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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Roberto Berni Canani, Federico II University
ClinicalTrials.gov Identifier:
NCT01634490
First received: July 3, 2012
Last updated: July 5, 2012
Last verified: July 2012
  Purpose

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
Cow's Milk Allergy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Federico II University:

Primary Outcome Measures:
  • the effect of different dietotherapeutic approaches on the time of tolerance acquisition in children with cow's milk allergy [ Time Frame: about 4 year ] [ Designated as safety issue: No ]
    . 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.


Enrollment: 300
Study Start Date: October 2008
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

Ages Eligible for Study:   1 Month to 12 Months
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided by Federico II University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Roberto Berni Canani, MD, PhD, Federico II University
ClinicalTrials.gov Identifier: NCT01634490     History of Changes
Other Study ID Numbers: 013908
Study First Received: July 3, 2012
Last Updated: July 5, 2012
Health Authority: Italy: Ethics Committee

Keywords provided by Federico II University:
cow's milk allergy
formulas
probiotics

Additional relevant MeSH terms:
Hypersensitivity
Milk Hypersensitivity
Immune System Diseases
Food Hypersensitivity
Hypersensitivity, Immediate

ClinicalTrials.gov processed this record on July 22, 2014