Effect Of Lactobacillus GG on Atopic March

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Federico II University
Sponsor:
Information provided by (Responsible Party):
Roberto Berni Canani, Federico II University
ClinicalTrials.gov Identifier:
NCT01891916
First received: June 28, 2013
Last updated: July 15, 2013
Last verified: July 2013
  Purpose

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: 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 Federico II University:

Primary Outcome Measures:
  • Occurrence of allergic manifestations [ Time Frame: 3 yrs ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

  Eligibility

Ages Eligible for Study:   up to 12 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01891916

Contacts
Contact: Roberto Berni Canani, Phd ritanocerino@alice.it

Locations
Italy
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

No publications provided

Responsible Party: Roberto Berni Canani, MD, PhD, Federico II University
ClinicalTrials.gov Identifier: NCT01891916     History of Changes
Other Study ID Numbers: 109/11
Study First Received: June 28, 2013
Last Updated: July 15, 2013
Health Authority: Ethics Commitee of Naples':' "Carlo Romano"

Additional relevant MeSH terms:
Hypersensitivity
Milk Hypersensitivity
Immune System Diseases
Food Hypersensitivity
Hypersensitivity, Immediate
Caseins
Chelating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014