The diagnostic value of skin prick testing in children with food allergy

The diagnostic accuracy of the skin prick test (SPT) in food allergy is controversial. We have developed diagnostic cut-off levels for SPT in children with allergy to cow milk, egg and peanut. Based on 555 open food challenges in 467 children (median age 3.0 yr) we defined food-specific SPT weal diameters that were '100% diagnostic' for allergy to cow milk (>or=8 mm), egg (>or=7 mm) and peanut (>or=8 mm). In children < 2 yr of age, the corresponding weal diameters were >or=6 mm, >or=5 mm and >or=4 mm, respectively. These SPT cut-off levels were prospectively validated in 90 consecutive children 相似文献   

The diagnosis of IgE-mediated food allergy in childhood

IgE-mediated food allergy is a common condition in childhood and a recognized public health concern. An accurate diagnosis of food allergy facilitates the avoidance of the allergen – and cross-reactive allergens – and allows for safe dietary expansion. The diagnosis of food allergy relies on a combination of rigorous history, physical examination, allergy tests [skin prick tests (SPT) and/or serum-specific IgE] and oral food challenges. Diagnostic cut-off values for SPT and specific IgE results have improved the diagnosis of food allergy and thereby reduced the need to perform oral food challenges. This clinical case series seeks to highlight a contemporary approach to the diagnosis of food allergy in children strategies.     

Shellfish allergy in children

Food allergies affect approximately 3.5–4.0% of the world's population and can range from a mere inconvenience to a life-threatening condition. Over 90% of food allergies in childhood are caused by eight foods: cow's milk, hen's egg, soy, peanuts, tree nuts, wheat, fish, and shellfish. Shellfish allergy is known to be common and persistent in adults, and is an important cause of food induced anaphylaxis around the world for both children and adults. Most shellfish-allergic children have sensitivity to dust mite and cockroach allergens. Diagnostic cut-off levels for skin prick testing in children with shrimp allergy exist but there are no diagnostic serum-specific immunoglobulin E (IgE) values. All patients with symptoms of IgE-mediated reactions to shellfish should receive epinephrine autoinjectors, even if the initial symptoms are mild. In this study, we review three cases of clinical presentations of shellfish allergy in children.     

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??Abstract??Objective To investigate the diagnostic value of mean diameter of SPT in food allergic infants. Methods Totally 91 infants suspected with food allergy ??median age 7.35±2.94 months?? were selected??and all patients received family history inquiry??skin prick test and open food challenge.The mean diameter of SPT was measured??and OFC was performed to confirm food allergy.Diagnostic value of skin prick test, including the sensitivity and specificity, was calculated.In addition??receiver operating characteristic curve??ROC?? was plotted and area under the curve??AUC??was calculated to quantify the accuracy of the parameter.The SPSS software package version 13.0 for windows was used for all statistical analysis. Results A total of 128 babies received food challenge test?? in which there were 109 times of OFC positive and 19 times negative??totally 79 infants were diagnosed with FA.The induced symptoms of food challenge test included skin symptoms??70.6%??, gastrointestinal symptoms??20.2%??, rest with crying?? coughing?? rubbing eyes??etc.??9.2%??.When the rash MD was ≥3 mm??the sensitivity of SPT diagnosis milk??egg white and protein allergy was 19%??60.6% and 60.5% respectively??the area under ROC curve of rash MD in the milk??egg white??protein was 0.718??0.604 and 0.716 respectively?? the rates of three food SPT test results complying with the OFC were 44.4%??53.7% and 65.9%??the rates being 62.5%?? 58.3% and 31.3% in positive family history??when family history was negative??the area under the ROC curve of rash MD was 0.793. In the cases with positive family history??the area of ROC curve was 0.533.When rash MD of milk??egg white and protein was ≥2.2??5.0??4.7 mm or the rash MD was ≥3.25mm in children with a negative family history??SPT FA diagnostic specificity could be up to 100%. Conclusion SPT has some value in the diagnosis of FA. By finding the critical value of SPT FA and comprehensive analysis of family history??doctors can improve the diagnostic rate of FA. SPT can prevent some suspicious FA infants from food challenge test. It is very important to obtain rapid clinical diagnosis and to reduce the risk and burden to their families.     

Correlation between skin prick test using commercial extract of cow''s milk protein and fresh milk and food challenges

The skin prick test (SPT) is regarded as an important diagnostic measure in the diagnostic work-up of cow's milk protein allergy. It is not known whether commercial extracts have any advantage over fresh milk. The aims of the study were to (i) compare the diagnostic capacity of SPTs for the three main cow's milk proteins (alpha-lactalbumin, casein and beta-lactoglobulin) with fresh milk and (ii) determine a cut-off that discriminates between allergic and tolerant children in a controlled food challenge. A study was carried out on 104 children consecutively attending two paediatric allergy clinics for suspected cow's milk allergy. A clinical history, SPTs with fresh cow's milk and commercial extracts of its three main proteins and a challenge test were performed on all the children. A study of the validity of the prick test was also performed by taking different cut-off points for fresh milk and its proteins. Twenty-eight of 104 challenge tests (26.9%) were positive. At a cut-off point of 3 mm, fresh milk showed the greatest negative predictive value (98%), whereas casein showed the greatest positive predictive value (PPV, 85%). Calculation of 95% predicted probabilities using logistic regression revealed predictive decision points of 12 mm for lactalbumin, 9 mm for casein, 10 mm for beta-lactoglobulin and 15 mm for fresh cow's milk. We found that the greater the number of positive SPTs for milk proteins, the more likely the positive response to challenge. Having a positive SPT for all three milk proteins had PPV of 92.3% and would seem more clinically useful than any cut-off. Both fresh milk and cow's milk extract of the three main proteins could be useful in the diagnostic work-up of cow's milk allergy. Finding positivity to all three cow's milk proteins seems to be a simpler and more useful way of avoiding oral food challenges.     

Cow's milk allergic children can present sensitisation to probiotics

Aim: To evaluate sensitivity to different probiotics in children with cow's milk allergy.
Methods: Eighty-five patients (age range: 4 months –12 years) presenting atopic dermatitis (AD) were enrolled. Skin prick test (SPT) responses to three different probiotics preparations (Fiorilac®, Dicoflor® and Reuterin®) were evaluated in addition to relevant food allergens.
Results: Thirty-nine patients out of 85 (45.8%) had a positive skin response to prick test for cow's milk (3 with reaction <3 mm). Of the thirty-six patients with a cow's milk weal reaction >3 mm, twenty-eight (77.8%) had a skin response to Fiorilac®, four patients (11%) to Dicoflor® and four (11%) to Reuterin®. The proportion of SPT reaction to all the investigated probiotics preparations was significantly lower than cow's milk (r = 9.406; p = 0.002). A significantly higher sensitization was observed for Fiorilac® versus Dicoflor® (r = 30.916; p < 0.001) and versus Reuterin® (r = 34.133; p < 0.001).
Conclusion: Probiotic use in patients with cow's milk allergy has to be limited to products that do not contain milk. This should be clearly reported in the label. In selected patients, it is advisable to perform a screening SPT with the product to evaluate its potential contamination with milk.     

婴幼儿鸡蛋与牛奶过敏食物皮肤点刺试验的诊断价值

目的 通过对皮肤点刺试验疹团平均直径与开放性食物激发试验的相关性研究,获得有确诊食物过敏价值的皮肤点刺试验界值点,为简化临床诊断程序提供依据.方法 采用前瞻性研究,选择重庆医科大学附属儿童医院儿保科可疑食物过敏儿童173名,均进行皮肤点刺试验及开放性食物激发试验.测量并记录皮肤点刺试验疹团平均直径,通过开放性食物激发试验确诊食物过敏患儿.采用SPSS 13.0软件包进行统计学处理.将开放性食物激发试验作为诊断的金标准,通过四格表计算疹团平均直径的敏感度、特异度、阳性预测值及阴性预测值.通过受试者工作特征曲线及曲线下面积对疹团平均直径诊断价值进行评价;同时获取具有100%诊断价值的平均直径界值点.结果 173名婴幼儿年龄范围1～24个月,平均(9.39±5.67)个月共进行271次食物激发试验(其中阳性结果123次),99例婴幼儿被确诊为食物过敏.食物激发试验诱发症状主要表现为皮肤症状(87.0%),其次是胃肠道症状(9.8%).蛋白、蛋黄、牛奶皮肤点刺试验的受试者工作特征曲线的曲线下面积分别为0.794、0.804及0.904.当皮肤点刺试验疹团平均直径≥3 mm时,敏感度在71%～87%之间,特异度在31%～57%之间.当蛋白、蛋黄、牛奶皮肤点剌试验疹团平均直径分别≥8.5、5.5、5.5 mm时,皮肤点刺试验对食物过敏的诊断准确率可达100%.结论 皮肤点刺试验疹团平均直径对食物过敏的临床诊断准确性较好,通过其100%诊断界值点,可避免部分可疑食物过敏患儿进行食物激发试验.

Abstract：

Objective Mean diameter is the most common used parameter for wheal response assessment after skin prick test.This study aimed to investigate the diagnostic capacity of mean diameter according to the outcome of oral food challenge, and to determine the cut-off points that could render food challenges unnecessary.Method Data of 173 children referred to the Division of Primary Child Health Care for the evaluation of suspected food allergy were prospectively studied.All children underwent skin prick test and open food challenge to the relevant food(s) in clinic.The mean wheal diameter of skin prick test was measured, and open food challenge was performed to confirm food allergy. The SPSS software package version 13.0 for windows ( SPSS, Chicago, IL,USA) was used for all statistical analysis.Open food challenge was taken as the gold standard for diagnosis.Diagnostic capacity of skin prick test, including the sensitivity, specificity, positive predictive value, negative predictive value, was calculated by cross-table.In addition, receiver operating characteristic curve ( ROC ) was plotted and area under the curve ( AUC ) was calculated to quantify the accuracy of the parameter.Result For the 173 children,271 open food challenges were performed with egg white, egg yolk and cow's milk, In which 123 were positive, 99 children were diagnosed as food allergy.Cutanuous symptoms ( 87.0% ) were most common, followed by gastrointestinal symptoms (9.8% ).The AUC of mean diameter was 0.794 for egg white, 0.804 for egg yolk and 0.904 for cow's milk.The sensitivity of skin prick test with a cut-off value of ≥3 mm was ranged from 71% to 87%,while the specificity was between 31% and 57%.The authors also defined food specific skin prick test mean diameters that were 100% diagnostic for allergy to egg white ( ≥8.5 mm), egg yolk ( ≥5.5 mm), cow's milk ( ≥5.5 mm).Conclusion Predictive decision points for a positive outcome of food challenges can be calculated for egg and cow's milk using mean diameter.It may help to simplify the diagnostic procedure of food allergy.     

The pendulum between food protein-induced enterocolitis syndrome and IgE-mediated milk allergy

The transition from milk protein-induced enterocolitis syndrome to IgE-mediated milk allergy is uncommon. Herein, we describe three infants that suffered from recurrent vomiting and restlessness in response to cow's milk formula with negative skin prick to milk and therefore diagnosed as milk protein-induced enterocolitis syndrome. After recovering and reintroducing cow's milk formula, they developed disseminated urticaria and positive skin prick test to cow milk compatible with IgE-mediated milk allergy. CONCLUSION: An infant that recovers from cow milk food-induced enterocolitis syndrome might develop afterward IgE-mediated cow milk allergy.     

The pattern of sesame sensitivity among infants and children

Recently, we found sesame to be a major cause of severe IgE-mediated food allergic reactions among infants and young children in Israel. The purpose of this study was to describe the different patterns of sesame sensitivity. We have identified three subgroups among our patients (n = 32). Group I (n = 23, M/F; 14/9) consisted of cases with IgE-mediated sesame allergy. The mean age of the first allergic reaction was 11.7 months. Although the main clinical manifestation was urticaria/angiedema (n = 14, 60%), anaphylaxis was the presenting symptom in seven (30%) patients; all of them were younger than 1 year. Sixteen (70%) were found to be allergic to other foods, and other atopic diseases were identified in 18 (78%) patients. Three patients 'outgrew' their allergy within 1–2 years. Group II (n = 2) included cases in whom sesame allergy was ruled out based on a negative skin prick test (SPT) together with a negative open oral challenge. Group III (n = 7) consisted of patients that were found to be SPT positive for sesame as part of a screening for other food allergies. Although sesame products have become fashionable in westernized countries, early exposure may cause sesame to share eventually the same 'noteriety and fate' as peanut – a major cause of severe food allergic reactions.     

Egg allergy in infancy predicts respiratory allergic disease by 4 years of age

Sensitization to hen's egg early in life has been proposed as a predictor for respiratory allergic disease during childhood. However, symptomatic egg allergy in infancy has not been studied in this context. In 1989, a cohort of consecutive births was recruited. Data on family history of atopy and environmental factors were collected. At 4 years of age, 1218 children were seen of whom 981 were skin‐prick tested with a range of food and aero‐allergens. Of the 1218 children, 29 (2.4%) had suffered symptomatic egg allergy (20 during infancy). Egg allergy in infancy was associated with increased respiratory (asthma, rhinitis) allergic disease (odds ratio [OR] 5.0, 95% confidence intervals [CI] 1.1–22.3; p < 0.05) at 4 years of age, with a positive predictive value (PPV) of 55.0%. The addition of infantile eczema to egg allergy increased the PPV to 80% whereas the addition of family history of atopy had no effect. Egg allergy also increased aero‐allergen sensitization (OR 6.1, CI 1.1–37.5; PPV 61.1%; p < 0.05). As a predictor for respiratory allergic disease and aero‐allergen sensitization, it carried a high specificity but poor sensitivity. Hence, egg allergy in infancy, especially when coexisting with eczema, increases respiratory allergic symptoms and aero‐allergen sensitization in early childhood.     

Serum specific-IgE antibodies to peptides detected in a casein hydrolysate formula

Up to 2. 59% of infants are affected by cow milk hypersensitivity in the first two years of life, although most of these children will "outgrow" their reactivity within 2-3 years. Extensively hydrolyzed ("hypoallergenic") cow milk-based formulae are often recommended as a substitute formula and are generally well tolerated. However, a small minority of cow milk-allergic children experience allergic reactions to the hypoallergenic formulae as well. Utilizing inhibition-ELISAs and sera from patients with IgE-mediated cow milk allergy, we have identified residual protein fractions less than 20 kD in several of the extensively hydrolyzed cow milk-based formulae. Although many of the cow milk allergic children had positive skin prick lests [SPT] to one of the hydrolysate formulae (Nutramigen^ma), the positive skin test result generally did not correlate with clinical reactivity, although the negative predictive value of the negative SPT was excellent. Children with IgE-mediated cow milk allergy and a positive skin prick test to the hypoallergenic formula should probably receive their first dose of the formula in a medical setting so that appropriate therapy can be administered in the unlikely event of an allergic reaction.     

The clinical significance of food specific IgE/IgG4 in food specific atopic dermatitis

Food is closely associated with the pathogenesis of atopic dermatitis. Food allergy is usually mediated by IgE antibody to specific food proteins and determination of specific IgE antibody is the basis of the common diagnostic test for food allergy. IgG4 have been reported as blocking antibody and the protective effects of blocking antibody may be clear in inhalant allergy. However, the role of IgG4 in food allergy is still a matter of debate. In this study, the clinical significance of food allergen-specific IgE/IgG4 in atopic dermatitis was investigated and compared with that of IgE. A total of 97 patients who fulfilled the diagnostic criteria for atopic dermatitis participated in this study. Skin prick test and allergy patch test were performed. Specific IgE and IgG4 concentration were measured using allergy protein chip, 'AllergyChip'. Double blinded placebo controlled food challenge test (DBPCFC) was performed for the diagnosis of allergy to milk, egg white, wheat, and soybean. DBPCFCs for milk, egg white, soybean, and wheat were performed. The positive rates were 31.7% (19/60) in milk, 36.7% (18/49) in egg white, 30.4% (7/23) in soybean, and 34.8% (8/23) in wheat. Mean IgE/IgG4 levels in DBPCFC (+) subjects is higher than those in DBPCFC (-) subjects in all food items studied. Of them, there were significantly different between two groups in egg white and wheat (Egg white in DBPCFC (+) vs. (-): 0.4 +/- 0.3 vs. 0.2 +/- 0.2, wheat in DBPCFC (+) vs. (-): 1.2 +/- 1.2 vs. 0.3 +/- 0.3, p < 0.05). Allergen-specific IgE/IgG4 may provide one of the clues to understand the mechanism of food allergy in atopic dermatitis. The present study suggests that protein microarray can be one of the useful methods to assess ongoing status of allergic diseases.     

Sensitization to turnip rape and oilseed rape in children with atopic dermatitis: a case-control study

Turnip rape and oilseed rape 2S albumins are new allergens in children with atopic dermatitis suspected for food allergy. We recently found that 11% (206/1887) of these children had a positive skin prick test to seeds of oilseed rape ( Brassica napus ) and/or turnip rape ( Brassica rapa ). In the present case-control study we examined how the children with atopic dermatitis sensitized to turnip rape and oilseed rape had been breast-fed and whether they had some common sensitization pattern to certain foods or pollens. A total of 64 children with atopic dermatitis and a positive skin prick test to turnip rape and/or oilseed rape (≥5 mm) were examined. Sixty-four age- and sex-matched children with atopic dermatitis but negative skin prick tests to turnip rape and oilseed rape served as case controls. The turnip rape and/or oilseed rape sensitized children with atopic dermatitis had significantly more often positive skin prick tests reactions and IgE antibodies to various foods (cow's milk, egg, wheat, mustard; p < 0.01) and pollens (birch, timothy, mugwort; p < 0.01) than the control children. They had been exclusively breast-fed for a longer period (median 4 months; p < 0.05) and had more often associated asthma (36%) and allergic rhinitis (44%). Children with atopic dermatitis sensitized to oilseed rape and turnip rape had high frequency of associated sensitizations to all foods and pollens tested showing that oilseed plant sensitization affects especially atopic children who have been sensitized to multiple allergens.     

Frequent IgE sensitization to latex, cow's milk, and egg in children with short bowel syndrome

Children with short bowel syndrome (SBS) undergo frequent operations, so they are at risk for sensitizing to latex. There have been isolated reports of sensitization to food in these children. In a cross-sectional study, we assessed sensitization to latex, cow's milk, and egg with skin prick tests (SPT) and serum-specific immunoglobulin E (IgE) in 14 children with SBS. Data were collected about the number of operations with latex devices, serum total IgE, and history of feeding with milk formula. Ten children were sensitized to latex (specific IgE median: 6.7 kU/l, range: 0.5–33). Compared with those non-sensitized, sensitized children had significantly (p < 0.05) higher levels of serum total IgE in z-units (mean rank 3.25 vs. 9.2, respectively), and more operations with latex devices (mean rank 3.75 vs. 9). Eight children were sensitized to cow's milk, one with only positive SPT, the other seven with serum-specific IgE (median: 3.5, range: 0.5–21.1 kU/l), and five to egg (specific IgE median: 0.68, range: 0.58–2.17 kU/l). Except for some isolated days with cow's milk formula, the children had been initially fed with a diet without intact cow's milk proteins. Sensitization to latex, cow's milk, and egg is very frequent in children with SBS. They should be treated in a latex-free environment since the very early stages of the disease, and should be routinely studied regarding food sensitization, as this might contribute as an added factor in the chronic diarrhea of these patients.     

Frequency of food allergy in a pediatric population from Spain

We evaluated the prevalence and characteristics of the principal foods implicated in 355 children diagnosed with IgE-mediated food allergy. Diagnosis was established on the basis of positive clinical history for the offending food, positive specific IgE by skin prick test and RAST, and open food challenge. Our results showed the principal foods involved in allergic reactions are: eggs, fish, and cow's milk. These are followed in frequency by fruits (peaches, hazelnuts and walnuts), legumes (lentils, peanuts and chick peas) and other vegetables (mainly sunflower seeds). The legumes demonstrated the highest degree of clinical cross-reactivity. Most patients with food allergy reacted to one or two foods (86.7%). Only 13.3% of patients reacted to 3 or more foods, mostly to legumes and fruits. We found that food allergy begins most frequently in the first (48.8%) and second (20.4%) years of life. Allergy to proteins of cow's milk, egg, and fish begins predominantly before the second year, demonstrating a clear relationship with the introduction of these foods into the child's diet. Allergy to foods of vegetable origin (fruits, legumes and other vegetables) begins predominantly after the second year.;     

Egg allergy

Egg is one of the most important allergen in childhood feeding. The pathogenic mechanism in egg allergy is immediate, type I, IgE-mediated hypersensitivity, although other mechanisms are possible. The aim of this review is to point out that diagnosis of egg protein allergy is mainly clinical and double-blind placebo-controlled food challenge is nowadays the gold standard. Although reference values for prick test and sIgE have been proposed, which can foretell symptoms in groups of egg sensitive children, these values are not so accurate for a single diagnosis, since they mainly refer to children with atopic dermatitis, and to specific ranges of age. Children with atopic dermatitis can show allergy at the first egg ingestion, as for cow milk allergy, because the sensitization may happen in utero or through breast milk. The only available therapy in case of egg allergy is the complete removal of hen egg from the child's diet, yet considering cross-reaction with other birds' eggs, while cross- reaction with poultry and/or other birds' meat has been signalled only in 5% of cases. From this review it is clear how egg allergic children can be vaccinated against measles-mumps rubella.     

An evaluation of the diagnostic value of different skin tests with egg in clinically egg-allergic children having atopic dermatitis

Skin testing is a common diagnostic procedure in food allergy, but the final diagnosis of food allergy is based on the clinical response to food challenge. We studied the value of the skin prick-prick test (SPT), skin application food test (SAFT) and atopy patch test (APT) with fresh egg extract in diagnosing egg allergy. Ten clinically egg-allergic children with atopic dermatitis (AD; age 10 months to 8.4 yr, mean 3.4 yr) and 10 egg-tolerant children with and 10 without AD (age 2.4-11 yr, mean 5.5 yr) participated. In SAFT several false-negative reactions were seen, whereas all clinically egg-allergic children were positive in SPT and 40-60% in APT. In APT and in SPT false-positive reactions to egg were observed. In this study comprising a small number of patients including control subjects, neither SAFT nor APT with fresh whole egg extract were able to increase the diagnostic accuracy in detecting egg-allergic children with AD compared with SPT.     

Characterizing the relationship between sesame,coconut, and nut allergy in children

Stutius LM, Sheehan WJ, Rangsithienchai P, Bharmanee A, Scott JE, Young MC, Dioun AF, Schneider LC, Phipatanakul W. Characterizing the relationship between sesame, coconut, and nut allergy in children.
Pediatr Allergy Immunol 2010: 21: 1114–1118.
© 2010 John Wiley & Sons A/S Sesame and coconut are emerging food allergens in the United States. We sought to examine whether children allergic to peanuts and tree nuts are at increased risk of having an allergy to sesame or coconut. We performed a retrospective chart review of children who underwent skin prick testing (SPT) to sesame and coconut and identified 191 children who underwent SPT to sesame and 40 to coconut. Sensitization to sesame was more likely in children with positive SPT to peanuts (odds ratio [OR] = 6.7, 95% confidence interval [CI] [2.7–16.8], p < 0.001) and tree nuts (OR = 10.5, 95% CI [4.0–27.7], p < 0.001). Children with histories of both peanut and tree nut reaction were more likely to have a history of sesame reaction (OR = 10.2, 95% CI [2.7–38.7], p < 0.001). Children with sensitization or allergy to peanuts or tree nuts were not more likely to be sensitized or allergic to coconut. In conclusion, children with peanut or tree nut sensitization were more likely to be sensitized to sesame but not coconut. Children with clinical histories of both peanut and tree nut allergy were more likely to be allergic to sesame.     

General paediatricians and the case of resolving peanut allergy

Children with peanut allergy are almost always advised to avoid nuts for life. There have been recent reports from academic centres that in some cases the allergy might resolve and thus these dietary restrictions can be lifted. To evaluate resolution of peanut allergy in a selected group of children in a general paediatric setting. Children 4-16 yr old with a clear history of an allergic reaction to peanuts who had not had any reaction in the previous 2 yr were eligible. Specific immunoglobulin E (IgE) or skin prick test (SPT) at the time of diagnosis was sought. A SPT and specific IgE was then done and if this was 相似文献   

Safety of a new, ultrafiltrated whey hydrolysate formula in children with cow milk allergy: a clinical investigation

The purpose of this study was to determine whether a new ultrafiltrated whey hydrolysate infant formula, Profylac®, could be administered safely to children with cow milk protein allergy/intolerance. Profylac has a stated molecular weight of < 8 kD and at least 30, 000 times reduced antigenicity which is controlled by a combination of ELISA-techniques and immunochemical methods. The study comprised 66 children with cow milk protein allergy/intolerance diagnosed by controlled elimination/ challenge procedures. The children were aged 1 month-14. 5 years, median 1% years and 15 were below 1 year. Thirty-five of these children had proven IgE-mediated reactions (cow milk protein allergy). Sixty-one of the children had at least two different symptoms and 31 had concomitant allergies to other foods and/or inhalants. All 66 children underwent and tolerated open, controlled challenges with Profylac. A total of 64 children continued having Profylac daily for at least 3 months and 58 for at least 6 months after challenge. Nine of the children older than 1 year did not like the taste and only had Profylac in minor amounts. No side effects were registered. Fifteen of the infants were below 1 year of age, and this group was compared with an age matched group of 16 infants challenged with and fed an extensively hydrolysed casein hydrolysate, Nutramigen®. All the infants in these two groups accepted and tolerated Profylac and Nutramigen, respectively, and no side effects were registered. Among the 35 patients with IgE-mediated reactions 6% (2/35) had positive skin prick tests and 11% (3/28) had specific IgE class 2 against Profylac, 2 of the latter before intake of Profylac. None of the patients with non-IgE-mediated reactions had a positive skin prick test or specific IgE against Profylac. The study provides 95% confidence that this product is tolerated by at least 95% of children with cow milk protein allergy/intolerance and by 90% with IgE-mediated reactions. We conclude, that this ultrafiltrated whey hydrolysate is generally safe to feed to children with verified adverse reactions to cow milk protein, including children with IgE-mediated reactions. The taste of the product was widely accepted, also by older children.