Clincosm LogoSign in Get a demo

Double Blind Controlled Trial of an Extensively Hydrolyzed Formula With a Probiotic vs. an Extensively Hydrolyzed Formula Without a Probiotic

Sponsor
Mead Johnson Nutrition (Industry)
Overall Status
Completed
CT.gov ID
NCT01181297
Collaborator
(none)
2
Locations
2
Arms
22
Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Extensively Hydrolyzed Formula with a Probiotic
  • Other: Extensively Hydrolyzed Formula without a Probiotic
 N/A

Study Design

Study Type:
Interventional
Study Start Date :
Jan 1, 2003
Actual Primary Completion Date :
Nov 1, 2004
Actual Study Completion Date :
Nov 1, 2004

Arms and Interventions

Arm Intervention/Treatment
Experimental: Extensively Hydrolyzed Formula with a Probiotic

Extensively Hydrolyzed Formula with a Probiotic

Other: Extensively Hydrolyzed Formula with a Probiotic
Placebo Comparator: Extensively Hydrolyzed Formula without a Probiotic

Other: Extensively Hydrolyzed Formula without a Probiotic

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 14 Years
    Sexes Eligible for Study:
    All
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Dept. of Paediatrics, Azienda Ospedaliera di Padova Padova Veneto Italy 35128
    2 Wilhelmina Children's Hospital Utrecht Netherlands 3508

    Sponsors and Collaborators

    • Mead Johnson Nutrition

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01181297
    Other Study ID Numbers:
    • 3369-2
    First Posted:
    Aug 13, 2010
    Last Update Posted:
    Aug 13, 2010
    Last Verified:
    Aug 1, 2010
    Keywords provided by , ,
    Confirmed milk allergy
    Additional relevant MeSH terms:
    Hypersensitivity

    Study Results

    No Results Posted as of Aug 13, 2010