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

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ClinicalTrials.gov Identifier: NCT01634490
Recruitment Status : Completed
First Posted : July 6, 2012
Last Update Posted : July 6, 2012
Sponsor:
Information provided by (Responsible Party):
Roberto Berni Canani, Federico II University

Study Description
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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.

Condition or disease
Cow's Milk Allergy

Study Design
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Study Type : Observational
Actual Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : October 2008
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month to 12 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.
Contacts and Locations
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Roberto Berni Canani, MD, PhD, Federico II University
ClinicalTrials.gov Identifier: NCT01634490    
Other Study ID Numbers: 013908
First Posted: July 6, 2012    Key Record Dates
Last Update Posted: July 6, 2012
Last Verified: July 2012
Keywords provided by Roberto Berni Canani, Federico II University:
cow's milk allergy
formulas
probiotics
Additional relevant MeSH terms:
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Hypersensitivity
Milk Hypersensitivity
Immune System Diseases
Food Hypersensitivity
Hypersensitivity, Immediate