Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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.
Information provided by:
Mead Johnson Nutrition Identifier:
First received: August 12, 2010
Last updated: NA
Last verified: August 2010
History: No changes posted

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

Study Type: Interventional

Resource links provided by NLM:

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


Ages Eligible for Study:   up to 14 Years

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
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01181297

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

No publications provided Identifier: NCT01181297     History of Changes
Other Study ID Numbers: 3369-2
Study First Received: August 12, 2010
Last Updated: August 12, 2010
Health Authority: The Netherlands: Medisch Ethische Toetsingscommissie

Keywords provided by Mead Johnson Nutrition:
Confirmed milk allergy processed this record on March 03, 2015