Effects of Different Dietary Regimens on Tolerance Acquisition in Children With Cow's Milk Allergy

NCT01634490 | Completed

• 1 other identifier: 013908
• Study Type: observational
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief Summary

Otherwise healthy infants (1-12 months of age at the diagnosis) with CMA were prospectively evaluated. Patients with cow's milk protein-induced anaphylaxis, eosinophilic disorders of the gastrointestinal tract, and food protein induced enterocolitic syndrome were excluded. A food challenge was performed 6 and 12 months after the diagnosis to assess clinical tolerance acquisition. Main demographic and clinical characteristics were collected for each patient.

Conditions

Cow's Milk Allergy

Keywords

cow's milk allergy; formulas; probiotics

Outcome Measures

Primary Outcomes (1)

• the effect of different dietotherapeutic approaches on the time of tolerance acquisition in children with cow's milk allergy

  . Otherwise healthy infants (1-12 months of age at the diagnosis) with CMA were prospectively evaluated. Patients with cow's milk protein-induced anaphylaxis, eosinophilic disorders of the gastrointestinal tract, and food protein induced enterocolitic syndrome were excluded. A food challenge was performed 6 and 12 months after the diagnosis to assess clinical tolerance acquisition. Main demographic and clinical characteristics were collected for each patient.

  about 4 year

Study Arms (5)

infants receiving extensively hydrolysed casein formula

infants receiving extensively hydrolysed casein formula as substitutive formula

extensively hydrolysed casein formula with Lactobacillus GG

infants receiving extensively hydrolysed casein with LGG as substitutive formula

infants receiving rice hydrolyzed formula

infants receiving rice hydrolyzed formula as substitutive formula

infants receiving soy-based formula

infants receiving soy-based formula as substitutive formula

infants receiving amino-acid based formula

infants receiving amino-acid based formula as substitutive formula

Eligibility Criteria

• Age: 1 Month - 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

We prospectively evaluated otherwise healthy infants (1-12 months of age at the diagnosis) visit one the Pediatric Gastroenterology and Allergology Centre because of the necessity of a diagnostic oral food challenge for cow's milk proteins. Children were in stable clinical condition without signs of CMA already on exclusion diet with an hypoallergenic formula for a period of 7-15 days as presented by the general paediatrician, immediately the symptoms appear and before being attended at the Center for diagnosis of CMA.

You may qualify if:

• Otherwise healthy infants (1-12 months of age at the diagnosis) with cow's milk allergy were prospectively evaluated

You may not qualify if:

• Patients with cow's milk protein-induced anaphylaxis, eosinophilic disorders of the gastrointestinal tract, and food protein induced enterocolitic syndrome were excluded.

Sponsors & Collaborators

• Federico II University: lead

Related Publications (1)

• Berni Canani R, Nocerino R, Terrin G, Frediani T, Lucarelli S, Cosenza L, Passariello A, Leone L, Granata V, Di Costanzo M, Pezzella V, Troncone R. Formula selection for management of children with cow's milk allergy influences the rate of acquisition of tolerance: a prospective multicenter study. J Pediatr. 2013 Sep;163(3):771-7.e1. doi: 10.1016/j.jpeds.2013.03.008. Epub 2013 Apr 10.

  PMID: 23582142 DERIVED

MeSH Terms

Conditions

Milk Hypersensitivity

Condition Hierarchy (Ancestors)

Food Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune 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, 2012
• First Posted: July 6, 2012
• Study Start: October 1, 2008
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: July 6, 2012

Record last verified: 2012-07