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

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.
 
ClinicalTrials.gov Identifier: NCT01181297
Recruitment Status : Completed
First Posted : August 13, 2010
Last Update Posted : August 13, 2010
Sponsor:
Information provided by:
Mead Johnson Nutrition

Tracking Information
First Submitted Date  ICMJE August 12, 2010
First Posted Date  ICMJE August 13, 2010
Last Update Posted Date August 13, 2010
Study Start Date  ICMJE January 2003
Actual Primary Completion Date November 2004   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Double Blind Controlled Trial of an Extensively Hydrolyzed Formula With a Probiotic vs. an Extensively Hydrolyzed Formula Without a Probiotic
Official Title  ICMJE Not Provided
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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Not Provided
Condition  ICMJE Allergy
Intervention  ICMJE
  • Other: Extensively Hydrolyzed Formula with a Probiotic
  • Other: Extensively Hydrolyzed Formula without a Probiotic
Study Arms  ICMJE
  • Experimental: Extensively Hydrolyzed Formula with a Probiotic
    Extensively Hydrolyzed Formula with a Probiotic
    Intervention: Other: Extensively Hydrolyzed Formula with a Probiotic
  • Placebo Comparator: Extensively Hydrolyzed Formula without a Probiotic
    Intervention: Other: Extensively Hydrolyzed Formula without a Probiotic
Publications * Muraro A, Hoekstra MO, Meijer Y, Lifschitz C, Wampler JL, Harris C, Scalabrin DM. Extensively hydrolysed casein formula supplemented with Lactobacillus rhamnosus GG maintains hypoallergenic status: randomised double-blind, placebo-controlled crossover trial. BMJ Open. 2012 Mar 5;2(2):e000637. doi: 10.1136/bmjopen-2011-000637. Print 2012.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE November 2004
Actual Primary Completion Date November 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE Not Provided
Ages  ICMJE up to 14 Years   (Child)
Accepts Healthy Volunteers  ICMJE Not Provided
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy,   Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01181297
Other Study ID Numbers  ICMJE 3369-2
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Mead Johnson Nutrition
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Mead Johnson Nutrition
Verification Date August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP