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

July 5, 2012 updated by: Roberto Berni Canani, Federico II University
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

300

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the effect of different dietotherapeutic approaches on the time of tolerance acquisition in children with cow's milk allergy
Time Frame: about 4 year
. 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federico II University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

July 3, 2012

First Submitted That Met QC Criteria

July 5, 2012

First Posted (Estimate)

July 6, 2012

Study Record Updates

Last Update Posted (Estimate)

July 6, 2012

Last Update Submitted That Met QC Criteria

July 5, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 013908

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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