Not Yet RecruitingEarly Phase 1ACTRN12611001068954

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.

Sponsor

Mead Johnson Nutrition

Enrollment

160 participants

Start Date

Oct 15, 2011

Study Type

Interventional

Conditions

Occurrence of allergic manifestations in children with cow's milk allergy.

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.

Eligibility

Sex: Both males and femalesMin Age: 1 DaysMax Age: 12 Monthss

Plain Language Summary

Simplified for easier understanding

This study investigates whether the probiotic Lactobacillus GG can help prevent allergic conditions such as eczema in infants who have been diagnosed with cow's milk allergy. It follows babies under 12 months who were previously treated with specialized hypoallergenic formula containing the probiotic.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 tolerance acquisition for 3 years.

Locations(1)

Naples, Italy

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ACTRN12611001068954