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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01181297

Enrollment

Unknown

Registered

2010-08-13

Start date

2003-01-31

Completion date

2004-11-30

Last updated

2010-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergy

Keywords

Confirmed milk allergy

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.

Interventions

OTHERExtensively Hydrolyzed Formula with a Probiotic

OTHERExtensively Hydrolyzed Formula without a Probiotic

Eligibility

Age

No minimum 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

Countries

Italy, Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 26, 2026