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Trial registered on ANZCTR


Registration number
ACTRN12611001068954
Ethics application status
Approved
Date submitted
19/09/2011
Date registered
13/10/2011
Date last updated
22/11/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Preventive effect of Lactobacillus GG on atopic manifestations in children with cow's milk allergy.
Scientific title
Prospective randomized controlled study on the capability of early nutritional intervention with an extensively hydrolyzed casein formula containing Lactobacillus GG (LGG) versus extensively hydrolyzed casein formula alone to influence the incidence and prevalence of other allergic manifestations and of sensitization to main allergens in children with cow's milk allergy: a 3 years follow-up.
Secondary ID [1] 262429 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Occurrence of allergic manifestations in children with cow's milk allergy. 268117 0
Condition category
Condition code
Diet and Nutrition 268263 268263 0 0
Other diet and nutrition disorders
Inflammatory and Immune System 268264 268264 0 0
Allergies
Oral and Gastrointestinal 268265 268265 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will consist in a oral administration of a commercially available extensively hydrolized casein formula (EHFC) containing Lactobacillus GG (for at least 1x10 6 CFU/g of formula powder). The amount of EHFC ranged from 500 to 1000 ml everyday until oral tolerance acquisition depending on the body weight and age of children. Children enrolled will receive this dietary intervention and oral food challenges will be performed to explore tolerance acquisition every 6 months until tolerance acquisition for 3 years.
Intervention code [1] 266799 0
Treatment: Other
Comparator / control treatment
The control group will receive commercially avaliable extensively hydrolized casein formula (EHCF) with the same composition with the exception of absence of LGG. Children enrolled will receive this dietary intervention and oral food challenges will be performed to explore tolerance acquisition every 6 months until tolerance acquisition for 3 years.
Control group
Active

Outcomes
Primary outcome [1] 268991 0
Occurrence of allergic manifestations in children with CMA including atopic eczema, allergic urticaria, asthma, allergic rhinitis. Every 12 months sensitization to common dietary and respiratory antigens will be assessed by skin prick tests (SPT) and prick by prick tests. Atopic manifestations will be accurately evaluated according to previously validated criteria. In particular, atopic eczema will be diagnosed on the basis of the modified diagnostic criteria: 1) typical morphology and distribution of skin lesions (face, neck and scalp, flexural folds, hands, and extensor sides of the extremities); 2) pruritis (signs of scratching); and 3) tendency toward chronicity (duration 14 days, chronically relapsing, or both). The morphologic diagnosis of atopic eczema will be confirmed on skin examination by a second physician with great experience in allergology. Final diagnosis will be obtained only if all 3 diagnostic criteria will fulfill. Allergic urticaria will be diagnosed if at least 2 episodes of itching eruptions or swelling with typical appearance, will be observed. In case of a single episode, positive allergy screening tests or provocation response with the suspected allergen will be evaluated for definite diagnosis. Allergic rhinitis will be diagnosed if the children will have on most days two or more of: nasal discharge, blockage, sneezing, and itching. For diagnosis, temporal relations will be established between these symptoms of allergic rhinitis, symptoms with allergen exposure, relief of symptoms by antihistamine treatment, and evidence of atopic sensitization (ie, positive allergy screening tests).
Diagnosis of asthma will be based on an algorithm created by an international pediatric asthma consensus group. Asthma will be diagnosed if a child will present chronic or recurrent cough, wheeze or shortness of breath, or both, suggestive of asthma, and if other diagnoses will be excluded and trial antiasthma treatment will be effective.
Timepoint [1] 268991 0
every 12 months for a total of 36 months after randomidation
Secondary outcome [1] 276769 0
Allergic sensitization in children with CMA. Every 12 months sensitization to common dietary and respiratory antigens will be assessed by skin prick tests (SPT) and prick by prick tests. Atopic manifestations will be accurately evaluated according to previously validated criteria.
Timepoint [1] 276769 0
every 12 months startin from baseline in a period of 36 months.

Eligibility
Key inclusion criteria
children with IgE-mediated CMA (confirmed by oral food challenge) who received as exclusion diet regimen EHCF or EHCF containing LGG for at least 6 months.
Minimum age
1 Days
Maximum age
12 Months
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
age at the enrolment higher than 12 months and presence of 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 CMP-induced anaphylaxis, still on exclusion diet with one of the two study formula or with another dietary regimen because CMA.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Study subjects were randomly allocated to one of the two groups of dietary interventions: group 1 received EHCF (Nutramigen -registrered trademark-, Mead Johnson, Italy), and group 2 received EHCF containing LGG (Nutramigen LGG -registrered trademark-, Mead Johnson, Italy).The computerized randomization schedule was prepared by a central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomisation table created by computer software (i.e., computerised sequence generation).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 0
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/10/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
160
Accrual to date
Final
Recruitment outside Australia
Country [1] 3634 0
Italy
State/province [1] 3634 0
Naples

Funding & Sponsors
Funding source category [1] 269896 0
Commercial sector/Industry
Name [1] 269896 0
Mead Johnson Nutrition
Country [1] 269896 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Mead Johnson Nutrition
Address
2400 West Lloyd Expressway, Evansville, IN - (812) 429-5000
zip code 47721
Country
United States of America
Secondary sponsor category [1] 268908 0
None
Name [1] 268908 0
Address [1] 268908 0
Country [1] 268908 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271868 0
Comitato Etico per le Attivita Biomediche
Ethics committee address [1] 271868 0
Universita degli Studi di Napoli Federico II
Prof. Claudio Buccelli
Via S. Pansini 5, 80131 Napoli
Ethics committee country [1] 271868 0
Italy
Date submitted for ethics approval [1] 271868 0
Approval date [1] 271868 0
29/07/2011
Ethics approval number [1] 271868 0
1/11/0109

Summary
Brief summary
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. Finally, we have recently demonstrated that the addition of LGG to an extensively hydrolysed casein formula is able to reduce the time of tolerance acquisition in children with CMA. The primary purpose of this study is to determine whether early nutritional intervention with LGG added to an extensively hydrolyzed casein formula (EHCF, Nutramigen LGG -registered trademark-, Mead Johnson, Italy) to treat CMA in children could be able to influence the incidence and prevalence of other allergic manifestations and of sensitization to main allergens in a follow-up of 3 years.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32762 0
Address 32762 0
Country 32762 0
Phone 32762 0
Fax 32762 0
Email 32762 0
Contact person for public queries
Name 16009 0
Linda Cosenza
Address 16009 0
Via Pansini, 5
80131 Napoli
Country 16009 0
Italy
Phone 16009 0
+390817462680
Fax 16009 0
Email 16009 0
[email protected]
Contact person for scientific queries
Name 6937 0
Linda Cosenza
Address 6937 0
Via Pansini, 5
80131 Napoli
Country 6937 0
Italy
Phone 6937 0
+390817462680
Fax 6937 0
Email 6937 0
[email protected]

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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