Cow's Milk Allergy and Functional Gastrointestinal Disorders

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.

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Key information

Conditions

Cow's Milk Allergy Digestive System Diseases Food Hypersensitivity Functional Gastrointestinal Disorders Gastrointestinal Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Milk Hypersensitivity

Age range

4 year–6 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Naples Federico II

Naples, 80131, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Extensively hydrolyzed casein formula + LGG

Dietary Supplement

Primary outcomes

Appearance of functional gastrointestinal disorders

Time frame: functional gastrointestinal disorders

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Registry information

Official study title

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

Important dates

Study start: 2013
Primary completion: 2014
Study completion: 2014
First posted: Jul 17, 2013
Registry last updated: Jul 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed