Cow's Milk Allergy and Functional Gastrointestinal Disorders

Functional Gastrointestinal Disorders Clinical Trial

Official title:

Effect of Lactobacillus GG on the Appearance of Functional Gastrointestinal Disorders in Children With Cow's Milk Allergy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01901380
• Other study ID #: 204/12
• Status: Completed
• Phase: N/A
• First received: July 3, 2013
• Last updated: July 27, 2017
• Start date: February 2013
• Est. completion date: August 2014

Study information

• Verified date: July 2017
• Source: Federico II University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 6 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cow's Milk Allergy
• Digestive System Diseases
• Disease
• Functional Gastrointestinal Disorders
• Gastrointestinal Diseases
• Hypersensitivity
• Milk Hypersensitivity

Intervention

Dietary Supplement:
• Extensively hydrolyzed casein formula + LGG

Locations

Country	Name	City	State
Italy	University of Naples Federico II	Naples

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Appearance of functional gastrointestinal disorders		functional gastrointestinal disorders