Impact of early feeding on childhood eczema: development after nutritional intervention compared with the natural course - the GINIplus study up to the age of 6 years.

BACKGROUND: Nutritional intervention with hydrolysed infant formulas has been shown efficacious in preventing eczema in children predisposed to allergy. However, this preventive effect has never been related to the natural course of eczema in children with or without a family history of allergy. The aim of this study therefore was to compare the course of eczema in predisposed children after nutritional intervention to the natural course of eczema. METHOD: The prospective German birth cohort study GINIplus includes a total of 5991 children, subdivided into interventional and non-interventional groups. Children with a familial predisposition for allergy whose parents agreed to participate in the prospective, double-blind intervention trial (N=2252) were randomly assigned at birth to one of four formulas: partially or extensively hydrolysed whey, extensively hydrolysed casein (eHF-C) or standard cow's milk formula. Children with or without familial predisposition represented the non-interventional group (N=3739). Follow-up data were taken from yearly self-administered questionnaires from 1 up to 6 years. The outcome was physician-diagnosed eczema and its symptoms. The cumulative incidence of eczema in predisposed children with or without nutritional intervention was compared with that of non-predisposed children who did not receive intervention. Cox regression was used to adjust for confounding. RESULTS: Predisposed children without nutritional intervention had a 2.1 times higher risk for eczema [95% confidence interval (CI) 1.6-2.7] than children without a familial predisposition. The risk was smaller with nutritional intervention even levelling out to 1.3 (95% CI 0.9-1.9) in children fed eHF-C formula. CONCLUSION: Although direct comparability is somewhat restricted, the data demonstrate that early intervention with hydrolysed infant formulas can substantially compensate up until the age of 6 years for an enhanced risk of childhood eczema due to familial predisposition to allergy.

Safety and efficacy of a new extensively hydrolyzed formula for infants with cow's milk protein allergy.

Cow's milk protein allergy (CMPA) is best treated by complete elimination of cow's milk from the diet. For infants with CMPA who cannot be breast-fed, formulas based on extensively hydrolyzed proteins or on amino acids are the preferred substitutes for cow's milk-based formulas. In this study, we compared the tolerance and growth of infants with CMPA who were fed a new extensively hydrolyzed formula containing lactose (eHF) with those who were fed an amino acid formula (AAF). This was a prospective, multi-center, randomized, reference-controlled study. Seventy-seven infants <12 months old with suspected CMPA were enrolled. In 66 of these, CMPA was confirmed by oral challenge in a double-blind, placebo-controlled food challenge (DBPCFC) or by a medical history of severe allergic reaction to cow's milk and a positive skin prick test. These infants were then tested for their reaction to eHF and AAF in a DBPCFC. All infants tolerated both formulas and were randomized to receive either eHF (n = 34) or AAF (n = 32) for 180 days. Growth (weight, length, and head circumference) and tolerance [skin, gastro-intestinal, and respiratory tract symptoms of allergy] were evaluated after 30, 60, 90, and 180 days. There were no significant differences between the two groups in any of the growth measurements. Length and head circumference were similar to Euro-growth standards, but weight was slightly lower. Gastro-intestinal and respiratory tract symptoms of allergy were also similar in the two groups. However, whereas SCORAD scores for atopic dermatitis remained constant throughout the study in infants-fed eHF, there was a slight decrease in those fed AAF. Infants-fed eHF had significantly fewer incidents of vomiting than infants-fed AAF and a significantly higher frequency of soft stools. The new eHF is safe and well tolerated in infants diagnosed with CMPA.

European birth cohort studies on asthma and atopic diseases: II. Comparison of outcomes and exposures--a GA2LEN initiative.

BACKGROUND: The Global Allergy and Asthma European Network (GA2LEN) is a consortium of 26 leading European research centres committed to establish a European research area of excellence in the field of allergy and asthma. AIM: One of the GA2LEN work packages was designed to identify and compare the existing European birth cohort studies on asthma and atopic diseases. The present review compares their subjective and objective outcomes as well as exposure variables. METHODS: A common database was established to assess study characteristics of observational birth cohort studies designed to examine asthma and atopic diseases. Data were collected by visiting most of the participating research teams and interviewing all relevant study personnel. For each study, the type of objective/subjective outcome parameters and potentially influential factors were recorded precisely for every time point during follow-up. RESULTS: Eighteen birth cohort studies on asthma and atopic diseases were identified in eight European countries. Thirteen studies collected data on specific immunoglobulin E (IgE) to various inhalant and food allergens, whereas 12 performed skin prick tests (many at several time points during follow up). Several studies measured lung function, but across the cohorts no comparable standard procedures were used. For subjective evaluation of asthma and allergic rhinitis most studies applied the ISAAC questionnaire (sometimes modified), whereas the assessment of eczema was rather heterogeneous across the studies. CONCLUSION: This GA2LEN initiative established a unique common database of 18 European birth cohorts on asthma and atopic diseases. For selected cohorts, it seems that pooling data and performing common analyses may be possible to examine associations between certain exposure variables (e.g. pet ownership, tobacco smoke exposure and day-care) and selected outcome measures for atopy, asthma or allergic rhinitis (e.g. sensitization assessed by IgE or skin prick tests, doctor's diagnosis of asthma, parental perception regarding asthma/wheezing or hay fever symptoms).

European birth cohort studies on asthma and atopic diseases: I. Comparison of study designs -- a GALEN initiative.

BACKGROUND: The reasons for the rise in asthma and allergies remain unclear. To identify risk or protective factors, it is essential to carry out longitudinal epidemiological studies, preferably birth cohort studies. In Europe, several birth cohort studies on asthma and atopic diseases have been initiated over the last two decades. AIM: One of the work packages within the Global Allergy and Asthma European Network (GA(2)LEN) project was designed to identify and compare European birth cohorts on asthma and atopic diseases. The present review (part I) describes their objectives, study settings, recruitment process and follow-up rates. A subsequent review (part II) will compare outcome and exposure parameters. METHODS: For each birth cohort, we collected detailed information regarding recruitment process, study setting, baseline data (pregnancy, birth, parents/siblings) as well as follow-up rates, outcome and exposure parameters at each time point. RESULTS: We identified and assessed 18 European birth cohorts on asthma, allergic rhinitis and eczema. Six of these studies also focused on food allergies. The birth cohorts were mostly initiated in the 1990s with predominantly urban/metropolitan settings. Many studies were able to maintain high follow-up rates, even after five or more years. CONCLUSIONS: Due to the unique cooperation within the GA(2)LEN project a common database was established containing study characteristics of European birth cohorts on asthma and atopic diseases. This can be used as a basis for evaluating the possibility to pool data and perform meta-analyses, as well as to recommend criteria for conducting future birth cohorts.