Cow's Milk Allergy and Functional Gastrointestinal Disorders

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:
NCT01901380
First received: July 3, 2013
Last updated: July 17, 2013
Last verified: July 2013
  Purpose

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 ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   4 Years to 6 Years
Genders Eligible for Study:   Both
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".

Criteria

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
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: NCT01901380

Contacts
Contact: Roberto Berni Cannai, MD, PhD +390817462680

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

No publications provided

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

Additional relevant MeSH terms:
Digestive System Diseases
Gastrointestinal Diseases
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 20, 2014