Silk garments plus standard care compared with standard care for treating eczema in children: A randomised, controlled, observer-blind, pragmatic trial (CLOTHES Trial).

BACKGROUND: The role of clothing in the management of eczema (also called atopic dermatitis or atopic eczema) is poorly understood. This trial evaluated the effectiveness and cost-effectiveness of silk garments (in addition to standard care) for the management of eczema in children with moderate to severe disease. METHODS AND FINDINGS: This was a parallel-group, randomised, controlled, observer-blind trial. Children aged 1 to 15 y with moderate to severe eczema were recruited from secondary care and the community at five UK medical centres. Participants were allocated using online randomisation (1:1) to standard care or to standard care plus silk garments, stratified by age and recruiting centre. Silk garments were worn for 6 mo. Primary outcome (eczema severity) was assessed at baseline, 2, 4, and 6 mo, by nurses blinded to treatment allocation, using the Eczema Area and Severity Index (EASI), which was log-transformed for analysis (intention-to-treat analysis). A safety outcome was number of skin infections. Three hundred children were randomised (26 November 2013 to 5 May 2015): 42% girls, 79% white, mean age 5 y. Primary analysis included 282/300 (94%) children (n = 141 in each group). The garments were worn more often at night than in the day (median of 81% of nights [25th to 75th centile 57% to 96%] and 34% of days [25th to 75th centile 10% to 76%]). Geometric mean EASI scores at baseline, 2, 4, and 6 mo were, respectively, 9.2, 6.4, 5.8, and 5.4 for silk clothing and 8.4, 6.6, 6.0, and 5.4 for standard care. There was no evidence of any difference between the groups in EASI score averaged over all follow-up visits adjusted for baseline EASI score, age, and centre: adjusted ratio of geometric means 0.95, 95% CI 0.85 to 1.07, (p = 0.43). This confidence interval is equivalent to a difference of -1.5 to 0.5 in the original EASI units, which is not clinically important. Skin infections occurred in 36/142 (25%) and 39/141 (28%) of children in the silk clothing and standard care groups, respectively. Even if the small observed treatment effect was genuine, the incremental cost per quality-adjusted life year was £56,811 in the base case analysis from a National Health Service perspective, suggesting that silk garments are unlikely to be cost-effective using currently accepted thresholds. The main limitation of the study is that use of an objective primary outcome, whilst minimising detection bias, may have underestimated treatment effects. CONCLUSIONS: Silk clothing is unlikely to provide additional benefit over standard care in children with moderate to severe eczema. TRIAL REGISTRATION: Current Controlled Trials ISRCTN77261365.

Prevalence and cumulative incidence of food hyper-sensitivity in the first 10 years of life.

BACKGROUND: Prevalence, incidence and natural history of food hypersensitivity (FHS) and its trends in an unselected cohort of older children are unclear. METHODS: A birth cohort born on the Isle of Wight (UK) between 2001 and 2002 was followed up prospectively. Children were clinically examined and skin prick tested at set times and invited for food challenges when indicated. At 10 years of age, children were also invited for a blood test. RESULTS: A total of 969 children were recruited at 12 weeks of pregnancy, and 92.9%, 88.5%, 91.6% and 85.3% were assessed at 1, 2, 3 and 10 years. Prevalence of sensitization to any allergen over 10 years was 186 of 969 (19.2%; 95% CI: 16.84-21.8) and 108 of 969 (11.2%; 95% CI: 9.31-13.29) children were sensitized to at least one predefined food allergen. Excluding wheat (due to cross-reactivity with pollen), 40 of 969 (4.1%; 95% CI: 3.19-5.32) children were sensitized to a predefined food allergen. Using food challenges and/or a good clinical history, the cumulative incidence of food hypersensitivity (FHS) in the first decade of life was 64 of 947 (6.8%, 95% CI: 5.2-8.4), while the prevalence of FHS at 10 years was 30 of 827 (3.6%, 95% CI: 2.54-5.15). The vast majority, 25 of 827 (3.0%, 95% CI: 1.8-4.2), suffered from IgE-mediated food allergy, while 5 of 827 (0.6%, 95% CI: 0.07-1.3) had non-IgE-mediated food allergy/food intolerance. CONCLUSIONS: By the age of 10 years, 6.8% of children suffered from FHS based on food challenges and a good clinical history. There was a large discrepancy between reported and diagnosed FHS.

The prevalence, natural history and time trends of peanut allergy over the first 10 years of life in two cohorts born in the same geographical location 12 years apart.

BACKGROUND: The aim of this study was to explore the natural history of peanut allergy in childhood in two birth cohorts from the same geographical region in the South of England. METHODS: The FAIR birth cohort was established on the Isle of Wight (UK) between 2001 and 2002 (n = 969). Children were followed up prospectively, skin prick tested (SPT) to peanut allergens at 1, 2, 3 and 10 years and food challenges performed. The Isle of Wight (IOW) birth cohort was established in 1989 (n = 1456). SPTs were performed at 1, 2, 4 and 10 years. Peanut allergy was based on positive SPT and a good clinical history. RESULTS: In the FAIR cohort, the prevalence of sensitization to peanut was 0.4%, 2.0%, 2.0% and 2.4% at 1, 2, 3 and 10 years, respectively. At 10 years of age, 12 of 828 (1.5%) children were diagnosed with peanut allergy. One child (8%) outgrew her peanut allergy between 3 and 10 years and two children (15%) presented with new onset peanut allergy. Over the first 10 years of life, 13 of 934 (1.4%) children were diagnosed with peanut allergy. In the IOW cohort, 6 of 1034 (0.58%) were diagnosed with peanut allergy at 10 years. We found no significant differences between the FAIR and the IOW birth cohort for any of the time points studied. CONCLUSION: Peanut allergy appears to be stable over the first 10 years of life in our cohorts. There was no significant difference in peanut sensitization or clinical peanut allergy between 1989 and 2001.

Cows' milk exclusion diet during infancy: Is there a long-term effect on children's eating behaviour and food preferences?

BACKGROUND: Dietary restriction during infancy may influence later eating behaviour. The aim of this study was to determine whether consuming a cows' milk exclusion (CME) diet during infancy affects eating habits in later childhood, once cows' milk has been reintroduced into the diet. METHODS: Children were recruited from two large birth cohort studies in the UK. A small number of participants were recruited from allergy clinic. Two groups were recruited: an experimental group of children who had consumed a CME diet during infancy and a control group, who had consumed an unrestricted diet during infancy. Parents and children completed questionnaires regarding eating behaviour and food preferences. RESULTS: In total, 101 children of mean age 11.5 years were recruited (28 CME and 73 controls). The CME group scored significantly higher on 'slowness of eating' and on the combined 'avoidant eating behaviour' construct (p < 0.01). The number of foods avoided and symptoms was associated with higher levels of avoidant eating behaviour (p < 0.05). The CME group rated liking for several dairy foods (butter, cream, chocolate, full fat milk and ice cream) significantly lower than the control group (p < 0.05), although there were no significant differences seen for any other category of food. CONCLUSION: This study demonstrated that consuming a CME diet during infancy has persistent and long-term effects on eating habits and food preferences. To reduce future negative eating behaviours, children's exclusion diets need to be as varied as possible and reintroduction of cows' milk products closely monitored.

Health-related quality of life in children with perceived and diagnosed food hypersensitivity.

BACKGROUND: The few studies measuring health-related quality of life (HRQL) in food hypersensitivity (FHS) have found significantly reduced HRQL in patients and their families, particularly in the areas of family and social activities, emotional issues and family economy. One aspect that has not been studied is the effect of suspected FHS (food allergy/intolerance) vs. diagnosed FHS [based on a food challenge or a positive skin prick test (SPT) and good clinical history] on HRQL. Therefore, the aim of this study was to investigate the HRQL in children with a proven diagnosis of FHS vs. those with reported FHS. METHODS: We have utilized the 10-yr old follow-up cohort of the Food Allergy and Intolerance Research (FAIR) study from the Isle of Wight and assessed the child's HRQL with the Food Allergy Quality of Life Questionnaire-Parent Form (FAQLQ-PF) which measures HRQL using four domains: food anxiety, emotional impact, social and dietary limitation. RESULTS: When comparing the two groups of children (proven FHS vs. perceived FHS), no difference in HRQL was found, although food anxiety showed a p-value of (p = 0.062). This was also the case when correcting for all confounding factors identified. CONCLUSION: We have found that having a clear diagnosis of FHS is not an independent predictor of HRQL. Future studies are required comparing two more similar groups. We also need to focus more on the effect of continuous input from the multidisciplinary team on HRQL and which particular factors of FHS management affect HRQL.

Information and support from dietary consultation for mothers of children with food allergies.

BACKGROUND: Professional dietetic input is essential to ensure that children with diagnosed food allergies have an individualized avoidance plan and nutritionally adequate diet. However, it is not clear what dietary information and support parents require. OBJECTIVE: To explore what information and support parents of children with food allergies require from a dietary consultation. METHODS: Focus groups were conducted with 17 mothers who attend an allergy center for dietary advice for their food allergic child. A number of issues around food allergy dietary advice needs were explored and analyzed using thematic analysis. RESULTS: Six themes were identified. The mothers described how they sought to protect their child from harm, to maintain normality for their child, and to promote child independence. They described needing to become an expert in their child's food allergy and fight their corner when needed. The dietitian supported their needs by ensuring their child's diet was safe and nutritionally adequate and giving information and support to help them provide a normal life for their child. Dietitians also taught mothers about food allergy and provided advocacy and emotional support. CONCLUSION: Mothers of children with food allergies want to understand how to provide a nutritionally adequate, allergen-safe diet while maintaining a normal life. Hence, mothers value a range of support from dietitians, including monitoring their child's health and providing information, practical advice and support, and emotional support.

What does adolescent undiagnosed wheeze represent? Findings from the Isle of Wight Cohort.

We sought to characterise adolescent wheeze in the absence of asthma, which we termed "undiagnosed wheeze". The Isle of Wight Birth Cohort (n=1,456) was reviewed at 1, 2, 4, 10 and 18 yrs. Using questionnaire responses, "asthma" was defined as "ever had asthma" plus either "wheezing in the last 12 months" or "taking asthma treatment in the last 12 months"; "undiagnosed wheeze" as "wheeze in the last 12 months" but "no" to "ever had asthma"; and remaining subjects termed "non-wheezers". Undiagnosed wheeze (prevalence 4.9%) accounted for 22% of wheezing at 18 yrs. This was largely adolescent-onset with similar symptom frequency and severity to diagnosed asthma. However, undiagnosed wheezers had significantly higher forced expiratory volume in 1 s to forced vital capacity ratio, less bronchodilator reversibility and bronchial hyperresponsiveness, and were less frequently atopic than asthmatics. Undiagnosed wheezers had earlier smoking onset, higher smoking rates and monthly paracetamol use than non-wheezers. Logistic regression identified paracetamol use (OR 1.11, 95% CI 1.01-1.23; p=0.03), smoking at 18 yrs (OR 2.54, 95% CI 1.19-5.41; p=0.02), rhinitis at 18 yrs (OR 2.82, 95% CI 1.38-5.73; p=0.004) and asthmatic family history (OR 2.26, 95% CI 1.10-4.63; p=0.03) as significant independent risk factors for undiagnosed wheeze. Undiagnosed wheeze is relatively common during adolescence, differs from diagnosed asthma and has strong associations with smoking and paracetamol use. Better recognition of undiagnosed wheeze and assessment of potential relevance to adult health is warranted.

Influence of atopy and asthma on exhaled nitric oxide in an unselected birth cohort study.

BACKGROUND: Asthma is considered to be associated with elevated levels of exhaled nitric oxide (FeNO). The nature of this relationship and how it is influenced by atopy are still not resolved. METHODS: The Isle of Wight birth cohort (N=1456) was reassessed at 18 years of age. Participants able to attend the research centre were assessed by questionnaires, skin prick testing and FeNO in order to explore the interrelationship between asthma, atopy and FeNO. RESULTS: Atopy was significantly associated with higher levels of FeNO. However, the level of FeNO for non-atopic asthmatic participants was no different to the non-atopic no-asthma group. The highest levels of FeNO were seen in subjects with both atopy and asthma. In addition, FeNO was positively associated with increasing atopic burden as evidenced by increasing FeNO with increasing skin prick testing positivity, and with increasing severity of atopic asthma as evidenced by the number of attacks of wheezing. FeNO and current inhaled corticosteroid use were not significantly associated. CONCLUSIONS: FeNO behaves as a biomarker of atopy and the "allergic asthma" phenotype rather than asthma itself. This may explain why FeNO-guided asthma treatment outcomes have proved to be of limited success where atopic status has not been considered and accounted for.

Are exhaled nitric oxide measurements using the portable NIOX MINO repeatable?

BACKGROUND: Exhaled nitric oxide is a non-invasive marker of airway inflammation and a portable analyser, the NIOX MINO (Aerocrine AB, Solna, Sweden), is now available. This study aimed to assess the reproducibility of the NIOX MINO measurements across age, sex and lung function for both absolute and categorical exhaled nitric oxide values in two distinct groups of children and teenagers. METHODS: Paired exhaled nitric oxide readings were obtained from 494 teenagers, aged 16-18 years, enrolled in an unselected birth cohort and 65 young people, aged 6-17 years, with asthma enrolled in an interventional asthma management study. RESULTS: The birth cohort participants showed a high degree of variability between first and second exhaled nitric oxide readings (mean intra-participant difference 1.37 ppb, 95% limits of agreement -7.61 to 10.34 ppb), although there was very close agreement when values were categorised as low, normal, intermediate or high (kappa = 0.907, p < 0.001). Similar findings were seen in subgroup analyses by sex, lung function and asthma status. Similar findings were seen in the interventional study participants. CONCLUSIONS: The reproducibility of exhaled nitric oxide is poor for absolute values but acceptable when values are categorised as low, normal, intermediate or high in children and teenagers. One measurement is therefore sufficient when using categorical exhaled nitric oxide values to direct asthma management but a mean of at least two measurements is required for absolute values.

Factors associated with maternal dietary intake, feeding and weaning practices, and the development of food hypersensitivity in the infant.

Maternal diet during pregnancy and breastfeeding, as well as infant feeding and weaning practices, may play a role in the development of sensitization to food and food hypersensitivity (FHS) and need further investigation. Pregnant women were recruited at 12 wk pregnancy. Information regarding family history of allergy was obtained by means of a questionnaire. A food frequency questionnaire was completed at 36 wk gestation. Information regarding feeding practices and reported symptoms of atopy was obtained during the infants' first 3 yr of life. Children were also skin-prick tested at 1, 2 and 3 yr to a pre-defined panel of food allergens. Food challenges were conducted where possible. Maternal dietary intake during pregnancy, and breast-feeding duration did not influence the development of sensitization to food allergens or FHS, but weaning age (>or=16 wk) did for sensitization at 1 yr (p = 0.03), FHS by 1 yr (p = 0.02), sensitization at 3 yr (p = 0.01) and FHS by 3 yr (p = 0.02). In contrast, children who were not exposed to a certain food allergen before the age of 3-6 months were less likely to become sensitized or develop FHS. Women with a family history of allergic disease were more likely to breastfeed exclusively at 3 months (p = 0.008) and avoid peanuts from the infant's diet at 6 months (p = 0.03). Maternal dietary intake during pregnancy, and breast-feeding duration did not appear to influence the development of sensitization to food allergens or FHS. Weaning age may affect sensitization to foods and development of FHS. A history of allergic disease has very little impact on maternal dietary, feeding, and weaning practices.

Patterns of sensitization to food and aeroallergens in the first 3 years of life.

BACKGROUND: There is a paucity of longitudinal studies of allergen sensitization in childhood. OBJECTIVE: To investigate the pattern of sensitization in early childhood. METHODS: A nested cohort of children (n = 543) were followed up from birth and given a skin prick test (SPT) at 1, 2, and 3 years of age. A detailed clinical history was obtained. RESULTS: The prevalences of sensitization to aeroallergens were 1.3%, 6.4%, and 10.7% at 1, 2, and 3 years of age. The figures for food allergens were 2.8%, 3.9%, and 3.7%. There was a statistically significant increase in the prevalence of sensitization to >or=1 allergen between years 1 and 2 (P < .001) and years 2 and 3 (P = .032). Among those with a positive SPT at 1 year, 29% tested positive to additional allergens at 2 years (P = .0054). Sensitization to milk or egg at 1 year was a predictor for increased sensitization to peanut at 3 years (odds ratio, 34.8; P < .0001). Sensitization to egg at 1 year was associated with increased sensitization to aeroallergens at 3 years (odds ratios, house dust mite, 27.1, P < .001; cat, 8.9, P < .01; grass, 11.8, P = .005). For peanut and cat allergens, wheal size increases with the age of the child (P = .009 and P = .017, respectively). CONCLUSION: Sensitization to allergens as demonstrated by positive SPT tends to increase with age, and this change can be detected in the first 3 years of life. CLINICAL IMPLICATIONS: The high predictive value for early sensitization and a linear increase in SPT reactivity provide an opportunity for early intervention.

Randomised controlled trial of silk therapeutic garments for the management of atopic eczema in children: the CLOTHES trial.

BACKGROUND: Atopic eczema (AE) is a chronic, itchy, inflammatory skin condition that affects the quality of life of children and their families. The role of specialist clothing in the management of AE is poorly understood. OBJECTIVES: To assess the effectiveness and cost-effectiveness of silk garments for the management of AE in children with moderate to severe disease. DESIGN: Parallel-group, observer-blind, randomised controlled trial of 6 months' duration, followed by a 2-month observational period. A nested qualitative study evaluated the beliefs of trial participants, health-care professionals and health-care commissioners about the use of silk garments for AE. SETTING: Secondary care and the community in five UK centres. PARTICIPANTS: Children aged 1-15 years with moderate or severe AE. INTERVENTIONS: Participants were randomised (1 : 1 using online randomisation) to standard care or standard care plus 100% silk garments made from antimicrobially protected knitted sericin-free silk [DermaSilkTM (AlPreTec Srl, San Donà di Piave, Italy) or DreamSkinTM (DreamSkin Health Ltd, Hatfield, UK)]. Three sets of garments were supplied per participant, to be worn for up to 6 months (day and night). At 6 months the standard care group received the garments to use for the remaining 2-month observational period. MAIN OUTCOME MEASURES: Primary outcome - AE severity using the Eczema Area and Severity Index (EASI) assessed at 2, 4 and 6 months, by nurses blinded to treatment allocation. EASI scores were log-transformed for analysis. Secondary outcomes - patient-reported eczema symptoms (Patient Oriented Eczema Measure); global assessment of severity (Investigator Global Assessment); quality of life of the child (Atopic Dermatitis Quality of Life, Child Health Utility - 9 Dimensions), family (Dermatitis Family Impact Questionnaire) and main carer (EuroQoL-5 Dimensions-3 Levels); use of standard eczema treatments (e.g. emollients, topical corticosteroids); and cost-effectiveness. The acceptability and durability of the clothing, and adherence to wearing the garments, were assessed by parental/carer self-report. Safety outcomes - number of skin infections and hospitalisations for AE. RESULTS: A total of 300 children were randomised (26 November 2013 to 5 May 2015): 42% female, 79% white, mean age 5 years. The primary analysis included 282 out of 300 (94%) children (n = 141 in each group). Garments were worn for at least 50% of the time by 82% of participants. Geometric mean EASI scores at baseline, 2, 4 and 6 months were 8.4, 6.6, 6.0, 5.4 for standard care and 9.2, 6.4, 5.8, 5.4 for silk clothing, respectively. There was no evidence of difference between the groups in EASI score averaged over all follow-up visits adjusted for baseline EASI score, age and centre (ratio of geometric means 0.95, 95% confidence interval 0.85 to 1.07; p = 0.43). This confidence interval is equivalent to a difference of -1.5 to 0.5 in the original EASI scale units. Skin infections occurred in 39 out of 141 (28%) and 36 out of 142 (25%) participants for standard care and silk clothing groups, respectively. The incremental cost per QALY of silk garments for children with moderate to severe eczema was £56,811 from a NHS perspective in the base case. Sensitivity analyses supported the finding that silk garments do not appear to be cost-effective within currently accepted thresholds. LIMITATIONS: Knowledge of treatment allocation may have affected behaviour and outcome reporting for some of the patient-reported outcomes. CONCLUSIONS: The addition of silk garments to standard AE care is unlikely to improve AE severity, or to be cost-effective compared with standard care alone, for children with moderate or severe AE. This trial adds to the evidence base to guide clinical decision-making. FUTURE WORK: Non-pharmacological interventions for the management of AE remain a research priority among patients. TRIAL REGISTRATION: Current Controlled Trials ISRCTN77261365. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 21, No. 16. See the NIHR Journals Library website for further project information.

Very low prevalence of IgE mediated wheat allergy and high levels of cross-sensitisation between grass and wheat in a UK birth cohort.

BACKGROUND: Patients often report adverse reactions to wheat. Interpretation of sensitization to wheat pollen and flour with/without sensitization to grass pollen is a clinical problem. AIM: We set out to determine the prevalence of wheat allergy in a birth cohort (10/11 year olds) and investigate the usefulness of performing skin prick tests (SPT), specific IgE tests and component resolved diagnostics to wheat pollen and flour. METHODS: The Food Allergy and Intolerance Research (FAIR) birth cohort included babies born on the Isle of Wight (UK) between September 2001-August 2002 (n = 969). Children were followed up at 1, 2, 3 and 10/11 years. 588 children had SPTs to wheat pollen and grass during the 10 year follow-up. 294 children underwent further SPT to wheat flour and 246 had specific IgE testing to wheat and grass. RESULTS: Eight children underwent oral food challenges (OFC). We diagnosed 0.48 % (4/827; 95 % CI 0-1 %) children with wheat allergy based on OFC. 16.3 % (96/588) were sensitized to grass pollen, 13.4 % (79/588) to wheat pollen; 78 % (75/96) sensitized to both. Only one child was sensitized to wheat flour and wheat pollen, but not grass pollen. For specific IgE, 15.0 % (37/246) and 36.2 % (89/246) were sensitized to wheat and grass pollen, with 40.5 % (36/89) sensitized to both. Of the 37 children sensitized to wheat, 3 (8.1 %) were sensitized to omega 5 gliadin, 1 (2.7 %) to wheat lipid transfer protein and 1 to wheat gliadin. CONCLUSION: Clinicians should be aware of the high level of cross-sensitization when performing tests to wheat and grass pollen i.e. sensitisation to wheat specific IgE and wheat pollen SPT should be assessed in the presence of grass pollen SPT and/or specific IgE.

Prevalence of sensitization reported and objectively assessed food hypersensitivity amongst six-year-old children: a population-based study.

There is a paucity of information on food hypersensitivity (FHS) in young children and there are even fewer population-based studies in this area. The aim of the study was to determine the prevalence of parentally reported FHS, and objectively diagnosed FHS amongst six-year-old children and to establish the rates of sensitization to key allergens. This population-based cohort study recruited 798 6-year-olds resident on the Isle of Wight (UK). Sensitization rates, reported rates of FHS and objectively assessed FHS was established using food challenges. A total of 94 (11.8%) 6 yr olds reported a problem with a food or food ingredient. The rate of sensitization to the pre-defined panel of food allergens was 25/700 (3.6%). Based on open food challenge and/or suggestive history and skin tests, the prevalence of FHS was 2.5% (95% CI 1.5-3.8). Based on double-blind challenges, a clinical diagnosis or suggestive history and positive skin tests, the prevalence was 1.6% (95% CI 0.9-2.7). The rates of perception of FHS are higher than the prevalence of sensitization to main food allergens and the prevalence of FHS based on food challenges. Milk, peanut and wheat were the key food allergens amongst those with positive challenges.

Incidence of parentally reported and clinically diagnosed food hypersensitivity in the first year of life.

BACKGROUND: There are very few population-based studies investigating the incidence of food hypersensitivity during the first year of life. OBJECTIVE: To determine the incidence of parentally reported food hypersensitivity and objectively diagnosed food hypersensitivity during the first year of life. METHODS: A birth cohort was recruited (n = 969). At 3, 6, 9, and 12 months, information regarding feeding practices and reported symptoms of atopy were obtained. At 1 year, infants underwent a medical examination and skin prick testing to a battery of allergens. Symptomatic infants underwent food challenges. RESULTS: Adverse reactions to foods were reported by 132 (14.2%) parents at 3, 83 (9.1%) at 6, 49 (5.5%) at 9, and 65 (7.2%) at 12 months. Of the subjects, 1.0% (8/763) were sensitized to aeroallergens and 2.2% (17/763) to food allergens. Between 6 and 9 months and 9 and 12 months, 1.4% (14/969) and 2.8% (27/969) infants were diagnosed with food hypersensitivity on the basis of open food challenges and 0.9% (9/969) and 2.5% (24/969) on the basis of double-blind, placebo-controlled food challenges. Cumulative incidence of food hypersensitivity by 12 months was 4% (39/969; 95% CI, 2.9% to 5.5%) on the basis of open food challenges and 3.2% (31/969; 95% CI, 2.2% to 4.5%) on the basis of double-blind, placebo-controlled food challenges. CONCLUSION: Between 2.2% and 5.5% of infants have food hypersensitivity in the first year of life. The rate of parental perception of food hypersensitivity is higher than the prevalence of atopic sensitization to main food allergens or objectively assessed food hypersensitivity. CLINICAL IMPLICATIONS: In the first year of life, the rate of parentally perceived food hypersensitivity is considerably higher than objectively assessed food hypersensitivity.

Prevalence of sensitization to food allergens, reported adverse reaction to foods, food avoidance, and food hypersensitivity among teenagers.

BACKGROUND: There is a paucity of information on food hypersensitivity (FHS) among teenagers. OBJECTIVES: We sought to investigate the sensitization rates, perception of FHS, food avoidance, and FHS assessed by means of food challenges among teenagers. METHODS: This cohort study recruited 757 eleven-year-olds and 775 fifteen-year-olds in the United Kingdom. Sensitization rates, reported rates of FHS, and rates of food avoidance were measured. The prevalence of FHS was established by using food challenges. RESULTS: The prevalence of reported FHS among the 11- and 15-year-old cohorts was 11.6% (90/775) and 12.4% (94/757), respectively. One hundred twenty-two (15.7%) and 142 (18.7%) of the 11- and 15-year-olds reported they were avoiding some food. The rates of sensitization to the food allergens were 5.1% (36/699) and 4.9% (32/649) for the 11- and 15-year-olds, respectively. FHS was confirmed in 8 (1.0%) 11-year-old children and 8 (1.0%) 15-year-old children by means of open food challenge and in 1 (0.1%) 11-year-old and 4 (0.5%) 15-year-olds by means of double-blind, placebo-controlled food challenge. The prevalence of FHS, as confirmed by using open food challenges and positive skin prick test responses plus a history of adverse reactions, was 18 (2.3%) of 775 in the 11-year-old cohort and 17 (2.3%) of 757 in the 15-year-old cohort. CONCLUSIONS: The rate of reported FHS was significantly more than sensitization to the predetermined allergens (odds ratio, 2.17; 95% CI, 1.47-3.18; P < .001 in the 11-year-olds; odds ratio, 2.73; 95% CI, 1.81-4.13; P < .001 in the 15-year-olds). By means of objective assessment, 2.3% of both 11- and 15-year-old children had FHS, with the majority showing immediate reactions.