Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000566033
Ethics application status
Approved
Date submitted
22/06/2010
Date registered
13/07/2010
Date last updated
13/07/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
effect of Lactobacillus GG on tolerance acquisition in children with cow's milk allergy
Scientific title
A randomised controlled trial on the effect of extensively hydrolyzed casein formula containing Lactobacillus GG (LGG) versus extensively hydrolyzed casein formula on time of tolerance acquisition in children with cow's milk allergy
Secondary ID [1] 252075 0
none
Universal Trial Number (UTN)
U1111-1115-5667
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Children with cow's milk allergy 257613 0
Condition category
Condition code
Oral and Gastrointestinal 257791 257791 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Diet and Nutrition 257859 257859 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will consist in a oral administration of a commercially avaliable extensively hydrolyzed casein formula (EHCF) containing LGG (concentration was 2,50x 10 7 to 5x10 8 colony-forming units /CFU/g).
The amount of EHCF ranged from 500 to 1000 ml per day depending on the body weight and age of children. Children enrolled will receive this dietary intervention untill tolerance will be acquired as demonstrated by oral food challenge (OFC)
Intervention code [1] 256700 0
Treatment: Other
Comparator / control treatment
The control group will receive commercially avaliable extensively hydrolyzed casein formula (EHCF) with the same composition with the exception of absence of LGG
Control group
Active

Outcomes
Primary outcome [1] 258660 0
time of tolerance acquisition in children affected by cow's milk allergy (CMA). This outcome is assessed by performing oral food challenge (OFC)
Timepoint [1] 258660 0
Every 3 months starting from baselin until the appearance of oral tolerance in a period of 12 months
Secondary outcome [1] 264638 0
nil
Timepoint [1] 264638 0
nil

Eligibility
Key inclusion criteria
children consecutively referred to our tertiary Pediatric Gastroenterology and Allergology Center for suspected CMA-related gastrointestinal symptoms (vomiting, diarrhea, abdominal pain, blood and mucus in the stool)
Minimum age
1 Months
Maximum age
24 Months
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children with 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 and malformations of the gastrointestinal tract

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients will be allocated into one of the 2 groups according to a computer-generated randomization list.
The list will be concealed and parents of enrolled children received a sealed opaque envelope containing instruction about dietary product to be used
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation by using block randomisation created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/10/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
66
Accrual to date
Final
Recruitment outside Australia
Country [1] 2705 0
Italy
State/province [1] 2705 0
Napoli

Funding & Sponsors
Funding source category [1] 257166 0
Commercial sector/Industry
Name [1] 257166 0
Mead Johnson
Country [1] 257166 0
United States of America
Primary sponsor type
University
Name
Dipartment of Pediatrics University of Naples Federico II
Address
via Pansini 5 80131, Napoli
Country
Italy
Secondary sponsor category [1] 256423 0
None
Name [1] 256423 0
Address [1] 256423 0
Country [1] 256423 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259208 0
Ethics committee address [1] 259208 0
Ethics committee country [1] 259208 0
Italy
Date submitted for ethics approval [1] 259208 0
05/06/2008
Approval date [1] 259208 0
11/06/2008
Ethics approval number [1] 259208 0

Summary
Brief summary
BACKGROUND. Lactobacillus GG (LGG) modulates immune function and has been proposed in the prevention and treatment of pediatric allergic diseases.

AIM. We investigated whether the addition of LGG to an extensively hydrolyzed casein formula (EHCF) could be able to influence the time of tolerance acquisition in children affected by cow’s milk allergy (CMA).

METHODS. Children (1-24 months of age) affected by immunoglobulin E (IgE) and non immunoglobulin E (non-IgE) mediated CMA, confirmed by oral food challenge, were randomly allocated to two different dietary interventions: 1, EHCF (Nutramigen'Registered Trademark (R)', Mead Johnson, Italy); 2, EHCF containing LGG for at least 1x106 CFU/g of formula powder LGG (Nutramigen LGG 'Registered Trademark (R)', Mead Johnson, Italy). To investigate the possible tolerance acquisition an oral food challenge was performed every 3 months after diagnosis for 12 months.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31318 0
Address 31318 0
Country 31318 0
Phone 31318 0
Fax 31318 0
Email 31318 0
Contact person for public queries
Name 14565 0
Prof. R. Berni Canani
Address 14565 0
via Pansini 5 80131 Napoli, Italia
Country 14565 0
Italy
Phone 14565 0
+0039 0817462680
Fax 14565 0
+00 39 0817462680
Email 14565 0
[email protected]
Contact person for scientific queries
Name 5493 0
Prof. R. Berni Canani
Address 5493 0
via Pansini 5 80131 Napoli, Italia
Country 5493 0
Italy
Phone 5493 0
+00 39 0817462680
Fax 5493 0
+00 39 0817462680
Email 5493 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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