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Tolerance to a New Free Amino Acid-based Formula in Children With IgE or Non-IgE-mediated Cow's Milk Allergy

NCT01622426 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2012-06-19

No results posted yet for this study

Summary

The investigators aim to assess the tolerance to a new commercially available Aaf in children affected by IgE- or non-IgE-mediated CMA.

Conditions

  • Cow's Milk Allergy

Interventions

DIETARY_SUPPLEMENT

tolerance to a new aminoacid based formula

Every 20 minutes, successive doses (0.1, 0.3, 1, 3, 10, 30 and 100 mL) of placebo (the commercially available Aaf Neocate, Nutricia, Milan, Italy) or of the study formula (Sineall, Humana, Milan, Italy) were administered.

DIETARY_SUPPLEMENT

Amino acid formula

Every 20 minutes, successive doses (0.1, 0.3, 1, 3, 10, 30 and 100 mL) of placebo (the commercially available Aaf Neocate, Nutricia, Milan, Italy) or of the study formula (Sineall, Humana, Milan, Italy) were administered.

Sponsors & Collaborators

  • Federico II University

    lead OTHER

Principal Investigators

  • Roberto Berni Canani, MD, PhD · Federico II University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
1 Month
Max Age
168 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2010-06-30
Completion
2011-10-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01622426 on ClinicalTrials.gov