Cow's Milk Allergy and Functional Gastrointestinal Disorders

NCT01901380 | Completed

• 1 other identifier: 204/12
• Study Type: observational
• Target: 220
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cow's Milk Allergy; Functional Gastrointestinal Disorders

Outcome Measures

Primary Outcomes (1)

• Appearance of functional gastrointestinal disorders

  functional gastrointestinal disorders

Study Arms (2)

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

Interventions

Extensively hydrolyzed casein formula + LGG DIETARY_SUPPLEMENT

extensively hydrolysed casein formula + LGG; other formulas

Eligibility Criteria

• Age: 4 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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".

You may qualify if:

• 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

You may not qualify if:

• 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,

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

University of Naples Federico II

Naples, 80131, Italy

Location

MeSH Terms

Conditions

Milk Hypersensitivity; Gastrointestinal Diseases

Condition Hierarchy (Ancestors)

Food Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Digestive System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: July 3, 2013
• First Posted: July 17, 2013
• Study Start: February 1, 2013
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: July 31, 2017

Record last verified: 2017-07

Locations

IT (1)