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

NCT ID: NCT01634490

Last Updated: 2012-07-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-10-31

Study Completion Date

2012-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Cow's Milk Allergy

Keywords

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cow's milk allergy formulas probiotics

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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infants receiving extensively hydrolysed casein formula

infants receiving extensively hydrolysed casein formula as substitutive formula

No interventions assigned to this group

extensively hydrolysed casein formula with Lactobacillus GG

infants receiving extensively hydrolysed casein with LGG as substitutive formula

No interventions assigned to this group

infants receiving rice hydrolyzed formula

infants receiving rice hydrolyzed formula as substitutive formula

No interventions assigned to this group

infants receiving soy-based formula

infants receiving soy-based formula as substitutive formula

No interventions assigned to this group

infants receiving amino-acid based formula

infants receiving amino-acid based formula as substitutive formula

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

1 Month

Maximum Eligible Age

12 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Federico II University

OTHER

Sponsor Role lead

Responsible Party

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Roberto Berni Canani

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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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.

Reference Type DERIVED
PMID: 23582142 (View on PubMed)

Other Identifiers

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013908

Identifier Type: -

Identifier Source: org_study_id