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NCT01181297 Clinical Trial

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

Allergy Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01181297
Other study ID # 3369-2
Secondary ID
Status Completed
Phase N/A
First received August 12, 2010
Last updated August 12, 2010
Start date January 2003
Est. completion date November 2004

Study information
Verified date August 2010
Source Mead Johnson Nutrition
Contact n/a
Is FDA regulated No
Health authority The Netherlands: Medisch Ethische Toetsingscommissie
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date November 2004
Est. primary completion date November 2004
Accepts healthy volunteers
Gender Both
Age group N/A to 14 Years
Eligibility 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

N/A

Related Conditions & MeSH terms

Intervention

Other:
• Extensively Hydrolyzed Formula with a Probiotic

• Extensively Hydrolyzed Formula without a Probiotic

Locations
Country Name City State
Italy Dept. of Paediatrics, Azienda Ospedaliera di Padova Padova Veneto
Netherlands Wilhelmina Children's Hospital Utrecht

Sponsors (1)
Lead Sponsor Collaborator
Mead Johnson Nutrition

Countries where clinical trial is conducted

Italy,  Netherlands, 

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