effect of Lactobacillus GG on tolerance acquisition in children with cow's milk allergy

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12610000566033

Enrollment

Registered

2010-07-13

Start date

2008-10-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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)

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

1 Months to 24 Months

Healthy volunteers

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)

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

Outcome results