Effect Of Lactobacillus GG on Atopic March
Primary Purpose
Cow's Milk Allergy, Atopic Disease
Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Extensively hydrolyzed casein formula + LGG
Sponsored by
About this trial
This is an interventional prevention trial for Cow's Milk Allergy
Eligibility Criteria
Inclusion Criteria:
- infants aged less than 12 months, with a diagnosis of cow's milk allergy
Exclusion Criteria:
- age higher than 12 months,
- 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 proteins-induced anaphylaxis
Sites / Locations
- University of Naples Federico IIRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
extensively hydrolysed casein formula
Extensively hydrolyzed casein formula + LGG
Arm Description
extensively hydrolysed casein formula
Extensively hydrolized formula plus LGG
Outcomes
Primary Outcome Measures
Occurrence of allergic manifestations
Occurrence of allergic manifestations in children with CMA including atopic eczema, allergic urticaria, asthma, allergic rhinitis.Information on social and demographic factors, family and living conditions, and smoking habits will be documented. Unscheduled visit will be made when possible allergic symptoms will appear. Every 12 months sensitization to common dietary and respiratory antigens will be assessed by skin prick tests (SPT) and prick by prick tests.
Secondary Outcome Measures
Allergic sensitization
Every 12 months sensitization to common dietary and respiratory antigens will be assessed by skin prick tests (SPT) and prick by prick tests.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01891916
Brief Title
Effect Of Lactobacillus GG on Atopic March
Official Title
Preventive Effect of Lactobacillus GG on Atopic Manifestation in Children With Cow's Milk Allergy
Study Type
Interventional
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Unknown status
Study Start Date
October 2008 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
December 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federico II University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Food allergy (FA), defined as an adverse immune response to food allergens, is among the most frequent allergic disorders in childhood and it has recognized as a major paediatric health problem due to the severity of the reactions and the dramatic increase over the past decades. Cow's milk allergy (CMA) is the most frequent FA in children worldwide, and it has been demonstrated that it could be the first manifestation of the so-called "atopic march", characterized by the occurrence of other allergic disorders in the subsequent years after the onset of CMA. In a previous study, involving children with CMA over a period of 5 years, 40% developed asthma, 21% atopic eczema, and 43% allergic rhinitis. Similar results have been reported in a recent study on Finnish children Intestinal microflora appears to have a crucial role in the development of atopic disorders. Children with atopic diseases have different commensal bacterial groups in the gut compared to non-atopic children, and differences are also found between countries with high and low incidence of atopic diseases. There is currently great interest in manipulating the normal microbiota to accrue health benefits through an approach known as "probiotics." Probiotics are defined as "live microorganisms which when administered in adequate amounts confer a health benefit on the host". The conceptual basis of possible use of probiotics in the prevention and treatment of atopic disorders is well grounded. Lactobacillus GG (LGG) is the most studied probiotic in the prevention and treatment of atopic disorders. Wide and well-designed clinical studies have provided several evidences on the efficacy of LGG as preventive or therapeutic strategy in pediatric atopic disorders. More recently, in vitro studies have provided evidences on the potent immunoregulatory role and on the influence on intestinal microflora composition (toward a more beneficial composition in the prevention and treatment of atopic disorders) elicited by LGG. This view has been further reinforced by recent research showing that LGG is able to improve recovery of intestinal symptoms in infants with CMA-induced allergic colitis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cow's Milk Allergy, Atopic Disease
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
extensively hydrolysed casein formula
Arm Type
No Intervention
Arm Description
extensively hydrolysed casein formula
Arm Title
Extensively hydrolyzed casein formula + LGG
Arm Type
Active Comparator
Arm Description
Extensively hydrolized formula plus LGG
Intervention Type
Dietary Supplement
Intervention Name(s)
Extensively hydrolyzed casein formula + LGG
Other Intervention Name(s)
Extensively hydrolyzed formula plus LGG
Intervention Description
Extensively hydrolyzed formula containing Lactobacillus GG
Primary Outcome Measure Information:
Title
Occurrence of allergic manifestations
Description
Occurrence of allergic manifestations in children with CMA including atopic eczema, allergic urticaria, asthma, allergic rhinitis.Information on social and demographic factors, family and living conditions, and smoking habits will be documented. Unscheduled visit will be made when possible allergic symptoms will appear. Every 12 months sensitization to common dietary and respiratory antigens will be assessed by skin prick tests (SPT) and prick by prick tests.
Time Frame
3 yrs
Secondary Outcome Measure Information:
Title
Allergic sensitization
Description
Every 12 months sensitization to common dietary and respiratory antigens will be assessed by skin prick tests (SPT) and prick by prick tests.
Time Frame
3 yrs
10. Eligibility
Sex
All
Maximum Age & Unit of Time
12 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
infants aged less than 12 months, with a diagnosis of cow's milk allergy
Exclusion Criteria:
age higher than 12 months,
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 proteins-induced anaphylaxis
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Roberto Berni Canani, Phd
Email
ritanocerino@alice.it
Facility Information:
Facility Name
University of Naples Federico II
City
Naples
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roberto Berni Canani
First Name & Middle Initial & Last Name & Degree
Roberto Berni Canani
12. IPD Sharing Statement
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Effect Of Lactobacillus GG on Atopic March
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