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

August 12, 2010 updated by: Mead Johnson Nutrition
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Veneto
      • Padova, Veneto, Italy, 35128
        • Dept. of Paediatrics, Azienda Ospedaliera di Padova
  • Netherlands
      • Utrecht, Netherlands, 3508
        • Wilhelmina Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 14 years (Child)

Accepts Healthy Volunteers

N/A

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mead Johnson Nutrition

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2003

Primary Completion (Actual)

November 1, 2004

Study Completion (Actual)

November 1, 2004

Study Registration Dates

First Submitted

August 12, 2010

First Submitted That Met QC Criteria

August 12, 2010

First Posted (Estimate)

August 13, 2010

Study Record Updates

Last Update Posted (Estimate)

August 13, 2010

Last Update Submitted That Met QC Criteria

August 12, 2010

Last Verified

August 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3369-2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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