We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Cow's Milk Allergy and Functional Gastrointestinal Disorders

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01901380
First Posted: July 17, 2013
Last Update Posted: July 31, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Roberto Berni Canani, Federico II University
  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: Cohort
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 Roberto Berni Canani, Federico II University:

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

Enrollment: 220
Study Start Date: February 2013
Study Completion Date: August 2014
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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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".
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01901380


Locations
Italy
University of Naples Federico II
Naples, Italy, 80131
Sponsors and Collaborators
Federico II University
  More Information

Responsible Party: Roberto Berni Canani, MD, PhD, Federico II University
ClinicalTrials.gov Identifier: NCT01901380     History of Changes
Other Study ID Numbers: 204/12
First Submitted: July 3, 2013
First Posted: July 17, 2013
Last Update Posted: July 31, 2017
Last Verified: July 2017

Additional relevant MeSH terms:
Disease
Hypersensitivity
Digestive System Diseases
Gastrointestinal Diseases
Milk Hypersensitivity
Pathologic Processes
Immune System Diseases
Food Hypersensitivity
Hypersensitivity, Immediate
Caseins
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action