ClinicalTrials.gov

History of Changes for Study: NCT01181297
Double Blind Controlled Trial of an Extensively Hydrolyzed Formula With a Probiotic vs. an Extensively Hydrolyzed Formula Without a Probiotic
Latest version (submitted August 12, 2010) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 August 12, 2010 None (earliest Version on record)
Comparison Format:

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Study NCT01181297
Submitted Date:  August 12, 2010 (v1)

Open or close this module Study Identification
Unique Protocol ID: 3369-2
Brief Title: Double Blind Controlled Trial of an Extensively Hydrolyzed Formula With a Probiotic vs. an Extensively Hydrolyzed Formula Without a Probiotic
Official Title:
Secondary IDs:
Open or close this module Study Status
Record Verification: August 2010
Overall Status: Completed
Study Start: January 2003
Primary Completion: November 2004 [Actual]
Study Completion: November 2004 [Actual]
First Submitted: August 12, 2010
First Submitted that
Met QC Criteria:
August 12, 2010
First Posted: August 13, 2010 [Estimate]
Last Update Submitted that
Met QC Criteria:
August 12, 2010
Last Update Posted: August 13, 2010 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Mead Johnson Nutrition
Responsible Party:
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:
Open or close this module Study Description
Brief Summary: The purpose of this study is to confirm the hypoallergenicity of an extensively hydrolyzed formula with an added probiotic in children with documented milk allergy.
Detailed Description:
Open or close this module Conditions
Conditions: Allergy
Keywords: Confirmed milk allergy
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Other
Study Phase: Not Applicable
Interventional Study Model:
Number of Arms: 2
Masking: (masked roles unspecified)
Enrollment:
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Extensively Hydrolyzed Formula with a Probiotic
Extensively Hydrolyzed Formula with a Probiotic
Extensively Hydrolyzed Formula with a Probiotic
Placebo Comparator: Extensively Hydrolyzed Formula without a Probiotic
Extensively Hydrolyzed Formula without a Probiotic
Open or close this module Outcome Measures
Open or close this module Eligibility
Minimum Age:
Maximum Age: 14 Years
Sex:
Gender Based:
Accepts Healthy Volunteers:
Criteria:

Inclusion Criteria:

  • ≤14 years of age
  • Essentially asymptomatic for a minimum of 7 days pre-challenge.
  • Successful previous consumption of Extensively Hydrolyzed Formula within 1 week of study enrollment
  • Medically documented allergy to cow's milk

Exclusion Criteria:

  • Presence of underlying systemic disease or other illness
  • Used Beta-blockers within 12-24 hours of challenges
  • Use of short-acting antihistamines within 3 days
  • Use of medium-acting antihistamines within 7 days
  • Use of long-acting antihistamines within 6 weeks
  • Use of oral steroid medication within 3 weeks
Open or close this module Contacts/Locations
Locations: Italy, Veneto
Dept. of Paediatrics, Azienda Ospedaliera di Padova
Padova, Veneto, Italy, 35128
Netherlands
Wilhelmina Children's Hospital
Utrecht, Netherlands, 3508
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services