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Cow's Milk Allergy and Functional Gastrointestinal Disorders

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 Federico II University.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Roberto Berni Canani, Federico II University Identifier:
First received: July 3, 2013
Last updated: July 17, 2013
Last verified: July 2013
Cow's milk allergy (CMA) is the most common food allergy in early childhood, with an estimated incidence ranging between 2% and 3% in infants and marginally lower in older children. It has been demonstrated that it could be a risk factor for the development of the functional gastrointestinal disorders in children. Intestinal microflora has been indicated as potential target for the management of CMA and FGDIs through the use of probiotics. Lactobacillus rhamnosus GG (LGG) is the most studied probiotic. Recently, it has been demonstrated that an extensively hydrolyzed casein formula remains hypoallergenic following the addition of LGG, satisfying both the American Academy of Pediatrics guidelines. Lactobacillus GG exerts several benefits when added to an extensively hydrolyzed casein formula (Nutramigen LGG), including decreased severity of atopic dermatitis, improved recovery of intestinal symptoms in infants with CMA-induced allergic colitis, and faster induction of tolerance in infants with CMA. The mechanisms of these effects are multiple and exerted at different levels: epithelium, immune system and enteric nervous system. Studies and meta-analyses showed that LGG increases treatment success in children with functional gastrointestinal disorders.

Condition Intervention
Cow's Milk Allergy
Functional Gastrointestinal Disorders
Dietary Supplement: Extensively hydrolyzed casein formula + LGG

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Effect of Lactobacillus GG on the Appearance of Functional Gastrointestinal Disorders in Children With Cow's Milk Allergy

Resource links provided by NLM:

Further study details as provided by Federico II University:

Primary Outcome Measures:
  • Appearance of functional gastrointestinal disorders [ Time Frame: functional gastrointestinal disorders ]

Estimated Enrollment: 220
Study Start Date: February 2013
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
extensively hydrolysed casein formula + LGG
children receiving extensively hydrolysed casein formula plus Lactobacillus GG
Dietary Supplement: Extensively hydrolyzed casein formula + LGG
other formulas
children receiving formulas without supplementation of Lactobacillus GG
Dietary Supplement: Extensively hydrolyzed casein formula + LGG


Ages Eligible for Study:   4 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The study population will be enrolled from a cohort of about 300 children (aged from 4 to 6 yrs) with a history of sure diagnosis of CMA obtained in the first year of life treated with hypoallergenic formula for at least 6 months and who are already in follow-up at the Department of Pediatrics of University of Naples "Federico II".

Inclusion Criteria:

  • Children (aged from 4 to 6 yrs) with a history of sure diagnosis of cow's milk allergy obtained in the first year of life treated with hypoallergenic formula

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: NCT01901380

Contact: Roberto Berni Cannai, MD, PhD +390817462680

University of Naples Federico II Recruiting
Naples, Italy, 80131
Contact: Roberto Berni Canani, MD, PhD    +390817462680      
Sponsors and Collaborators
Federico II University
  More Information

Responsible Party: Roberto Berni Canani, MD, PhD, Federico II University Identifier: NCT01901380     History of Changes
Other Study ID Numbers: 204/12
Study First Received: July 3, 2013
Last Updated: July 17, 2013

Additional relevant MeSH terms:
Milk Hypersensitivity
Digestive System Diseases
Gastrointestinal Diseases
Pathologic Processes
Immune System Diseases
Food Hypersensitivity
Hypersensitivity, Immediate
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action processed this record on May 23, 2017