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![The GINI Study—10 Year Analysis
2 key takeaway points from the
GINI study:
– Feeding with the pHF-W and eHF-
C formulas in the first 4 months has
a positive effect on cumulative
incidence of atopic
eczema/dermatitis in high-risk
children, lasting until 10 years
– However, feeding cow’s milk
protein hydrolysate formulas
compared with cow’s milk formula
has neither a positive effect on
asthma and allergic rhinitis nor
such an effect
on allergic sensitization
Physiciandiagnosedeczema[adj.%]
Adjusted cumulative incidence of parent-reported
physician-diagnosed eczema
45
40
35
30
25
20
15
10
9
8
7
6
0
1 2 3 4 5 6 7 8 9 10
Age [years]
pHF-W
eHF-C
eHF-W
CMF
CMF=standard cow’s milk formula; eHF-C=extensively hydrolyzed casein formula; eHF-W=extensively hydrolyzed whey formula; pHF-W=partially hydrolyzed whey formula.
Reprinted from J Allergy Clin Immunol. 2013;131(6):1565-1573. Von Berg A et al. Allergies in high-risk schoolchildren after early intervention with cow’s milk protein hydrolysates: 10-year
results from the German Infant Nutritional Intervention (GINI) study. ©2013, with permission from Elsevier.
Overall Study Conclusion: These results support the use of cow’s milk protein hydrolysate infant formula in high-risk infants to reduce the
risk for atopic eczema but not for respiratory allergies](https://image.slidesharecdn.com/cowmilkallergyksaad22-11-2019-200103153808/75/Cow-milk-allergy-36-2048.jpg)
Uploaded byKhaled Saad
Cow milk allergy
The document discusses cow's milk allergy (CMA) in infants, highlighting its prevalence, symptoms, and management strategies. It distinguishes between IgE-mediated and non-IgE-mediated reactions, providing clinical cases to illustrate symptoms and treatment approaches. Additionally, the document outlines dietary interventions and studies that assess the impact of infant formula on allergies, particularly the use of hydrolyzed formulas for at-risk children.
In this document
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Introduction to the topic of Cow Milk Allergy (CMA) presented by Professor Khaled Saad.
Differentiating IgE and non-IgE responses and reviewing clinical effects of hydrolyzed formulas.
Two infant cases illustrating symptoms of CMA such as irritability, spitting up, and poor growth.
Nutritional composition of human milk focusing on carbohydrates, lipids, proteins, and immune properties.
CMA affects 2-6% of infants, with details on symptoms and historical dietary context.
Classification of food reactions, including IgE and non-IgE mediated allergies, and their economic impact.
Overview of diagnostic approaches and distinguishing features between IgE-mediated and non-IgE reactions.
Comparison between CMA as an allergic reaction to milk protein and lactose intolerance.
Examines contributing factors to rising food allergies, including dietary changes and hygiene hypothesis.
Discussion of CMA symptoms that resemble gastroesophageal reflux disease in infants.
Importance of thorough history and specific IgE tests in diagnosing CMA.
Current strategies in managing food allergies primarily via avoidance and pharmacotherapy.
Findings from the GINI study on the effect of hydrolysate formulas on allergy incidence.
Best practices for feeding high-risk infants include breastfeeding recommendations and formula options.
Encourages proactive measures against allergies and emphasizes the role of breastfeeding.
Best practices for feeding high-risk infants include breastfeeding recommendations and formula options.
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Cow milk allergy
- 2.
- 3. COW MILK ALLERGY 22-11-2019 KhaledSaad Professor of pediatrics
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- 5. Objectives Distinguish IgEand non-IgE mediated aspects of cow’s milk allergy (CMA) Review the clinical effects of extensively hydrolyzed formula in infants with CMA
- 6. A Case Vital StatsGirl 3months old Length 50th percentile Weight 40th percentile Reason for visit • Spitting up and irritability CMA-related symptoms • Spitting up large volumes, irritability, seborrhea Other medical history/ family history • None Current formula • AR formula Feeding history • Breastmilk for 1 month, cow’s milk formula thereafter Medications • Proton pump inhibitor Birth history • Uncomplicated term delivery Other considerations • Normal bowel movements
- 7. Vital Stats Boy 4 months old Length 30th percentile Weight3rd percentile Another Case Reason for visit • Ongoing blood and mucus in stools History • Poor growth CMA-related symptoms • Loose stools, mucus in stools, blood streaks in stools, poor weight gain Other medical history/ family history • Older sister: allergy to egg • Mother: asthma Current formula • Intact cow’s milk–based, lactose-free formula Feeding history • Began on routine formula, • Then switched to intact cow’s milk–based, lactose-free formula Medications • Simethicone Birth history • Uncomplicated term delivery Other considerations • Gassiness t.
- 8. NUTRITIONAL VALUES CARBOHYDRATES Humanmilk carbohydrate is comprised principally of lactose, with a small proportion consisting of oligosaccharides. Oligosaccharides are important in the host defense of the infant as their structures mimic specific bacterial antigen receptors.
- 9. LIPIDS Represents approximately50 % of the calorie intake. Fatty acids in human milk consist of a high proportion of long-chain fatty acids: palmitic, oleic, and the essential fatty acids: linoleic, and linolenic.
- 10. Approximately 70% of the proteins in human milk are in the soluble whey and 30 % insoluble casein. Whey is easily digested and is associated with more rapid gastric emptying. The major human whey protein is alpha- lactalbumin while the major bovine whey protein is beta-lactoglobulin, which may contribute to protein allergy and colic. PROTEINS
- 11. • Human breastmilk contains immunoglobulins, antimicrobial enzymes. It also contains anti- inflammatory and tolerance-promoting compounds, such as I L 10. • Exclusive breastfeeding for at least 3 to 4 months of age is associated with a reduced risk of atopy and lowered incidence of recurrent wheezing during the first 2 years of life. IMMUNOLOGIC PROPERTIES
- 12.
- 13. CMA affects 2-6% of infants. It results from an immunological reaction to one or more milk proteins. CMA may be immunoglobulin E (IgE) or non- IgE mediated, the involvement of two systems increases the probability of CMA. ESPAGHAN Guidelines for CMPA
- 14. Cow’s Milk Allergy(CMA): Key Concepts
- 15. Cow’s Milk USDA DairyProducts: Per capita consumption, United States. http://www.ers.usda.gov/data-products/dairy-data.aspx #.U+QWEPtRbTo ADVERSE REACTIONS can occur with milk consumption Food source for 9000 YEARS Current US consumption: 195 L/PERSON/YEAR
- 16. Classification of AdverseReactions to Food Adverse Reaction to Food Enzymatic Pharmacologic Other Nontoxic Toxic Non-Immune–Mediated Reaction1,2 (Food Intolerance) Due to lack of particular enzyme Due to components of the food Immediate food allergy Oral allergy Food protein enteropathies Eosinophilic gastroenteropathies IgE-mediated Non-IgE mediated (eg, T cell–mediated) Immune-Mediated Reaction1-3 (Food Allergy) Neurologic IgE=immunoglobulin E. 1. Burks AW, et al. Pediatrics. 2011;128(5):955-965. 2. Burks AW, et al. J Allergy Clin Immunol. 2012;129(4):906-920. 3. Spergel JM. Allergy Asthma Clin Immunol. 2006;2(2):78-85.
- 17. Impact of FoodAllergies Direct medical costs to the US health care system of $4.3 billion annually for childhood food allergies1 – Include clinician visits, emergency department visits, and hospitalization Costs borne by the family of $20.5 billion annually for childhood food allergies1 – Include lost labor productivity, out-of-pocket, and opportunity costs (caregiver needing to leave or change job) Quality of life decreased in UK, North American, European, and Asian studies2-5 Risk of compromised nutrition Long-term impact on feeding behaviors Risk of fatal reaction6 1. Gupta R, et al. JAMA Pediatr. 2013;167(11):1026-1031. 2. Avery NJ, et al. Pediatr Allergy Immunol. 2003;14(5):378-382. 3. Leung TF, et al. Clin Exp Allergy. 2009;539(6):890-896. 4. Flokstra-de Blok B, et al. Allergy. 2010;65(2):238-244. 5. Primeau MN, et al. Clin Exp Allergy. 2000;30(8):1135-1143. 6. Bock SA, et al. J Allergy Clin Immunol. 2001;107(1):191-193.
- 18. Family History andPhysical Examination During Early Diagnosis Key observations helpful upfront1: Learn about personal and family history of allergic disease Identify and create a list of suspected foods Document the precise description of reactions Key symptoms to watch for during a physical examination1,2: Cutaneous: Flushing, hives, angioedema, and eczema Gastrointestinal: Oropharyngeal pruritus and edema, abdominal cramping, nausea, vomiting, and diarrhea Pulmonary: Rhinorrhea, laryngeal edema, wheezing, coughing and shortness of breath Cardiovascular: Hypotension, tachycardia, and arrhythmias Behavioral: Irritability (preceding or in combination with other symptoms) 1. Sampson HA. J Allergy Clin Immunol. 1999;103(6):981-989. 2. Burks AW, et al. Pediatrics. 2011;128(5):955-965.
- 19. Important Gastrointestinal Manifestations AssociatedWith Non-IgE–mediated Food Allergy Eosinophilic esophagitis, Gastroenteritis1,2: – Postprandial vomiting, anorexia, abdominal distention, steatorrhea, failure to thrive, weight loss, food impaction, and gastric outlet obstruction – A subset with food-induced IgE-mediated reactions Dietary protein enteropathy2: – Diarrhea, failure to thrive, abdominal distention, and malabsorption – Less frequent anemia, edema, and hypoproteinemia Dietary protein enterocolitis2: – Vomiting and diarrhea Dietary protein proctocolitis2: – Gross blood in stool + other symptoms Celiac disease1: – Diarrhea, steatorrhea, malabsorption, abdominal distention, flatulence, + nausea and vomiting, failure to thrive, oral ulcers – Associated skin disease: dermatitis herpetiformis 1. Spergel JM. Allergy Asthma Clin Immunol. 2006;2(2):78-85. 2. Burks AW, et al. J Allergy Clin Immunol. 2012;129(4):906-920.
- 20. Description of AllergicReactions: Key items to note during an early diagnosis1,2: – Timing of onset in relation to food ingestion – Symptoms, their severity and duration of reaction – Treatment of reaction – Reproducibility of reaction after ingestion of suspected food – Most recent reaction 1. Sampson HA. J Allergy Clin Immunol . 1999;103(6):981-989. 2. Sampson HA et al. J Allergy Clin Immunol. 2014;134(5):1016-1025.e40.
- 21. Quick onset1-3 Anaphylaxis, etc1-3 Well-defined mechanism1 Easier to diagnose1 Validated tests1-3,a Delayed onset1-3 Eczema, reflux, etc2 Mechanism unclear2 Harder to diagnose2 No validated tests1,2 IgE-Mediated Versus Non-IgE– Mediated Reactions IgE Non-IgE aNot in infants. 1. Burks AW, et al. J Allergy Clin Immunol. 2012;129(4):906-920. 2. Burks AW, et al. Pediatrics. 2011;128(5):955-965. 3. Wang J, Sampson HA. J Clin Invest. 2011;121(3):827-835.
- 22. Features of IgE-MediatedAllergy1-3 1. Burks AW, et al. J Allergy Clin Immunol. 2012;129(4):906-920. 2. Burks AW, et al. Pediatrics. 2011;128(5):955-965. 3. Sicherer SH, et al. Pediatrics. 2012;129(1):193-197. Quick onset Reproducible Specific symptoms Specific foods Positive tests
- 23. Some Non-IgE–Mediated Reactions Eosinophilic gastroenteropathies Food protein–induced proctocolitis Food protein–induced enteropathy Food protein–induced enterocolitis Eczema Reflux,colic Constipation 1. Burks AW, et al. J Allergy Clin Immunol. 2012;129(4):906-920. 2. Burks AW, et al. Pediatrics. 2011;128(5):955-965.
- 26. Milk Allergy Lactose Intolerance CauseAn allergic reaction to the protein in milk and milk products A negative reaction to the sugar in milk and milk products. Symptoms •Persistent diarrhea •Vomiting •Skin Rashes •Extreme fussiness •Low or no weight gain •Gassiness •Wheezing •Bloating •Gassiness •Diarrhea Age of Onset •First few weeks or months of life (usually not after age 2) •Symptoms usually resolve at age 3 or 4. •Can develop at any age, but usually not in infants •Usually does not go away. Treatment •If the infant is breastfed: •Mothers should remove all milk proteins from their diet. •If the infant is bottle fed: Switch to a hypoallergenic amino acid-based formula . •Avoid products with lactose •Some amount of lactose may be tolerated by most persons.
- 27. What Factors MayHelp Explain an Increase in Food Allergy Prevalence? Changes in Diet1,2 – Vitamin D: An association between low Vitamin D levels and increased risk of FA has been suggested1 – Antioxidants: Some data with asthma but none yet with FA1 – Obesity: Obesity is associated with an inflammatory state; mostly studied in asthma1 – Dietary Fat: Despite the earlier results, recent meta-analysis found no clear evidence to support the use of Omega 3 and Omega 6 fatty acids for the primary prevention of atopic allergic disease development or sensitization2 Hygiene Hypothesis3 – Lack of exposure to infectious agents and gut flora increases susceptibility to allergic diseases; limited data for FA, except for mild effect of cesarean delivery FA=food allergy. 1. Sicherer SH et al. J Allergy Clin Immunol. 2014;133(2):291-307. 2. Anandan C et al. Allergy. 2009;64(6):840-848. 3. Kim H et al. Korean J Pediatr. 2013;56(9):369-376.
- 28.
- 29. Symptoms of Cow’sMilk Protein Allergy Can Mimic GERD in Infants • Recent American Academy of Pediatrics (AAP) guidelines for the management of gastroesophageal reflux recognize that cow’s milk protein allergy may have a clinical presentation that mimics GERD in infants AAP treatment algorithm (2013) for recurrent regurgitation and weight loss Lightdale JR, et al. Pediatrics. 2013;131(5):e1684-e1695. Algorithm used with permission of American Academy of Pediatrics. Education Close follow-up12 Improved?11 No Yes Consider: Hospitalization: Observe parent/child interaction Consider: NG or NJ tube feedings Consultation with Pediatric GI Consider: Acid suppression therapy and/or prokinetics 13 Education Close follow-up6 Evaluate further 4 Adequate calorie intake?5 Are there warning signs? 3 No Yes No Yes CBC, U/A, electrolytes, creatinine, urea, celiac screen (> 6 months) Consider: Upper GI series 7 History and physical examination2 Vomiting/regurgitation and poor weight gain 1 Manage accordingly 9 Abnormal?8 No Yes Dietary Management: Maternal exclusion diet in breastfed infants (Protein/hydrolysate formula in formula-fed infants) Thickened feedings Increased caloric density 10 • Accordingly, AAP recommends the following dietary modifications as a first-line approach to reflux management: – Exclusion of cow’s milk and eggs from the diet of mothers who breast-feed their infants – Protein hydrolysate formula in formula-fed infants – Thickened feeding
- 30.
- 31. The first stepis a thorough history and physical examination. In most cases with suspected CMA, the diagnosis needs to be confirmed or excluded by an allergen elimination and challenge procedure. ESPGHAN Guidelines , 2013
- 32. Children withgastrointestinal manifestations of CMA are more likely to have negative specific IgE test results compared with patients with skin manifestations. Specific IgG Antibodies or Determination of IgG antibodies or IgG subclass antibodies against CMP has no role in diagnosing CMPA & not recommended. ESPGHAN Guidelines ,
- 33. Food Allergy Management Currentmanagement of food allergy includes PHARMACOTHERAPY (in case of accidental exposure to the antigen) STRICT ALLERGEN AVOIDANCE (exclusion diet) Chapman JA, et al. Ann Allergy Asthma Immunol. 2006;96(suppl):S1-S68.
- 34. Milk for atopicbabies
- 35. The Long-term Effectof Nutritional Intervention With Hydrolysate Infant Formulas on Allergy in High-risk Children—The German Infant Nutrition Intervention (GINI) Study GINI was a study of 2,252 infants at high risk for atopy, enrolled at birth and followed through 10 years Infants randomized at birth to receive 1 of 4 formulas: an intact cow’s milk formula or 1 of 3 hydrolyzed formulas: pHF-W, eHF- W, eHF-C Strict intervention period as substitute for breast milk was 4 months to avoid modification of formula effect by solid foods Follow-up at 10 years with ISAAC questionnaire and invitation to study center for examination and blood sampling eHF-C=extensively hydrolyzed casein formula; eHF-W=extensively hydrolyzed whey formula; ISAAC=International Study of Asthma and Allergies in Childhood; pHF-W=partially hydrolyzed whey formula. von Berg A et al. J Allergy Clin Immunol. 2013;131(6):1565-1573.
- 36. The GINI Study—10Year Analysis 2 key takeaway points from the GINI study: – Feeding with the pHF-W and eHF- C formulas in the first 4 months has a positive effect on cumulative incidence of atopic eczema/dermatitis in high-risk children, lasting until 10 years – However, feeding cow’s milk protein hydrolysate formulas compared with cow’s milk formula has neither a positive effect on asthma and allergic rhinitis nor such an effect on allergic sensitization Physiciandiagnosedeczema[adj.%] Adjusted cumulative incidence of parent-reported physician-diagnosed eczema 45 40 35 30 25 20 15 10 9 8 7 6 0 1 2 3 4 5 6 7 8 9 10 Age [years] pHF-W eHF-C eHF-W CMF CMF=standard cow’s milk formula; eHF-C=extensively hydrolyzed casein formula; eHF-W=extensively hydrolyzed whey formula; pHF-W=partially hydrolyzed whey formula. Reprinted from J Allergy Clin Immunol. 2013;131(6):1565-1573. Von Berg A et al. Allergies in high-risk schoolchildren after early intervention with cow’s milk protein hydrolysates: 10-year results from the German Infant Nutritional Intervention (GINI) study. ©2013, with permission from Elsevier. Overall Study Conclusion: These results support the use of cow’s milk protein hydrolysate infant formula in high-risk infants to reduce the risk for atopic eczema but not for respiratory allergies
- 37. Babies at highrisk for developing allergy First degree relatives with either : Food allergy Asthma OR moderate to severe atopic dermatitis (AD).
- 38. Human milkis the optimal source of nutrition for term infants during the first 6 months of life. There is no evidence to support administration of a hydrolyzed formula, in preference to exclusive breastfeeding, to prevent allergy. AAP Website , 2015
- 39. To preventallergic diseases in high risk infants, who cannot be exclusively breastfed, a partially or extensively hydrolyzed formula, in preference to a conventional cow's milk or soy protein formula can be offered. AAP Website , 2015
- 40. Evaluation of anAmino Acid−Based Formula in Infants Not Responding to Extensively Hydrolyzed Protein Formula J Pediatr Gastroenterol Nutr. 2016 Nov; 63(5): 531– 533.
- 41. Recommended managementof CMPA includes the initiation of a hydrolyzed protein formula. Although 90% of infants exhibit healthy growth and reduced allergic symptoms on an EH formula, highly sensitive infants may require an AAF. Incidence and severity of AD and vomiting/spitting up were significantly reduced during the 12-week study period , indicating that the AAF properly managed CMPA symptoms.
- 42. In aprospective, controlled study, atopic infants with CMPA receiving an AAF for 6 months demonstrated clinical improvement and proper growth compared with infants fed an EHP formula . In another study, data suggested that hypoallergenic (AAFs) improved the gut barrier function and minimized gastrointestinal complications in atopic infants. The results in the study indicated that longer-term feeding of an AAF in infants with poorly managed CMPA, improved long-term allergy management.
- 43.
- 44. Allergy marchis a worldwide problem! Be proactive in preventing allergic diseases in infants and children rather than treating a current condition. Breast milk is the gold standard for feeding babies , either atopic or non atopic.
- 45. There isno evidence to support administration of a hydrolyzed formula, in preference to exclusive breastfeeding, to prevent allergy. To prevent allergic diseases in high risk infants, who cannot be exclusively breastfed, a partially or extensively hydrolyzed formula, in preference to a conventional cow's milk or soy protein formula.
- 46. If theinfant has milk protein allergy & breastfed, mothers should remove all milk proteins from their diet. If the infant is bottle fed, switch to a hypoallergenic formula, either partially or extensively hydrolyzed formula. However , some babies may need an amino acid based formulas to improve allergic manifestations & growth.