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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01891916
Other study ID # 109/11
Secondary ID
Status Recruiting
Phase N/A
First received June 28, 2013
Last updated July 15, 2013
Start date October 2008
Est. completion date December 2014

Study information

Verified date July 2013
Source Federico II University
Contact Roberto Berni Canani, Phd
Email ritanocerino@alice.it
Is FDA regulated No
Health authority Ethics Commitee of Naples':' "Carlo Romano"
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 180
Est. completion date December 2014
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender Both
Age group N/A to 12 Months
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Extensively hydrolyzed casein formula + LGG
Extensively hydrolyzed formula containing Lactobacillus GG

Locations

Country Name City State
Italy University of Naples Federico II Naples

Sponsors (1)

Lead Sponsor Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 3 yrs No
Secondary 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. 3 yrs No
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