Real-life experience with hazelnut oral immunotherapy.

BACKGROUND: Hazelnut oral immunotherapy (H-OIT), a promising alternative to hazelnut-free diet for patients with hazelnut allergy, has not been extensively studied. OBJECTIVE: To investigate the effectiveness of H-OIT for children with hazelnut allergy. METHODS: Retrospective medical record review of children treated by H-OIT in the University Hospital of Lyon (France) was reported. Clinical and laboratory data were collected, and the satisfaction of the children treated by H-OIT was evaluated using a questionnaire. RESULTS: A total of 70 patients treated by H-OIT for an immunoglobulin E-mediated hazelnut allergy (94.3%) or an immunoglobulin E sensitization to hazelnut (5.7%) were included. Among these, 22.9% entered the maintenance phase at 1-year consultation and 60.0% entered the maintenance phase during the study period. At home, 57.1% of the patients experienced at least 1 adverse effect and 2.9% experienced severe systemic allergic reactions. Among the 212 oral food challenges conducted at hospital, 3.3% led to severe systemic reactions and epinephrine was used 4 times. A total of 21.4% of children discontinued treatment; aversion to hazelnut was the main reason. There were 42 children aged 8 years or more and their parents who answered the questionnaire. H-OIT was considered a strain for children but effective and was recommended to other children with allergy. CONCLUSION: H-OIT seemed to be effective and well accepted by children. This is counterbalanced by a high rate of H-OIT discontinuation, mainly owing to aversion to hazelnut, and an important rate of adverse reactions, which are however mostly mild. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04841850.

Hydrolyzed Rice Protein-Based Formulas, a Vegetal Alternative in Cow's Milk Allergy.

Formulas adapted to infant feeding, although most of the time made from cow's milk proteins, can be made from hydrolyzed rice protein but they must be classified as "formulas for specific medical needs", according to European regulations. The nutritional quality of rice proteins is thus suitable to be used in infant formulas giving that it is supplemented by certain amino acids which can be lacking. Besides, hydrolysis is required to facilitate their water solubility and digestibility. Owing to a low allergenicity of rice and to the absence of the cross-allergy between milk proteins and rice proteins, these formulas are adapted to the diet of children with cow's milk protein allergy (CMPA), which explains their growing use in some countries. However, CMPA, an expanding disorder, has consequences for growth, bone mineralization, and often has an association with allergy to other foods, including cow's milk extensive hydrolysate, so that a surveillance of the adaption of hydrolyzed rice protein formulas (HRPF) to CMPA, the absence of unexpected side effects, and the appropriate response to its various health hazards seems mandatory. This paper analyses the health problem deriving from CMPA, the industrial development of hydrolyzed rice protein formulas, and the limited number of clinical studies, which confirms, at the moment, a good allergic tolerance and safety. The goal is to better advise heath care professionals on their use of HRPFs during CMPA.

Randomized Trial of a Yogurt-type Amino Acid-based Formula in Infants and Children With Severe Cow's Milk Allergy.

OBJECTIVES: Evaluation of a spoon-fed amino acid-based formula (AAF) with a yogurt-type texture compared to the reference oral liquid formula (Neocate). METHODS: Phase III/IV, prospective, randomized (1:1), open-label, multicenter study in infants/young children (6-36 months) with severe cow's milk protein allergy (CMA) who had consumed AAF for ≥1 month before the study. Patients received reference+test formula (Neocate with a yogurt-type texture for spoon-feeding: group 1) or reference formula (group 2) for 28 days. The study formulae were integrated into the patients' usual daily diet. Efficacy on Day 0, 14, and 28 was assessed primarily in terms of symptoms associated with CMA. The evolution of symptoms, amount of formula consumed, nutritional and energy intake, anthropometric data, and tolerability were also assessed. RESULTS: The incidence of CMA symptoms was similar in each group (P > 0.05) on day 0, 14, and 28. For specific symptoms, there was little change from day 0 and no significant difference between groups for incidence on day 0 or evolution at day 14 or 28. There was no difference in formula consumption (day 0-day 28) between groups (P = 0.90), but nutritional value was generally higher for group 1 and calcium intake was statistically higher for group 1 (P < 0.05). Weight-for-height, weight-for age, and body mass index-for-age z scores were higher for group 1 than group 2 (P < 0.05). Both formulae were well tolerated. CONCLUSIONS: There was no difference in efficacy, formula consumption, and tolerability between the new spoon-fed yogurt-type AAF formula and the reference formula, whereas significantly higher calcium intake was achieved with the new formula.

Safety of a New Amino Acid Formula in Infants Allergic to Cow's Milk and Intolerant to Hydrolysates.

OBJECTIVES: Amino acid-based formulas (AAFs) are recommended for children with cow's-milk allergy (CMA) failing to respond to extensively hydrolysed formulas (eHFs). We evaluated the effects of a new thickened AAF (TAAF, Novalac), containing a pectin-based thickener, and a reference AAF (RAAF, Neocate) on allergy symptoms and safety, through blood biochemistry analysis and growth. METHODS: Infants (ages < 18 months) with CMA symptoms failing to respond to eHFs were randomised in a double-blind manner to receive TAAF or RAAF for 3 months. All of the infants were then fed TAAF for 3 additional months. Paediatric visits occurred at 1, 3, and 6 months. Blood samples were collected at inclusion and 3 months. RESULTS: Results at 1 month were previously described. The 75 infants with proven CMA and eHF intolerance tolerated their allocated formula. At 3 months, the dominant allergic symptom had disappeared in 76.2% of the infants with TAAF and in 51.5% of the infants with RAAF (P = 0.026). The Scoring Atopic Dermatitis Index significantly improved more with TAAF than with RAAF (-27.3 ±â€Š2.3 vs -20.8 ±â€Š2.2, P = 0.048). Of the infants, 92.9% had normal stools (soft or formed consistency) with TAAF vs 75.8% with RAAF (P = 0.051). More infants in TAAF group had better quality of nighttime sleep (P = 0.036) and low frequency of irritability signs (P < 0.001). With both formulas, all of the biochemical parameters were within normal ranges. There were no differences between the 2 groups in any of the anthropometric z scores. CONCLUSIONS: The new TAAF was tolerated by all of the infants with CMA and intolerance to eHFs. Anthropometric and clinical data showed that both formulas were safe.

A thickened amino-acid formula in infants with cow's milk allergy failing to respond to protein hydrolysate formulas: a randomized double-blind trial.

INTRODUCTION: Amino-acid-based formulas (AAFs) are recommended for children with cow's milk protein allergy (CMPA) failing to respond to extensively hydrolyzed formulas (eHFs). OBJECTIVE: This study aimed to assess the tolerance/hypoallergenicity and efficacy of a thickened AAF (TAAF) in these infants. METHODS: This multicenter, double-blind, randomized controlled trial (NCT01940068) compared 3-month feeding with a pectin-based TAAF (Novalac(®), United Pharmaceuticals, Paris, France) and a commercially available "reference" AAF (RAAF; Neocate(®), Nutricia, Germany) in infants aged <18 months with CMPA and persistent allergy symptoms with eHF feeding. Reported here are the results of an interim analysis after 1 month of feeding. RESULTS: Of the 86 infants randomized, CMPA with eHF intolerance was confirmed in 75 infants; all of them tolerated the allocated AAFs. The major allergic symptom disappeared within 1 month in 61.9 and 51.5 % and regurgitations disappeared in 66.7 and 42.3 % of infants who received TAAF and RAAF, respectively. Infants had significantly more normal stools (soft or formed consistency) with the TAAF (90.5 vs. 66.7 %; p = 0.011). From baseline, daily family life significantly improved with both AAFs: crying time decreased by 97.3 (p < 0.001) and 28.6 min (p = 0.014) and sleeping time increased by 64.6 (p = 0.009) and 29.0 min with TAAF and RAAF, respectively. At day 30, weight and body mass index z-score gains were 0.1 and 0.2 with TAAF and 0.2 and 0.0 with RAAF. CONCLUSION: Both AAFs were well tolerated by infants with CMPA and eHF intolerance and ensured appropriate growth, with the TAAF providing additional comfort.

Five-grass pollen 300IR SLIT tablets: efficacy and safety in children and adolescents.

The efficacy and safety of five-grass pollen 300IR sublingual immunotherapy (SLIT) tablets (Stallergènes SA, France) have previously been demonstrated in paediatric patients. This report presents additional data concerning efficacy at pollen peak, efficacy and safety according to age, nasal and ocular symptoms, use of rescue medication, satisfaction with treatment and compliance. Children (5-11 yr) and adolescents (12-17 yr) with grass pollen-allergic rhinoconjunctivitis were included in a multinational, randomized, double-blind, placebo-controlled study and received either a 300IR five-grass pollen tablet or placebo daily in a pre- (4 months) and co-seasonal protocol. The severity of six symptoms (sneezing, rhinorrhoea, nasal congestion, nasal and ocular pruritis, and tearing) was scored, and rescue medication use was recorded daily during the pollen season. Patient satisfaction was recorded at the season end. A total of 161 children and 117 adolescents were evaluated (n = 267). 300IR SLIT was effective over the whole season (p = 0.0010) and at the pollen peak (p = 0.0009). The adjusted mean difference between 300IR and placebo groups was significant for both nasal (p = 0.0183) and ocular (p < 0.0001) symptoms. Rescue medication use was statistically lower in the SLIT group during the pollen season and at the pollen peak (both p < 0.05). More patients in the SLIT group were satisfied with their treatment compared to placebo (83.2% vs. 68.1%, p = 0.0030), and compliance was high (SLIT 93.9% of patients were compliant, placebo 94.8% of patients were compliant). SLIT was well tolerated by children and adolescents. 300IR five-grass pollen tablets are effective and safe during the pollen season and at the pollen peak in children and adolescents with grass pollen rhinoconjunctivitis.

Influence of measles vaccination on the progression of atopic dermatitis in infants.

Atopic dermatitis (AD) is a chronic inflammatory skin disease, affecting 10-20% of children. Measles vaccination has been reported to have contradictory effects on incidence of AD in children. Therefore, we performed the first prospective, double-blind, placebo-controlled study to analyze the evolution of AD in infants after measles vaccination. The study included 12 infants (10-14 months old) with AD, randomly assigned to two groups: while the first group received a single dose of a standard measles vaccine ROUVAX, the second was treated with placebo (vehicle). Infants were followed-up for 6 months after administration of ROUVAX/placebo for the clinical signs associated with AD, by determination of SCORAD index. In addition, serum was taken before vaccination and 1 month later to determine the presence of seroconversion and to analyze the progression of serum levels of CCL18 (PARC) and E-selectin, known to be distinct serum markers that reflect clinical features of AD. In the vaccinated group, five of six children seroconverted 1 month after treatment and one infant showed a 50% improvement of SCORAD. Serum levels of CCL18 were significantly decreased in two treated infants (of four analyzed for this group) and E-selectin slightly decreased in one infant (of three analyzed by this test). In placebo-treated group the SCORAD improved in one patient and serum levels of CCL18 and E-selectin did not change. These data suggest that measles vaccination not only does not aggravate AD, but may also improve some of the immunological parameters of this allergic disease. Inclusion of a higher number of patients in a similar study should give a more comprehensive overview of the benefit of measles vaccination on the clinical evolution of AD patients, and potentially open new avenues to the clinical application of the anti-inflammatory effect of measles virus proteins.