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

Not Applicable

Completed

• Conditions: Allergy
• Interventions: Other: Extensively Hydrolyzed Formula with a Probiotic; Other: Extensively Hydrolyzed Formula without a Probiotic

• Registration Number: NCT01181297
• Lead Sponsor: Mead Johnson Nutrition

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 available

Study Timeline

• Study Start: 2003-01
• Primary Completion: 2004-11
• Study Completion: 2004-11
• Status Verified: 2010-08
• Study First Submitted: 2010-08-12
• Study First Submitted QC: 2010-08-12
• Last Update Submitted: 2010-08-12
• Study First Posted: 2010-08-13
• Last Update Posted: 2010-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Not specified
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Extensively Hydrolyzed Formula with a Probiotic	Extensively Hydrolyzed Formula with a Probiotic	Extensively Hydrolyzed Formula with a Probiotic
Extensively Hydrolyzed Formula without a Probiotic	Extensively Hydrolyzed Formula without a Probiotic	-

Trial Locations

Locations (2)

Dept. of Paediatrics, Azienda Ospedaliera di Padova; 🇮🇹 Padova, Veneto, Italy

Wilhelmina Children's Hospital; 🇳🇱 Utrecht, Netherlands