Epigenetic Effects Elicited By Lactobacillus GG In Children With Cow's Milk Allergy
Primary Purpose
Cow's Milk Allergy
Status
Unknown status
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Lactobacillus GG
Sponsored by
About this trial
This is an interventional treatment trial for Cow's Milk Allergy
Eligibility Criteria
Inclusion Criteria:
- Children aged 4 months-4 years with cow's milk allergy
Exclusion Criteria:
- age higher than 4 years,
- 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.
Sites / Locations
- University of Naples Federico IIRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Treatment with Lactobacillus GG
Children at diagnosis
Arm Description
extensively hydrolyzed casein formula containing LGG
Outcomes
Primary Outcome Measures
Change from baseline to 6 months in tolerance acquisition and epigenetic effects in rtwenty children with cow's milk allergy
The investigators will evaluate in children with CMA if the effect of Lactobacillus GG on tolerance acquisition is mediated at least in part by an epigenetic mechanism.
Secondary Outcome Measures
Full Information
NCT ID
NCT02062476
First Posted
February 6, 2014
Last Updated
February 12, 2014
Sponsor
Federico II University
1. Study Identification
Unique Protocol Identification Number
NCT02062476
Brief Title
Epigenetic Effects Elicited By Lactobacillus GG In Children With Cow's Milk Allergy
Official Title
EPIGENETIC EFFECTS ELICITED BY LACTOBACILLUS GG IN CHILDREN WITH COW'S MILK ALLERGY: A POSSIBLE EFFECT OF ATOPIC MARCH
Study Type
Interventional
2. Study Status
Record Verification Date
February 2014
Overall Recruitment Status
Unknown status
Study Start Date
July 2013 (undefined)
Primary Completion Date
August 2014 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federico II University
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cow's Milk Allergy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment with Lactobacillus GG
Arm Type
Experimental
Arm Description
extensively hydrolyzed casein formula containing LGG
Arm Title
Children at diagnosis
Arm Type
No Intervention
Intervention Type
Dietary Supplement
Intervention Name(s)
Lactobacillus GG
Primary Outcome Measure Information:
Title
Change from baseline to 6 months in tolerance acquisition and epigenetic effects in rtwenty children with cow's milk allergy
Description
The investigators will evaluate in children with CMA if the effect of Lactobacillus GG on tolerance acquisition is mediated at least in part by an epigenetic mechanism.
Time Frame
Baseline, at least after 6 months of therapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Months
Maximum Age & Unit of Time
48 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Children aged 4 months-4 years with cow's milk allergy
Exclusion Criteria:
age higher than 4 years,
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Roberto Berni Canani, MD, PhD
Phone
0817462680
Facility Information:
Facility Name
University of Naples Federico II
City
Naples
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roberto Berni Canani
Phone
0817462680
12. IPD Sharing Statement
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Epigenetic Effects Elicited By Lactobacillus GG In Children With Cow's Milk Allergy
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