouygue GR, Baena-Cagnani C, Canonica W, Lockey RF. Diagnosis and Rationale for Action Against Cow's Milk Allergy (DRACMA): a summary report. J Allergy Clin Immunol. 2010 Dec;126(6):1119-28.e12. doi: 10.1016/j.jaci.2010.10.011. |
| 21601913 | Result | 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. |
| 22569527 | Result | Koletzko S, Niggemann B, Arato A, Dias JA, Heuschkel R, Husby S, Mearin ML, Papadopoulou A, Ruemmele FM, Staiano A, Schappi 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. |
| 28516451 | Result | Lambert R, Grimshaw KEC, Ellis B, Jaitly J, Roberts G. Evidence that eating baked egg or milk influences egg or milk allergy resolution: a systematic review. Clin Exp Allergy. 2017 Jun;47(6):829-837. doi: 10.1111/cea.12940. Epub 2017 May 17. |
| 18158176 | Result | Longo G, Barbi E, Berti I, Meneghetti R, Pittalis A, Ronfani L, Ventura A. Specific oral tolerance induction in children with very severe cow's milk-induced reactions. J Allergy Clin Immunol. 2008 Feb;121(2):343-7. doi: 10.1016/j.jaci.2007.10.029. Epub 2007 Dec 26. |
| 24588904 | Result | Luyt D, Ball H, Makwana N, Green MR, Bravin K, Nasser SM, Clark AT; Standards of Care Committee (SOCC) of the British Society for Allergy and Clinical Immunology (BSACI). BSACI guideline for the diagnosis and management of cow's milk allergy. Clin Exp Allergy. 2014;44(5):642-72. doi: 10.1111/cea.12302. |
| 24450449 | Result | Nicolaou N, Tsabouri S, Priftis KN. Reintroduction of cow's milk in milk-allergic children. Endocr Metab Immune Disord Drug Targets. 2014 Mar;14(1):54-62. doi: 10.2174/1871530314666140121150228. |
| 18030203 | Result | Niggemann B, Beyer K. Diagnosis of food allergy in children: toward a standardization of food challenge. J Pediatr Gastroenterol Nutr. 2007 Oct;45(4):399-404. doi: 10.1097/MPG.0b013e318054b0c3. |
| 29516263 | Result | Upton J, Nowak-Wegrzyn A. The Impact of Baked Egg and Baked Milk Diets on IgE- and Non-IgE-Mediated Allergy. Clin Rev Allergy Immunol. 2018 Oct;55(2):118-138. doi: 10.1007/s12016-018-8669-0. |
| 17895338 | Result | Vandenplas Y, Koletzko S, Isolauri E, Hill D, Oranje AP, Brueton M, Staiano A, Dupont C. Guidelines for the diagnosis and management of cow's milk protein allergy in infants. Arch Dis Child. 2007 Oct;92(10):902-8. doi: 10.1136/adc.2006.110999. |
| 28852472 | Result | Venter C, Brown T, Meyer R, Walsh J, Shah N, Nowak-Wegrzyn A, Chen TX, Fleischer DM, Heine RG, Levin M, Vieira MC, Fox AT. Better recognition, diagnosis and management of non-IgE-mediated cow's milk allergy in infancy: iMAP-an international interpretation of the MAP (Milk Allergy in Primary Care) guideline. Clin Transl Allergy. 2017 Aug 23;7:26. doi: 10.1186/s13601-017-0162-y. eCollection 2017. |
| 30452099 | Result | Yang M, Tan M, Wu J, Chen Z, Long X, Zeng Y, Cai H, Zhang Y, Geng L, Xiao Y, Ke H, Liu Y, Rong L, Fu S, Wang H, Wang Y, Li X, Chen P, Li K, Xie J, Chen H, Li H, Wang H, Li DY, Gong S. Prevalence, Characteristics, and Outcome of Cow's Milk Protein Allergy in Chinese Infants: A Population-Based Survey. JPEN J Parenter Enteral Nutr. 2019 Aug;43(6):803-808. doi: 10.1002/jpen.1472. Epub 2018 Nov 19. |