Cow's Milk Allergy Clinical Trial
Official title:
Epigenetic Effects Involved in Children With Cow's Milk Allergy: A Possible Effect of Atopic March of Lactobacillus GG (EPICMA)
Verified date | March 2018 |
Source | Federico II University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Lactobacillus GG (LGG) is able to exert long lasting effects in children with atopic
disorders. Nutramigen LGG accelerates tolerance acquisition in infants with cow's milk
allergy. The mechanisms of these effects are still largely undefined. The effect of LGG could
be related at least in part by the immunoregulatory role played by LGG. This probiotic can
balance the generation of cytokines possibly involved in IgE- or non-IgE-mediated cow's milk
allergy Interleulkin (IL)-4, IL-5, IL-10, IFN-γ , TGF-β, and TNF-Υ), which can contribute to
modulation of inflammatory processes. The investigators have demonstrated that children with
IgE-mediated CMA produce significantly higher level of IL-4 and IL-13 in response to cow's
milk protein, and that tolerance is associated with a marked reduction of IL-13 production
and a concomitant increased frequency of IFN-γ releasing cells.
Epigenetics studies the heritable (and potentially reversible) changes of the genome
inherited from one cell generation to the next which alter gene expression but do not involve
changes in primary DNA sequences, highlighting the complexity of the inter-relationship
between genetics and nutrition. There are three distinct, but closely interacting, epigenetic
mechanisms (histone acetylation, DNA methylation, and non-coding microRNAs) that are
responsible for modifying the expression of critical genes associated with physiologic and
pathologic processes. The profile of epigenetic modifications associated with Th lineage
commitment, coupled with the sensitivity of the early developmental period, has led to
speculation that factors that disrupt these pathways may increase the risk of allergic
diseases. Specifically, effects on DNA methylation and endogenous histone deacetylase
inhibitors acting on specific pathways (Th1 and T regulatory cell differentiation) may favour
Th2-associated allergic differentiation. MicroRNAs are another structural components of an
epigenetic mechanism of post-transcriptional regulation of messenger RNA translation. It has
been recently identified a specific Th2-associated microRNA (miR-21) that is critical for the
regulation of Th cell polarization. It has been previously demonstrated an inverse DNA
methylation pattern of cytokines involved in Th2 response (IL-4, IL-5) compared with
cytokines involved in Th1 response (IL-10, INF- y) in children with CMA acquiring oral
tolerance, with the most pronounced effects in those treated with Nutramigen LGG. The current
study will prospectively evaluate the effect of Nutramigen LGG and other commercially
available hypoallergenic formulas on epigenetic mechanisms that may be related to tolerance
acquisition.
Status | Completed |
Enrollment | 20 |
Est. completion date | December 2017 |
Est. primary completion date | December 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Months to 12 Months |
Eligibility |
Inclusion Criteria: children with cow's milk allergy Exclusion Criteria: - Concomitant chronic systemic diseases, - congenital cardiac defects, - active tuberculosis, - autoimmune diseases, - immunodeficiency, - chronic inflammatory bowel diseases, - celiac disease, - cystic fibrosis, - metabolic diseases, - malignancy, - chronic pulmonary diseases, - malformations of the gastrointestinal tract, - suspected eosinophilic esophagitis or eosinophilic enterocolitis, - suspected food-protein-induced enterocolitis syndrome, - suspected cow's milk protein-induced anaphylaxis, - still on exclusion diet with one of the study formulas or with another dietary regimen because of cow's milk allergy, - other food allergies. |
Country | Name | City | State |
---|---|---|---|
Italy | University of Naples Federico II | Naples |
Lead Sponsor | Collaborator |
---|---|
Federico II University |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 12 months | |
Primary | Epigenetic modifications in cytokines genes | Methylation rate (%) of interleukin 4, interleukin 5, interleukin 10, interferon gamma, FOXP3 in children with cow's milk allergy | 12 months | |
Secondary | microRNAs modifications | Expression of miR106a, miR126, miR21, miR145, miR27a, miR29a/b, miR155, miR146a, miR128 | 12 months |
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