An observational study in Allergy Milk, Allergy;Food and Allergic Asthma, sponsored by Federico II University. Completed at 1 site in Italy. Open to participants aged 1 Month to 12 Months. Per ClinicalTrials.gov, last updated 2024-06-26.
Sponsored by Federico II University · Observational
Food allergy is a common chronic condition in childhood. Recent studies have suggested that the natural history of food allergy has changed during the last two decades, with an increased prevalence, severity of clinical manifestations, and risk of persistence into later ages. The increased food allergy prevalence in children has an important economic impact, with significant direct costs for the healthcare system and even larger costs for the families of food-allergic patients. In addition, children with food allergies are at increased risk to develop other allergic manifestations later in life. According to a recent study, children with a food allergy are 2 to 4 times more likely to develop other atopic manifestations such as asthma (4.0 times), atopic eczema (2.4 times), and respiratory allergies (3.6 times), compared to children without a food allergy. Cow's milk allergy is among the most common food allergy in early childhood, with an estimated prevalence of 2% to 3%. It has been previously showed that in children with cow milk allergy, an extensively hydrolysed casein formula supplemented with the probiotic Lactobacillus rhamnosus GG induced higher tolerance rates compared to extensively hydrolysed casein formula without Lactobacillus rhamnosus GG and other formulas. These findings were consistent with those of a 1-year follow-up study performed in the US that showed better outcomes using an extensively hydrolysed casein formula+Lactobacillus rhamnosus GG vs. an extensively hydrolysed casein formula or amino acid-based formula for the first-line dietary management of cow milk allergy. In addition it has been recently demonstrated that extensively hydrolysed casein formula + Lactobacillus rhamnosus GG reduces the incidence of other atopic manifestations and hastens the development of oral tolerance in children with IgE-mediated cow milk allergy.
The present randomized controlled trial (RCT) was designed to test whether different dietary interventions could influence the occurrence of other atopic manifestations in children with IgE-mediated cow milk allergy.
147 studies on the registry are indexed under Milk Hypersensitivity; 26 are open to participants now.
This study's enrollment of 365 is above the median of 102 across 45 observational studies indexed under Milk Hypersensitivity.
Browse Milk Hypersensitivity studies →Federico II University is the lead sponsor of 366 studies on the registry; 61 are open to participants now.
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Children who were consecutively observed at a FP office because the recent occurrence of signs and symptoms possibly related to IgE-mediated CMA were sent to our tertiary centre for paediatric allergy for possible inclusion in the study. Only subjects who met the inclusion criteria will be invited to participate to the study.Written informed consent will be obtained from the parents of each subject. Anamnestic, demographic, anthropometric and clinical data, as well as information on socio-demographic factors, family and living conditions, parental history of allergic diseases, maternal smoking during pregnancy, environmental tobacco smoke exposure, number of siblings, and pet ownership were obtained from the parents and recorded in a clinical database. For children with sure diagnosis of IgE-mediated CMA during a 3-year follow-up,3 visits every 12 months will be performed. Stool samples for metagenomics and metabolomics and blood sample for epigenetics studies will be collected.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
subjects with IgE mediated cow milk allergy treated with extensively hydrolyzed casein formula plus Lactobacillus rhamnosus GG as exclusion diet
Dietary Supplement: hypoallergenic formulas
subjects with IgE mediated cow milk allergy treated with extensively hydrolyzed whey formula as exclusion diet
Dietary Supplement: hypoallergenic formulas
subjects with IgE mediated cow milk allergy treated with hydrolyzed rice formula as exclusion diet
Dietary Supplement: hypoallergenic formulas
subjects with IgE mediated cow milk allergy treated with soy based formula as exclusion diet
Dietary Supplement: hypoallergenic formulas
subjects with IgE mediated cow milk allergy treated with amino-acid based formula as exclusion diet
Dietary Supplement: hypoallergenic formulas
hypoallergenic formulas used for cow milk allergy treatment
Rate of subjects with occurrence of other of allergic manifestations
To evaluate the effect of different dietary strategies on the occurrence of eczema, urticaria, asthma and rhinoconjunctivitis in children with IgE-mediated cow milk allergy
Time frame: 3 years
Rate of subjects with tolerance acquisition to cow's milk
To evaluate the tolerance acquisition to cow's milk
Time frame: 3 years
Change in metagenomics and metabolomics
16S rRNA gene amplicon sequencing
Time frame: 3 years
Epigenetic modifications in cytokines genes
Serum levels (pg/ml) of interleukin 4, interleukin 5, interleukin 10, interferon gamma, FOXP3 in children with cow's milk allergy
Time frame: 3 years
Epigenetic modifications in cytokines genes
Methylation rate (%) of interleukin 4, interleukin 5, interleukin 10, interferon gamma, FOXP3 in children with cow's milk allergyFOXP3 in children with cow's milk allergy
Time frame: 3 years
Rate of subjects with occurrence of other of allergic manifestations
To evaluate the effect of different dietary strategies on the occurrence of eczema, urticaria, asthma and rhinoconjunctivitis in children with IgE-mediated cow milk allergy
Time frame: after 4 to 6 years follow-up
Rate of subjects with tolerance acquisition to cow's milk
To evaluate the tolerance acquisition to cow's milk
Time frame: after 4 to 6 years follow-up
Rate of subjects with any autoimmune disease
To evaluate the occurrence of type 1 diabetes, celiac disease, juvenile idiopathic arthritis, thyroiditis, inflammatory bowel diseases
Time frame: 6 years
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Dec 2014 to primary completion in May 2020, 65 months.
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This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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