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1.
Tolerance of soya lecithin in children with non-immunoglobulin E-mediated soya allergy: a randomised, double-blind, cross-over trial.
Gholmie, Y, Lozinsky, AC, Godwin, H, Reeve, K, Dzubiak, R, Shah, N, Meyer, R
Journal of human nutrition and dietetics : the official journal of the British Dietetic Association. 2020;(2):232-240
Abstract
BACKGROUND Soya lecithin is present in a wide variety of foods regularly consumed by children, in the form of an emulsifier or stabiliser. Children with non-immunoglobulin (Ig)E-mediated allergies who commonly have to avoid milk and soya will have a significantly restrictive diet with reduced alternative foods if soya lecithin also has to be eliminated. The present study aimed to establish whether children with non-IgE-mediated gastrointestinal soya allergy react to soya lecithin in food products. METHODS A double-blind, cross-over study was performed in soya-allergic children aged between 8 months and 5 years. Eligible children had their soya allergy status confirmed with a home challenge. Children were randomly assigned to either placebo or challenge dose of soya lecithin (1.5 g per day) in a custom-made biscuit. This was followed by a 1-week washout period and cross-over to another 1 week of challenge or placebo dose. Symptoms were recorded prior to commencing the study and at the end of each week's challenge. RESULTS Twenty-two children, 16 boys, with a median age of 44 months (range 21-58 months) were recruited, although only 20 completed the full study. The median number of foods avoided in addition to soya was 3. Over the challenge period, the parents reported reactions in six cases: five cases (23%) to the placebo and one case (5%) to the challenge dose. There was no statistical difference (P = 0.025) between the groups. CONCLUSIONS One child with a non-IgE-mediated gastrointestinal allergy had a slight reaction to soya lecithin. Although single cases may react to soya lecithin, we suggest that soya lecithin should be included in children with this delayed allergy, unless they have a confirmed reaction to traces of soya within this emulsifier.
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Skin emollient and early complementary feeding to prevent infant atopic dermatitis (PreventADALL): a factorial, multicentre, cluster-randomised trial.
Skjerven, HO, Rehbinder, EM, Vettukattil, R, LeBlanc, M, Granum, B, Haugen, G, Hedlin, G, Landrø, L, Marsland, BJ, Rudi, K, et al
Lancet (London, England). 2020;(10228):951-961
Abstract
BACKGROUND Skin emollients applied during early infancy could prevent atopic dermatitis, and early complementary food introduction might reduce food allergy in high-risk infants. The study aimed to determine if either regular skin emollients applied from 2 weeks of age, or early complementary feeding introduced between 12 and 16 weeks of age, reduced development of atopic dermatitis by age 12 months in the general infant population. METHODS This population-based 2×2 factorial, randomised clinical trial was done at Oslo University Hospital and Østfold Hospital Trust, Oslo, Norway; and Karolinska University Hospital, Stockholm, Sweden. Infants of women recruited antenatally at the routine ultrasound pregnancy screening at 18 weeks were cluster-randomised at birth from 2015 to 2017 to the following groups: (1) controls with no specific advice on skin care while advised to follow national guidelines on infant nutrition (no intervention group); (2) skin emollients (bath additives and facial cream; skin intervention group); (3) early complementary feeding of peanut, cow's milk, wheat, and egg (food intervention group); or (4) combined skin and food interventions (combined intervention group). Participants were randomly assigned (1:1:1:1) using computer- generated cluster randomisation based on 92 geographical living area blocks as well as eight 3-month time blocks. Carers were instructed to apply the interventions on at least 4 days per week. Atopic dermatitis by age 12 months was the primary outcome, based on clinical investigations at 3, 6 and 12 months by investigators masked to group allocation. Atopic dermatitis was assessed after completing the 12-month investigations and diagnosed if either of the UK Working Party and Hanifin and Rajka (12 months only) diagnostic criteria were fulfilled. The primary efficacy analyses was done by intention-to-treat analysis on all randomly assigned participants. Food allergy results will be reported once all investigations at age 3 years are completed in 2020. This was a study performed within ORAACLE (the Oslo Research Group of Asthma and Allergy in Childhood; the Lung and Environment). The study is registered at clinicaltrials.gov, NCT02449850. FINDINGS 2697 women were recruited between Dec 9, 2014, and Oct 31, 2016, from whom 2397 newborn infants were enrolled from April 14, 2015, to April 11, 2017. Atopic dermatitis was observed in 48 (8%) of 596 infants in the no intervention group, 64 (11%) of 575 in the skin intervention group, 58 (9%) of 642 in the food intervention group, and 31 (5%) of 583 in the combined intervention group. Neither skin emollients nor early complementary feeding reduced development of atopic dermatitis, with a risk difference of 3·1% (95% CI -0·3 to 6·5) for skin intervention and 1·0% (-2·1 to 4·1) for food intervention, in favour of control. No safety concerns with the interventions were identified. Reported skin symptoms and signs (including itching, oedema, exanthema, dry skin, and urticaria) were no more frequent in the skin, food, and combined intervention groups than in the no intervention group. INTERPRETATION Neither early skin emollients nor early complementary feeding reduced development of atopic dermatitis by age 12 months. Our study does not support the use of these interventions to prevent atopic dermatitis by 12 months of age in infants. FUNDING The study was funded by several public and private funding bodies: The Regional Health Board South East, The Norwegian Research Council, Health and Rehabilitation Norway, The Foundation for Healthcare and Allergy Research in Sweden-Vårdalstiftelsen, Swedish Asthma and Allergy Association's Research Foundation, Swedish Research Council-the Initiative for Clinical Therapy Research, The Swedish Heart-Lung Foundation, SFO-V at the Karolinska Institute, Freemason Child House Foundation in Stockholm, Swedish Research Council for Health, Working Life and Welfare-FORTE, Oslo University Hospital, the University of Oslo, and Østfold Hospital Trust.
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In "High-Risk" Infants with Sufficient Vitamin D Status at Birth, Infant Vitamin D Supplementation Had No Effect on Allergy Outcomes: A Randomized Controlled Trial.
Rueter, K, Jones, AP, Siafarikas, A, Lim, EM, Prescott, SL, Palmer, DJ
Nutrients. 2020;(6)
Abstract
Lower vitamin D status at birth and during infancy has been associated with increased incidence of eczema and food allergies. The aim of this study was to investigate the effect of early infancy vitamin D supplementation on allergic disease outcomes in infants at "hereditary risk" of allergic disease, but who had sufficient vitamin D levels at birth. Here, we report the early childhood follow-up to 2.5 years of age of "high-risk" infants who participated in a double-blinded, randomized controlled trial. For inclusion in this trial, late gestation (36-40 weeks) maternal 25-hydroxyvitamin D levels needed to be ≥50 nmol/L. Infants were randomized to either oral vitamin D supplementation of 400 IU/day (n = 97) or a placebo (n = 98) for the first six months of life. Vitamin D levels and allergic disease outcomes were followed up. There were no statistically significant differences in incidence of any medically diagnosed allergic disease outcomes or allergen sensitization rates between the vitamin D-supplemented and placebo groups at either 1 year or at 2.5 years of age. In conclusion, for "allergy high-risk" infants who had sufficient vitamin D status at birth, early infancy oral vitamin D supplementation does not appear to reduce the development of early childhood allergic disease.
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4.
Skin Care and Synbiotics for Prevention of Atopic Dermatitis or Food Allergy in Newborn Infants: A 2 × 2 Factorial, Randomized, Non-Treatment Controlled Trial.
Dissanayake, E, Tani, Y, Nagai, K, Sahara, M, Mitsuishi, C, Togawa, Y, Suzuki, Y, Nakano, T, Yamaide, F, Ohno, H, et al
International archives of allergy and immunology. 2019;(3):202-211
Abstract
BACKGROUND Atopic dermatitis (AD) and food allergy (FA) are common childhood diseases, which may either be interrelated or be the result of skin barrier disruption and gut mucosal dysbiosis. Although some evidence suggests the efficacy of emollients and synbiotics, there is no conclusive evidence on the use of these interventions alone or in combination. OBJECTIVES This study is aimed at identifying the efficacy of emollients and synbiotics in preventing AD and FA in children during the first year of life. METHODS The babies of mothers recruited prenatally received either an emollient, synbiotic, both or neither. The intervention was carried out from birth up to 6 months of age. The age of occurrence of AD and FA were reported in multiple questionnaires at 1, 6, and 9 months and at 1 year of age. AD was diagnosed by a pediatrician at 9 months of age. RESULTS A -total of 459 babies qualified for the outcome assessment at 1 year of age. Neither the emollient nor the synbiotic showed any effect on reducing the development of AD and FA at 1 year of age. CONCLUSIONS This study did not provide any evidence to show that emollients and synbiotics, alone or in combination are sufficient to prevent the occurrence of AD or FA in children up to 1 year of age.
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Treatment of Crohn's Disease with an IgG4-Guided Exclusion Diet: A Randomized Controlled Trial.
Gunasekeera, V, Mendall, MA, Chan, D, Kumar, D
Digestive diseases and sciences. 2016;(4):1148-57
Abstract
BACKGROUND AND AIM We previously reported an improvement in symptoms in Crohn's disease following an IgG4-guided exclusion diet in an open-label study. We aimed to evaluate, in a double-blinded randomized sham-controlled setting, the efficacy of IgG4-guided diet in improving quality of life in patients with Crohn's disease. METHODS Consecutive patients with Crohn's disease and a Crohn's disease activity index (CDAI) of 80-400 attending tertiary and secondary care centers were screened. All patients had IgG4 titers tested against 16 common food types using ELISA. The true diet group excluded four food types with the highest antibody titers for 4 weeks, and the sham group excluded four foods with the lowest antibody titers. Quality of life was assessed using the Short Inflammatory Bowel Disease Questionnaire (SIBDQ) at beginning and end of the trial. Secondary outcome measures were CDAI, Harvey Bradshaw index, serum C-reactive protein, and fecal calprotectin. RESULTS One hundred and forty-five subjects were screened and 96 subjects had initial food antibody testing performed with 76 patients completing the study. Milk, beef, pork and egg were the most commonly excluded food types in the true diet group. There was a 3.05 (0.01-6.11) p < 0.05 improvement in SIBDQ and 41 (10.4-71.5) in CDAI p = 0.009. CONCLUSION IgG4-guided exclusion diet, as an adjunct, can improve quality of life and symptoms in patients with CD.
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VITALITY trial: protocol for a randomised controlled trial to establish the role of postnatal vitamin D supplementation in infant immune health.
Allen, KJ, Panjari, M, Koplin, JJ, Ponsonby, AL, Vuillermin, P, Gurrin, LC, Greaves, R, Carvalho, N, Dalziel, K, Tang, ML, et al
BMJ open. 2015;(12):e009377
Abstract
INTRODUCTION Postnatal vitamin D supplementation may be associated with a reduction in IgE-mediated food allergy, lower respiratory tract infections and improved bone health. Countries in the Northern hemisphere recommend universal infant vitamin D supplementation to optimise early vitamin D levels, despite the absence of large trials proving safety or efficacy for any disease outcome. With the aim of determining the clinical and cost-effectiveness of daily vitamin D supplementation in breastfed infants from age 6-8 weeks to 12 months of age, we have started a double-blind, randomised, placebo-controlled trial of daily 400 IU vitamin D supplementation during the first year of life, VITALITY. METHODS ND ANALYSIS Infants (n=3012) who are fully breastfed and not receiving vitamin D supplementation will be recruited at the time of their first immunisation, from council-led immunisation clinics throughout metropolitan Melbourne, Australia. The primary outcome is challenge-proven food allergy at 12 months of age. Secondary outcomes are food sensitisation (positive skin prick test), number of lower respiratory infections (through hospital linkage), moderately-severe and persistent eczema (by history and examination) and vitamin D deficiency (serum vitamin D <50 nmol/L) at age 12 months. The trial is underway and the first 130 participants have been recruited. ETHICS AND DISSEMINATION The VITALITY study is approved by the Royal Children's Hospital (RCH) Human Research Ethics Committee (#34168). Outcomes will be disseminated through publication and will be presented at scientific conferences. TRIAL REGISTRATION NUMBERS ANZCTR12614000334606 and NCT02112734; pre-results.
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Introduction of potentially allergenic foods in the infant's diet during the first year of life in five European countries.
Schiess, SA, Grote, V, Scaglioni, S, Luque, V, Martin, F, Stolarczyk, A, Vecchi, F, Koletzko, B, ,
Annals of nutrition & metabolism. 2011;(2):109-17
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Abstract
BACKGROUND Little information is available on infants' age at first introduction of potentially allergenic foods as part of complementary feeding. We aimed to analyze age at the introduction of potentially allergenic foods in healthy term infants relative to recommendations in 5 European countries. METHOD Recruitment was conducted from October 2002 to June 2004. A total of 1,678 infants [588 breastfed (BF) and 1,090 formula-fed (FF) infants] were studied. In 1,368 infants, at least one 3-day weighed food diary at the age of 1-9 and 12 completed months was available. RESULTS Six percent of BF infants and 13% of FF infants consumed some potentially allergenic food already prior to the recommended minimum age of 4 months, and 4% of BF infants and 11% of FF infants had already received gluten. There were significant differences in the timing of the introduction of potentially allergenic foods between the countries at the age of 4-6 months (p < 0.001). CONCLUSION The time of first introduction of potentially allergenic foods in infants differed significantly between countries, and they were introduced much earlier than recommended in some countries. FF infants received potentially allergenic foods earlier than BF infants. Better information and counseling of parents is desirable.
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Ready-to-use introduction schedules for first exposure to allergenic foods in children at home.
Vlieg-Boerstra, BJ, Dubois, AE, van der Heide, S, Bijleveld, CM, Wolt-Plompen, SA, Oude Elberink, JN, Kukler, J, Jansen, DF, Venter, C, Duiverman, EJ
Allergy. 2008;(7):903-9
Abstract
BACKGROUND The vast majority of children will undergo their first exposure to common allergenic foods at home. However, the first exposure may lead to clinical reactions. It has been proposed to introduce allergenic foods gradually into the diets of children at risk for food allergy, but no practical dietary advice has been devised. OBJECTIVE The aim of this study was to devise safe introduction schedules for common allergenic foods for use at home, based on the challenge doses as administered in double-blind, placebo-controlled food challenge (DBPCFCs) in children who were never exposed previously to these foods. METHODS Seventy-two DBPCFCs were performed in 63 children as a first known exposure. The incrementing challenge doses were converted into equivalent portions of these foods in their usual household form and incorporated in introduction schedules. The feasibility of the introduction scales was tested in parents of the children attending our clinic. RESULTS Based on the results of the positive challenges (37) in which severe reactions did not occur, detailed introduction schedules and a reference photograph of the required increasing amounts of food were devised for use at home. Feasibility testing showed that, when using these introduction schedules, parents portioned the initial doses significantly lower than without detailed instructions. CONCLUSIONS The introduction schedules and reference photograph provide information for parents to introduce the required amounts of allergenic foods in initial low doses at home. This is expected to improve the safety of this procedure.
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Probiotic supplementation for the first 6 months of life fails to reduce the risk of atopic dermatitis and increases the risk of allergen sensitization in high-risk children: a randomized controlled trial.
Taylor, AL, Dunstan, JA, Prescott, SL
The Journal of allergy and clinical immunology. 2007;(1):184-91
Abstract
BACKGROUND Despite preliminary evidence, the role of probiotics in allergy prevention is unclear. OBJECTIVE To determine whether early probiotic supplementation prevents allergic disease in high-risk infants. METHODS Newborns of women with allergy (n = 231) received either Lactobacillus acidophilus (LAVRI-A1) or placebo daily for the first 6 months of life. Children were assessed for atopic dermatitis (AD) and other symptoms at 6 and 12 months and had allergen skin prick tests (SPT) at 12 months of age. RESULTS A total of 178 infants completed the supplementation period. Those in the probiotic group showed significantly higher rates of Lactobacillus colonization (P = .039). At 6 months, AD rates were similar in the probiotic (n = 23/89; 25.8%) and placebo (n = 20/88; 22.7%) groups (P = .629). There was also no difference at 12 months, although the proportion of children with SPT+AD was significantly higher in the probiotic group (P = .045). At 12 months, the rate of sensitization was significantly higher in the probiotic group (P = .030). The presence of culturable Lactobacilli or Bifidobacterium in stools in the first month of life was not associated with the risk of subsequent sensitization or disease; however, the presence of Lactobacillus at 6 months of age was associated with increased risk of subsequent cow's milk sensitization (P = .012). CONCLUSION Early probiotic supplementation with L acidophilus did not reduce the risk of AD in high-risk infants and was associated with increased allergen sensitization in infants receiving supplements. The long-term significance of the increased rate of sensitization needs to be investigated in further studies. CLINICAL IMPLICATIONS These findings challenge the role of probiotics in allergy prevention.
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A mutant of the major apple allergen, Mal d 1, demonstrating hypo-allergenicity in the target organ by double-blind placebo-controlled food challenge.
Bolhaar, ST, Zuidmeer, L, Ma, Y, Ferreira, F, Bruijnzeel-Koomen, CA, Hoffmann-Sommergruber, K, van Ree, R, Knulst, AC
Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology. 2005;(12):1638-44
Abstract
BACKGROUND Allergen-specific immunotherapy for food allergy has been hindered by severe side-effects in the past. Well-characterized hypo-allergenic recombinant food allergens potentially offer a safe solution. OBJECTIVE To demonstrate hypo-allergenicity of a mutated major food allergen from apple, Mal d 1, in vitro and in vivo. METHODS A mutant of the major apple allergen, Mal d 1, was obtained by site-directed mutagenesis exchanging five amino acid residues. Fourteen patients with combined birch pollen-related apple allergy were included in the study. Hypo-allergenicity of the mutant rMal d 1 (rMal d 1mut) compared with rMal d 1 was assessed by in vitro methods, i.e. RAST (inhibition), immunoblotting and basophil histamine release (BHR) and in vivo by skin prick test and double-blind placebo-controlled food challenge (DBPCFC). RESULTS RAST analysis (n = 14) revealed that IgE reactivity to rMal d 1mut was twofold lower than that of the wild-type molecule (95% confidence interval (CI): 1.7-2.4). RAST inhibition (n = 6) showed a 7.8-fold decrease in IgE-binding potency (95% CI: 3.0-12.6). In contrast to this moderate decrease in IgE-binding potency, the biological activity of rMal d 1mut assessed by SPT and BHR decreased 10-200-fold. Hypo-allergenicity was confirmed by DBPCFC (n = 2) with both recombinant molecules. CONCLUSION A moderate decrease in IgE-binding potency translates into a potent inhibition of biological activity. This is the first study that confirms by DBPCFC that a mutated recombinant major food allergen is clinically hypo-allergenic. This paves the way towards safer immunotherapy for the treatment of food-allergic patients.