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Clinical Trials/NCT01181297
NCT01181297CompletedNot Applicable

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

Mead Johnson Nutrition2 sites in 2 countriesStarted: January 1, 2003Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Locations
2
Study OverviewEligibility CriteriaArms & InterventionsInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional

Eligibility Criteria

Ages
— to 14 Years (Child)
Accepts Healthy Volunteers
No

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

Arms & Interventions

Extensively Hydrolyzed Formula with a Probiotic

Experimental

Extensively Hydrolyzed Formula with a Probiotic

Intervention: Extensively Hydrolyzed Formula with a Probiotic (Other)

Extensively Hydrolyzed Formula without a Probiotic

Placebo Comparator

Intervention: Extensively Hydrolyzed Formula without a Probiotic (Other)

Investigators

Sponsor Class
Industry

Study Sites (2)

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