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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01181297
First Posted: August 13, 2010
Last Update Posted: August 13, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Mead Johnson Nutrition
  Purpose
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 Intervention
Allergy Other: Extensively Hydrolyzed Formula with a Probiotic Other: Extensively Hydrolyzed Formula without a Probiotic

Study Type: Interventional

Further study details as provided by Mead Johnson Nutrition:

Study Start Date: January 2003
Study Completion Date: November 2004
Primary Completion Date: November 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   up to 14 Years   (Child)
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01181297


Locations
Italy
Dept. of Paediatrics, Azienda Ospedaliera di Padova
Padova, Veneto, Italy, 35128
Netherlands
Wilhelmina Children's Hospital
Utrecht, Netherlands, 3508
Sponsors and Collaborators
Mead Johnson Nutrition
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT01181297     History of Changes
Other Study ID Numbers: 3369-2
First Submitted: August 12, 2010
First Posted: August 13, 2010
Last Update Posted: August 13, 2010
Last Verified: August 2010

Keywords provided by Mead Johnson Nutrition:
Confirmed milk allergy