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Effect Of Lactobacillus GG on Atopic March

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2013 by Roberto Berni Canani, Federico II University.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Roberto Berni Canani, Federico II University Identifier:
First received: June 28, 2013
Last updated: July 15, 2013
Last verified: July 2013
Food allergy (FA), defined as an adverse immune response to food allergens, is among the most frequent allergic disorders in childhood and it has recognized as a major paediatric health problem due to the severity of the reactions and the dramatic increase over the past decades. Cow's milk allergy (CMA) is the most frequent FA in children worldwide, and it has been demonstrated that it could be the first manifestation of the so-called "atopic march", characterized by the occurrence of other allergic disorders in the subsequent years after the onset of CMA. In a previous study, involving children with CMA over a period of 5 years, 40% developed asthma, 21% atopic eczema, and 43% allergic rhinitis. Similar results have been reported in a recent study on Finnish children Intestinal microflora appears to have a crucial role in the development of atopic disorders. Children with atopic diseases have different commensal bacterial groups in the gut compared to non-atopic children, and differences are also found between countries with high and low incidence of atopic diseases. There is currently great interest in manipulating the normal microbiota to accrue health benefits through an approach known as "probiotics." Probiotics are defined as "live microorganisms which when administered in adequate amounts confer a health benefit on the host". The conceptual basis of possible use of probiotics in the prevention and treatment of atopic disorders is well grounded. 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. This view has been further reinforced by recent research showing that LGG is able to improve recovery of intestinal symptoms in infants with CMA-induced allergic colitis.

Condition Intervention
Cow's Milk Allergy Atopic Disease Dietary Supplement: Extensively hydrolyzed casein formula + LGG

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Preventive Effect of Lactobacillus GG on Atopic Manifestation in Children With Cow's Milk Allergy

Resource links provided by NLM:

Further study details as provided by Roberto Berni Canani, Federico II University:

Primary Outcome Measures:
  • Occurrence of allergic manifestations [ Time Frame: 3 yrs ]
    Occurrence of allergic manifestations in children with CMA including atopic eczema, allergic urticaria, asthma, allergic rhinitis.Information on social and demographic factors, family and living conditions, and smoking habits will be documented. Unscheduled visit will be made when possible allergic symptoms will appear. Every 12 months sensitization to common dietary and respiratory antigens will be assessed by skin prick tests (SPT) and prick by prick tests.

Secondary Outcome Measures:
  • Allergic sensitization [ Time Frame: 3 yrs ]
    Every 12 months sensitization to common dietary and respiratory antigens will be assessed by skin prick tests (SPT) and prick by prick tests.

Estimated Enrollment: 180
Study Start Date: October 2008
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: extensively hydrolysed casein formula
extensively hydrolysed casein formula
Active Comparator: Extensively hydrolyzed casein formula + LGG
Extensively hydrolized formula plus LGG
Dietary Supplement: Extensively hydrolyzed casein formula + LGG
Extensively hydrolyzed formula containing Lactobacillus GG
Other Name: Extensively hydrolyzed formula plus LGG


Ages Eligible for Study:   up to 12 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • infants aged less than 12 months, with a diagnosis of cow's milk allergy

Exclusion Criteria:

  • age higher than 12 months,
  • concomitant 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 cow's milk proteins-induced anaphylaxis
  Contacts and Locations
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Please refer to this study by its identifier: NCT01891916

Contact: Roberto Berni Canani, Phd

University of Naples Federico II Recruiting
Naples, Italy
Contact: Roberto Berni Canani         
Principal Investigator: Roberto Berni Canani         
Sponsors and Collaborators
Federico II University
  More Information

Responsible Party: Roberto Berni Canani, MD, PhD, Federico II University Identifier: NCT01891916     History of Changes
Other Study ID Numbers: 109/11
Study First Received: June 28, 2013
Last Updated: July 15, 2013

Additional relevant MeSH terms:
Milk Hypersensitivity
Immune System Diseases
Food Hypersensitivity
Hypersensitivity, Immediate
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action processed this record on August 21, 2017