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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2003-01-31

Study Completion Date

2004-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Allergy

Study Groups

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Extensively Hydrolyzed Formula with a Probiotic

Group Type EXPERIMENTAL

Extensively Hydrolyzed Formula with a Probiotic

Intervention Type OTHER

Extensively Hydrolyzed Formula without a Probiotic

Group Type PLACEBO_COMPARATOR

Extensively Hydrolyzed Formula without a Probiotic

Intervention Type OTHER

Interventions

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Extensively Hydrolyzed Formula with a Probiotic

Intervention Type OTHER

Extensively Hydrolyzed Formula without a Probiotic

Intervention Type OTHER

Eligibility Criteria

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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

Maximum Eligible Age

14 Years

Eligible Sex

Accepts Healthy Volunteers

No