Cow's Milk Allergy Clinical Trial
Official title:
EPIGENETIC EFFECTS ELICITED BY LACTOBACILLUS GG IN CHILDREN WITH COW'S MILK ALLERGY: A POSSIBLE EFFECT OF ATOPIC MARCH
Lactobacillus GG (LGG) is able to exert long lasting effects in children with atopic
disorders. We have shown that Nutramigen LGG accelerates tolerance acquisition in infants
with cow's milk allergy (CMA). 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 CMA (i.e., IL-4, IL-5, IL-10, IFN-γ , TGF-beta, and TNF-alfa), which can
contribute to modulation of inflammatory processes. We 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
miRNA (miR-21) that is critical for the regulation of Th cell polarization.
n/a
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02738060 -
The Effect of Baked Milk on Cow's Milk Allergy
|
Phase 2 | |
Recruiting |
NCT02149134 -
Evaluation of the Efficacy of a New Infant Formula in Subjects With Cow's Milk Allergy
|
Phase 2 | |
Recruiting |
NCT01891916 -
Effect Of Lactobacillus GG on Atopic March
|
N/A | |
Completed |
NCT01634490 -
Effects of Different Dietary Regimens on Tolerance Acquisition in Children With Cow's Milk Allergy
|
N/A | |
Completed |
NCT01622426 -
Tolerance to a New Free Amino Acid-based Formula in Children With IgE or Non-IgE-mediated Cow's Milk Allergy
|
N/A | |
Completed |
NCT02466035 -
Epigenetic Effects Involved in Children With Cow's Milk Allergy (EPICMA)
|
N/A | |
Completed |
NCT02379598 -
Effect of Therapy With Aminoacid Based Formula Versus Hydrolyzed Whey Proteins in Children With Cow's Milk Allergy
|
N/A | |
Completed |
NCT04330092 -
Diagnosis of Cow's Milk Protein Allergy
|
||
Not yet recruiting |
NCT02081651 -
Parmigiano-Reggiano Cheese as a Possible Strategy to Acquire Oral Tolerance in Children With Cow's Milk Allergy
|
Phase 3 | |
Completed |
NCT03462030 -
Baked Milk Oral Immunotherapy for Cow's Milk Allergy
|
Phase 2 | |
Completed |
NCT02465905 -
Oral Immunotherapy in Cow's Milk Allergy (CMA) in Children : "Petit Lait" Study
|
N/A | |
Suspended |
NCT05731206 -
Hypoallergenicity of a Hydrolyzed Protein Infant Formula
|
N/A | |
Not yet recruiting |
NCT06456541 -
Infant Formula in Infants and Children With Cow's Milk Allergy
|
N/A | |
Completed |
NCT01589731 -
Polymerized Beta-lactoglobulin Comparative Immunoreactivity
|
N/A | |
Terminated |
NCT02405923 -
Growth, Safety and Tolerance of a Rice Protein Hydrolysate Formula in Infants With Cow's Milk Protein Allergy
|
N/A | |
Terminated |
NCT04910373 -
Extensively Hydrolyzed Infant Formula in Infants and Children With Cow's Milk Allergy
|
N/A | |
Recruiting |
NCT01968278 -
Use of Baked Milk in Oral Immunotherapy for Severe IgE-mediated Cow's Milk Protein Allergic Patients
|
N/A | |
Withdrawn |
NCT01470768 -
Evaluation of Fatty Acid Levels and Growth in Infants Fed Amino Acid Based (AA) Formulas
|
N/A | |
Recruiting |
NCT05883384 -
Validity of Cow's Milk-related Symptom Score Among Children Suspected to Have Cow's Milk Protein Alergy
|
||
Completed |
NCT01901380 -
Cow's Milk Allergy and Functional Gastrointestinal Disorders
|
N/A |