Preventive effect of Lactobacillus GG on atopic manifestations in children with cow's milk allergy.

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.

Status

Not yet recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611001068954

Enrollment

160

Registered

2011-10-13

Start date

2011-10-15

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

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.

Interventions

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 toler

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

1 Days to 12 Months

Healthy volunteers

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.

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.

Outcome results