Back to resultsDouble Blind Controlled Trial of an Extensively Hydrolyzed Formula With a Probiotic vs. an Extensively Hydrolyzed Formula Without a Probiotic
Primary Purpose
Allergy
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Extensively Hydrolyzed Formula with a Probiotic
Extensively Hydrolyzed Formula without a Probiotic
Sponsored by
About this trial
This is an interventional trial for Allergy focused on measuring Confirmed milk allergy
Eligibility 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
Sites / Locations
- Dept. of Paediatrics, Azienda Ospedaliera di Padova
- Wilhelmina Children's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Extensively Hydrolyzed Formula with a Probiotic
Extensively Hydrolyzed Formula without a Probiotic
Arm Description
Extensively Hydrolyzed Formula with a Probiotic
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT01181297
First Posted
August 12, 2010
Last Updated
August 12, 2010
Sponsor
Mead Johnson Nutrition
1. Study Identification
Unique Protocol Identification Number
NCT01181297
Brief Title
Double Blind Controlled Trial of an Extensively Hydrolyzed Formula With a Probiotic vs. an Extensively Hydrolyzed Formula Without a Probiotic
Study Type
Interventional
2. Study Status
Record Verification Date
August 2010
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
November 2004 (Actual)
Study Completion Date
November 2004 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Mead Johnson Nutrition
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergy
Keywords
Confirmed milk allergy
7. Study Design
Study Phase
Not Applicable
8. Arms, Groups, and Interventions
Arm Title
Extensively Hydrolyzed Formula with a Probiotic
Arm Type
Experimental
Arm Description
Extensively Hydrolyzed Formula with a Probiotic
Arm Title
Extensively Hydrolyzed Formula without a Probiotic
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
Extensively Hydrolyzed Formula with a Probiotic
Intervention Type
Other
Intervention Name(s)
Extensively Hydrolyzed Formula without a Probiotic
10. Eligibility
Maximum Age & Unit of Time
14 Years
Eligibility 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
Facility Information:
Facility Name
Dept. of Paediatrics, Azienda Ospedaliera di Padova
City
Padova
State/Province
Veneto
ZIP/Postal Code
35128
Country
Italy
Facility Name
Wilhelmina Children's Hospital
City
Utrecht
ZIP/Postal Code
3508
Country
Netherlands
12. IPD Sharing Statement
Citations:
PubMed Identifier
22396223
Citation
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.
Results Reference
derived
Learn more about this trial
Double Blind Controlled Trial of an Extensively Hydrolyzed Formula With a Probiotic vs. an Extensively Hydrolyzed Formula Without a Probiotic
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